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TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)
Recruiting
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The purpose of this clinical trial is to learn about the safety and effects of the study
medicine (called ARV-471) when given together with other medicines for the potential
treatment of advanced or metastatic breast cancer.
This study is seeking participants who have breast cancer that:
- is advanced, may have spread to other organs (metastatic) and cannot be fully treated by
surgery or radiation therapy
- is sensitive to hormonal therapy (it is called estrogen receptor positive); and
- is no longer responding to previous treatments This study is divided into separate
sub-studies.
For Sub-Study A:
All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be
given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a
day. We will examine the experiences of people receiving the study medicines. This will help
us determine if the study medicines are safe and effective.
Participants will continue to take ARV-471 and abemaciclib until their cancer is no longer
responding, or side effects become too severe. They will have visits at the study clinic
about every 4 weeks.
Stanford Investigators
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TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B)
Recruiting
More
The purpose of this clinical trial is to learn about the safety and effects of the study
medicine (called ARV-471) when given together with other medicines for the potential
treatment of advanced or metastatic breast cancer.
This study is seeking participants who have breast cancer that:
- is advanced, may have spread to other organs (metastatic) and cannot be fully treated by
surgery or radiation therapy
- is sensitive to hormonal therapy (it is called estrogen receptor positive); and
- is no longer responding to previous treatments
This study is divided into separate sub-studies.
For Sub-Study B:
All participants will receive ARV-471 and a medicine called ribociclib. ARV-471 and
ribociclib will be given at the same time by mouth, at home, 1 time a day.
The experiences of people receiving the study medicine will be examined. This will help
determine if the study medicine is safe and effective.
Participants will continue to take ARV-471 and ribociclib until their cancer is no longer
responding, or side effects become too severe. They will have visits at the study clinic
about every 4 weeks.
Stanford Investigators
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Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
Not Recruiting
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This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy
without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple
negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule
agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in
a class of medications known as platinum-containing compounds. It works in a way similar to
the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works
by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of
medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid
(DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is
in a class of medications called taxanes. It stops cancer cells from growing and dividing and
may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may
kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work
the same as the usual anthracycline chemotherapy treatment for early-stage triple negative
breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Recruiting
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This is a Phase III open-label study to assess if camizestrant improves outcomes compared to
standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate
or high risk for disease recurrence who completed definitive locoregional therapy (with or
without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and
up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
Stanford Investigators
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Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
Not Recruiting
More
This study will assess the efficacy and safety of Niraparib in participants with either tumor
mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor
[HR] status, including HR positive [+] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with
molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA)
following surgery or completion of adjuvant therapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Recruiting
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This is an umbrella study evaluating the efficacy and safety of multiple treatment
combinations in participants with metastatic or inoperable locally advanced breast cancer.
The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in
parallel in this study:
Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have
received no prior systemic therapy for metastatic or inoperable locally advanced
triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort).
Cohort 2 will consist of participants who had disease progression during or following 1L
treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not
received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort).
Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative
disease with PIK3CA mutation who may or may not have had disease progression during or
following previous lines of treatment for metastatic disease (HR+cohort).
Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low
disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+
/HER2-low cohort).
In each cohort, eligible participants will initially be assigned to one of several treatment
arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease
progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be
eligible to continue treatment with a different treatment combination (Stage 2), provided
Stage 2 is open for enrollment.
Stanford Investigators
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T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
Recruiting
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This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches
to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors,
and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some
of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in
preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared
to T-DM1 alone.
Stanford Investigators
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A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
Not Recruiting
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This multicenter, randomized, double-blind study evaluated the efficacy, safety, and
pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with
placebo in combination with nab-paclitaxel in participants with locally advanced or
metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy
for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been
determined in previous studies of participants with mBC and the safety data to date suggest
that atezolizumab can be safely combined with standard chemotherapy agents.
Stanford is currently not accepting patients for this trial.
For more information, please contact Janet Pan, 650-723-0628.
Stanford Investigators
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A Study of HMBD-002, a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab
Recruiting
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This is a phase 1/2, open-label, multi-center, first-in-human, two-stage (Part 1: dose
escalation and Part 2: dose expansion) study evaluating multiple doses and schedules of
intravenously (IV) administered HMBD-002, with or without pembrolizumab, in patients with
advanced solid tumors (i.e., locally advanced and unresectable, or metastatic).
Stanford Investigators
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A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
Recruiting
More
This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety,
tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib
(IBRANCE®) in patients with estrogen receptor positive/human epidermal growth factor receptor
2 negative (ER+/HER2-) locally advanced or metastatic breast cancer, who have received prior
hormonal therapy and chemotherapy in the locally advanced/metastatic setting.
Stanford Investigators
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A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
Recruiting
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This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants
with breast cancer. Cohort 1 will focus on participants with inoperable, locally advanced or
metastatic, estrogen receptor (ER)-positive, HER2-negative breast cancer who had disease
progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor
(CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting.
Cohort 2 will focus on inoperable, locally advanced or metastatic, ER-positive, HER2-positive
breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one
was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if
recurrence occurred within 6 months of finishing adjuvant therapy) and one was a
HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or
trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib,
lapatinib, pyrotinib or neratinib). The study is designed with the flexibility to open new
treatment arms as new treatments become available, close existing treatment arms that
demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient
population. During Stage 1, participants in each cohort will be randomly assigned to
treatment arms. Participants in the control or experimental arms who experience unacceptable
toxicity, disease progression as determined by the investigator according to RECIST v1.1, or
loss of clinical benefit as determined by the investigator during Stage 1 will be given the
option of receiving a different treatment combination during Stage 2, provided they meet
eligibility criteria and a treatment arm is open for enrollment. No Stage 2 treatment is
currently available.
Stanford Investigators
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Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
Recruiting
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The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie,
a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who
will or will not experience benefit from treatment with capecitabine. Participants will be
monitored for changes in ctDNA in the blood over time received during capecitabine treatment.
Results of ctDNA analysis will be correlated to genetic characteristics of individual tumors.
This may inform future clinical trials in which patients could receive a different treatment
than capecitabine to reduce their risk of breast cancer relapse.
Lead Sponsor
Stanford Investigators
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Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer
Recruiting
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This purpose of this study is to test if talazoparib is safe and evaluate its response to
advanced breast cancer associated with mutation of gene called PALB.
Lead Sponsor
Stanford Investigators
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CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy
Not Recruiting
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This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating
further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer
who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after
pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as
paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and
pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to
specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When
these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and
the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel,
trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without
compromising patient outcomes compared to the usual treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug
Not Recruiting
More
The purpose of the study is to test how well patients with advanced solid tumors respond to
treatment with elimusertib (BAY1895344) in combination with pembrolizumab. In addition
researchers want to find for patients the optimal dose of elimusertib in combination with
pembrolizumab, how the drug is tolerated and the way the body absorbs, distributes and
discharges the drug. The study medication, elimusertib, works by blocking a substance (ATR
Kinase) which is produced by the body and is important for the growth of tumor cells.
Pembrolizumab is an immunologic checkpoint blocker that promotes an immune response against
the tumor.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
Not Recruiting
More
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475)
versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant
(post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage
estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-)
breast cancer.
The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in
combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by
pathological Complete Response (pCR) rate defined by the local pathologist, and 2)
pembrolizumab is superior to placebo (both in combination with the protocol-specified
neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as
determined by the investigator. The study is considered to have met its primary objective if
pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.
Stanford is currently not accepting patients for this trial.
For more information, please contact Study Coordinator, 650-723-0658.
Stanford Investigators
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A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Not Recruiting
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This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab
and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC)
previously untreated in this setting.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
Not Recruiting
More
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several
immunotherapy-based combination treatments in participants with inoperable locally advanced
or metastatic HR-positive, HER2-negative breast cancer who have progressed during or
following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or
second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be
performed in two stages. During Stage 1, participants will be randomized to fulvestrant
(control) or an atezolizumab-containing doublet or triplet combination. Those who experience
disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to
receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or
unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be
closed during the course of the study on the basis of ongoing clinical efficacy and safety as
well as the current treatments available.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
Not Recruiting
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A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR
NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH
FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC
Not Recruiting
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This is a Phase 2, Multi-Cohort, Open-Label, Multi-Center Study. Cohort 1 will be a
single-arm study of intratumoral tavokinogene telseplasmid (TAVO) plus electroporation (EP)
in combination with pembrolizumab therapy. Cohort 2 will be a single-arm study of
intratumoral TAVO-EP plus pembrolizumab along with treatment of an approved chemotherapy per
standard of care (either nab-paclitaxel (Abraxane®) or gemcitabine (Gemzar®) plus carboplatin
(Paraplatin®)) in participants with TNBC and no prior systemic therapy in the advanced or
metastatic setting will be enrolled in this study.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors
Not Recruiting
More
Avelumab in combination with talazoparib will be investigated in patients with locally
advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung
cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast
cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration
resistant prostate cancer (CRPC).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
Not Recruiting
More
The primary objective of the study is to assess the progression-free survival (PFS) of oral
veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared
to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and
locally recurrent or metastatic breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei-Jen Chang, 6507250866.
Stanford Investigators
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A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
Not Recruiting
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This is a global Phase III, double-blind, randomized, placebo-controlled study designed to
evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed
death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and
cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery
with initial clinically assessed triple-negative breast cancer (TNBC).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Not Recruiting
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This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to
evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand
1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in
combination with paclitaxel in participants with previously untreated, inoperable locally
advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1
ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or
unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40
months). In addition, the Sponsor may decide to terminate the study at any time.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors.
Not Recruiting
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This research study is designed to evaluate an experimental drug, MEDI4276, in treating
breast and stomach (gastric) cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer
Not Recruiting
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This randomized phase III trial studies how well pembrolizumab works in treating patients
with triple-negative breast cancer. Immunotherapy with monoclonal antibodies, such as
pembrolizumab, may help the body's immune system attack the cancer, and may interfere with
the ability of tumor cells to grow and spread.
Stanford is currently not accepting patients for this trial.
For more information, please contact Melinda L. Telli, 650-498-7061.
Stanford Investigators
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Phase 2 Trial of Seribantumab Plus Fulvestrant in Postmenopausal Women With Metastatic Breast Cancer
Not Recruiting
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This study is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study in
postmenopausal women with heregulin positive, hormone receptor positive, HER2 negative
metastatic, unresectable breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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PALbociclib CoLlaborative Adjuvant Study
Not Recruiting
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This is a prospective, two arm, international, multicenter, randomized, open-label Phase III
study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine
therapy for patients with HR+ / HER2- early breast cancer (EBC).
The purpose of the PALLAS study is to determine whether the addition of palbociclib to
adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2-
early breast cancer. Assessment of a variety of correlative analysis, including evaluation of
the effect of palbociclib in genomically defined tumor subgroups, is planned.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer
Not Recruiting
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This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with
niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative
breast cancer or recurrent ovarian cancer. (KEYNOTE-162)
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer
Not Recruiting
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Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in
subjects with advanced melanoma or metastatic TNBC
Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination
Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors
(CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune
systems in those subjects who have failed 1st line therapy
The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12
subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC)
subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in
Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting
dose is 4 mg/kg for Imprime PGG. In the event there are a total of > 4 (or > 33%) of subjects
with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced to 2 mg/kg,
and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of n=12 subjects.
For the dose that meets the safety criterion in Stage 1, at least 1 response in melanoma
subjects and 2 responses in TNBC subjects amongst the 12 subjects within each tumor type must
be observed in order to proceed to Stage 2.
Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For
the dose that meets the Stage 1 safety criterion, success will be declared if at least 4
amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42
subjects with TNBC achieve an objective response.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
Not Recruiting
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This randomized phase III trial studies how well doxorubicin hydrochloride and
cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients
with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin
hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop
the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and
cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and
carboplatin in treating triple-negative breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Amy Isaacson, 650-723-0501.
Stanford Investigators
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A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors
Not Recruiting
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This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in
combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid
tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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18F-FSPG PET/CT for Cancer Patients on Therapy
Not Recruiting
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The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG
used before and after treatment to diagnose, predict, and evaluate response to therapy in
patients with a wide variety of metastatic cancers.
Stanford is currently not accepting patients for this trial.
For more information, please contact Phuong Pham, 650-725-9810.
Stanford Investigators
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A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
Not Recruiting
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The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and
efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice
in patients who have locally advanced and/or metastatic breast cancer with germline BRCA
mutations.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery
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The PENELOPEB study is designed to demonstrate that, in the background of standard
anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS)
compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early
breast cancer at high risk of relapse after showing less than pathological complete response
to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in
patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an
attractive option with a favourable safety profile for these patients.
Stanford is currently not accepting patients for this trial.
For more information, please contact Amy Isaacson, 650-723-0501.
Stanford Investigators
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A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
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To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients
with advanced solid tumors in order to determine the maximum tolerated dose and select the
recommended Phase 2 dose.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors
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The aim of this single-arm phase 2 clinical trial is to evaluate the anti-cancer activity of
Talazoparib (also known as BMN 673) in patients with advanced breast cancer with specific
genetic or tumor genomic alterations. Patients with either triple-negative or HER2-negative
breast cancer are eligible.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei Jen Chang, 650-725-0866.
Stanford Investigators
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Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBC
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Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to
approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or
subcutaneous disease. Patients will receive one complete cycle of therapy, consisting of
local injection of plasmid IL-12 (pIL-12) followed immediately by electroporation (EP), into
accessible tumor lesions. IT-pIL12-EP will be administered in Days 1, 5, and 8 of the single
28-day cycle.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei Jen Chang, 650-725-0866.
Stanford Investigators
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A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
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This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety
of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination
with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth
(HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and
anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a
dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg)
intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at
a dose of 420 mg IV q3w in combination with a taxane.
Stanford is currently not accepting patients for this trial.
For more information, please contact Annabel Castaneda, 650-498-7977.
Stanford Investigators
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A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)
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The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of
talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast
cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to
either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:
- Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for
metastatic disease with disease progression > 8 weeks following the last dose of
platinum; or
- Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic
disease and who have had no prior platinum therapy for metastatic disease
Stanford is currently not accepting patients for this trial.
For more information, please contact Karen Lau, 650-723-0658.
Stanford Investigators
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M6620 First in Human Study
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An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of
M6620 in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
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The main purpose of this study is to compare progression-free survival for women with hormone
receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced
breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants
will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9
months for each participant.
For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.
Stanford is currently not accepting patients for this trial.
For more information, please contact Annabel Castaneda, 650-498-7977.
Stanford Investigators
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Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
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Many tumor cells, in contrast to normal cells, have been shown to require the amino acid
glutamine to produce energy for growth and survival. To exploit the dependence of tumors on
glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine
utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors.
This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid
tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling
patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839
capsules orally twice or three times daily.
In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative
Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)
Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase
(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H)
tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation
tumors.
As an extension of Parts 1 & 2, patients will be treated with CB-839 in combination with
standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo.
Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and
CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with
everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M
EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring
KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with
histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated
with cabozantinib in combination with CB-839.
All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),
pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may
predict responsiveness in later studies), and tumor response.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei-Jen Chang, 650-725-0866.
Stanford Investigators
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Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI
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Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant
to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with
Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).
Fulvestrant has demonstrated activity when used as first, second, or third line endocrine
therapy, making it an attractive therapy for combination with other agents. In addition, it
is commonly reserved for use following disease progression on AI therapy.
Everolimus is an orally administered drug that blocks a signaling pathway called "mTOR".
"mTOR" acts as a regulator for many processes in the body, including cell growth. Blocking
this pathway may have an effect on cell growth.
The combination of a novel class of agents (mTOR inhibitors) and an established standard
treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by
targeting multiple different biological pathways.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei-Jen Chang, 650-725-0866.
Stanford Investigators
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18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
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The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer
patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study
participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell
carcinoma (RCC) who are receiving antiangiogenesis treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact CCTO, 650-498-7061.
Stanford Investigators
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Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
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Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative
primary breast cancer who have completed definitive local treatment and neoadjuvant or
adjuvant chemotherapy
Stanford is currently not accepting patients for this trial.
For more information, please contact Amy Isaacson, 650-723-0501.
Stanford Investigators
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Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
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This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how
HER2 mutated cancer responds to treatment with neratinib.
Stanford is currently not accepting patients for this trial.
For more information, please contact Karen Lau, 650-723-0658.
Stanford Investigators
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Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
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This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab
with estrogen deprivation to see how they work compared to docetaxel, carboplatin,
trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone
receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer
that is operable or has spread from where it started to nearby tissue or lymph nodes (locally
advanced). Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and
pertuzumab, work in different ways to stop the growth of tumor cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading. Giving more than
one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth
of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition
therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation
therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and
radiation therapy with or without hormone therapy may be an effective treatment for hormone
receptor-positive, HER2-positive, operable or locally advanced breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Amy Isaacson, 650-723-0501.
Stanford Investigators
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A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
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A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of
PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts
response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety
profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD
(pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx)
expression profile in tumor samples.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei-Jen Chang, 650-725-0866.
Stanford Investigators
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Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Not Recruiting
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This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole,
letrozole, or exemestane with or without chemotherapy work in treating patients with breast
cancer that has spread from where it began in the breast to surrounding normal tissue
(invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using
tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor
cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast
cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in
different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. It is not yet known whether giving
tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination
chemotherapy in treating patients with breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Amy Isaacson, 650-723-0501.
Stanford Investigators
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A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer
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This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of
veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant
chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei Jen Chang, 650-725-0866.
Stanford Investigators
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