Stanford APBI Trial
Clinical Trial
Overview
Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.
Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.
Currently, women with breast cancer who undergo a lumpectomy typically have 6 1/2 weeks of radiation to the entire affected breast after surgery. Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.
In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.
APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.
Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:
Intraoperative Radiotherapy (IORT) - 1 day
Intracavitary Brachytherapy (MammoSite) - 5 days
3-D Conformal/External Beam Radiotherapy - 5 days
The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.
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
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.
Stanford Investigator(s):
Intervention(s):
- drug: Niraparib
- drug: Placebo
Eligibility
Inclusion Criteria:
- Stage I to III breast cancer with surgical resection of the primary tumor that is
confirmed to be either: TNBC, irrespective of BRCA status or HR+/HER2- breast cancer
with a known and documented deleterious or suspected deleterious tBRCA mutation.
- Estrogen receptor (ER) and/or progesterone receptor (PgR) negativity is defined as
immunohistochemistry (IHC) nuclear staining less than (<) 1 percentage (%), or by
Allred scoring system where TNBC is defined to be 0 out of 8 or 2 out of 8, or
staining in <1 % of cancer cells.
- Completed prior standard therapy for curative intent.
- Participants with HR+ breast cancer must be on a stable regimen of endocrine therapy.
- Detectable ctDNA as measured by central testing.
- An archival tumor tissue specimen of the primary tumor sufficient in quality and
quantity for ctDNA assay design and tBRCA and Homologous recombination deficiency
(HRD) testing is required.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
- Prior treatment with a Poly Adenosine-diphosphate Ribose Polymerase (PARP) inhibitor.
- Current treatment with a Cyclin-dependent kinase (CDK)4/6 inhibitor or endocrine
therapy other than anastrozole, letrozole, exemestane, and tamoxifen with or without
ovarian suppression.
- Participants have any sign of metastasis or local recurrence after comprehensive
assessment conducted per protocol.
- Participants have shown no definitive response to preoperative chemotherapy by
pathologic, radiographic or clinical evaluation, in cases where preoperative
chemotherapy was administered.
- Participants have inadequately treated or controlled hypertension.
- Participants have received live vaccine within 30 days of planned start of study
randomization.
- Participants have a second primary malignancy.
- Exceptions are the following: (a) Adequately treated non-melanoma skin cancer,
curatively treated in situ cancer of the cervix, Ductal carcinoma in situ (DCIS) of
the breast, Stage I Grade 1 endometrial carcinoma. (b) Other solid tumors and
lymphomas (without bone marrow involvement) diagnosed >=5 years prior to randomization
and treated with no evidence of disease recurrence and for whom no more than 1 line of
chemotherapy was applied.
- Participant is pregnant, breastfeeding, or expecting to conceive children while
receiving study treatment and/or for up to 180 days after the last dose of study
treatment (except France).
- Participant is immunocompromised. Participants with splenectomy are allowed.
Participants with known human immunodeficiency virus (HIV) are allowed if they meet
protocol-defined criteria.
- Participants have a known history of myelodysplastic syndrome (MDS) or acute myeloid
leukemia (AML).
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kaushali Anant Thakore-Shah
+1 650-721-6977
Not Recruiting
What's New
Stanford’s APBI trial has now been expanded to include women with ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.