Robert Carlson
Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether doxorubicin, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab in treating breast cancer. PURPOSE: This randomized phase III trial is studying doxorubicin, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with lymph node-positive or high-risk, lymph node-negative breast cancer.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Vaccine: bevacizumab
- Drug: cyclophosphamide
- Drug: paclitaxel
- Drug: pegylated liposomal doxorubicin hydrochloride
- Drug: placebo
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
o Significant risk of distant recurrence based on >= 1 of the following criteria:
a. At least 1 axillary lymph node positive on routine histologic examination (must be demonstrated by more than immunohistochemistry alone)
b. Estrogen receptor (ER)-negative tumor >= 1 cm
c. ER+ tumor >= 5 cm regardless of recurrence score
d. ER+ tumor >= 1 cm but < 5 cm with a recurrence score >= 11
1. Patients enrolled on ECOG-PACCT-1 clinical trial are eligible
- Has undergone definitive breast surgery within the past 29-84 days, including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, lumpectomy and axillary dissection, or lumpectomy and sentinel node biopsy
o Surgical margins must be histologically free of invasive breast cancer and ductal carcinoma in situ
a. Resection margins positive for lobular carcinoma in situ allowed
- Planned post-lumpectomy radiation therapy required, including any of the following:
o Whole breast radiation therapy after chemotherapy
o Accelerated partial breast radiation therapy after chemotherapy
o Accelerated partial breast radiation therapy prior to chemotherapy
- Planned post-mastectomy radiation therapy required for patients with a primary tumor of > 5 cm or involvement of >= 4 lymph nodes
- No HER2/neu positive breast cancer (i.e., 3+ by immunohistochemistry or positive by fluorescent in situ hybridization [FISH])
- No clinical evidence of inflammatory disease or fixed axillary nodes (N2) at diagnosis
- May have synchronous bilateral breast cancer (diagnosed <= 1 month) if the higher TNM stage tumor meets the eligibility criteria for this trial
- Hormone receptor status known
PATIENT CHARACTERISTICS:
- Male or female
- Pre- or post-menopausal
- ECOG performance status 0-1
- Absolute neutrophil count >= 1,000/mm^3
- Platelet count >= 100,000/mm^3
- Bilirubin <= 1.5 mg/dL
- AST <= 2 times upper limit of normal (ULN)
- Creatinine <= 1.5 mg/dL
- Urine protein:creatinine ratio < 1.0
- PTT <= 1.5 times ULN
- LVEF normal by echocardiogram or MUGA
- No clinically significant cardiovascular or cerebrovascular disease, including any of the following:
o Uncontrolled arrhythmia
a. Controlled atrial fibrillation allowed
o Uncontrolled hypertension, defined as systolic blood pressure (BP) > 160 mm Hg or diastolic BP > 90 mm Hg
o Transient ischemic attack, stroke, or subarachnoid hemorrhage
o Ischemic bowel
o Myocardial infarction within the past 12 months
o Unstable angina within the past 12 months
o New York Heart Association class II-IV congestive heart failure within the past 12 months
o Peripheral vascular disease >= grade 2 within the past 12 months
- No bleeding diathesis, hereditary or acquired bleeding disorder, or coagulopathy
- No nonhealing wound or fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor EL, Chinese hamster ovary cell products, or other recombinant human antibodies
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for >= 3 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 28 days since prior major surgery
a. Nonoperative biopsy not considered major surgery
- More than 24 hours since prior placement of a vascular access device
- No prior cytotoxic chemotherapy or hormonal therapy for study cancer
a. May have received prior (but no concurrent) tamoxifen or raloxifene for chemoprevention
- No prior anthracycline, anthracenedione, or taxane for any condition
- Concurrent full-dose anticoagulation allowed provided the following criteria are met:
o INR in-range (usually between 2 and 3) on a stable dose of warfarin or low molecular weight heparin
o No active bleeding or pathological conditions that carry a high risk of bleeding (e.g., varices)
- Concurrrent prophylactic anticoagulants to maintain patency of a vascular access device allowed
- No concurrent cardioprotectant drugs
Key Exclusion Criteria:
Additional Study Details
Official Title:
A Double-Blind Phase III Trial of Doxorubicin Hydrochloride Liposome and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast CancerAnticipated start date:
1/15/2008Lead Sponsor:
Eastern Cooperative Oncology GroupCollaborator(s):
- National Cancer Institute (NCI)
- North Central Cancer Treatment Group
- Cancer and Leukemia Group B
Investigator(s):
- Robert W Carlson
- Dr. Ellie Guardino MD/PhD
- Allison Walsh Kurian
- See-Chun Phan
- Harlan Pinto
- Klaus Porzig
- Frank E. Stockdale
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Disease-free survival (DFS)
Secondary Outcomes:
- Efficacy of short-term vs long-term bevacizumab, in terms of DFS
- Overall survival
Total Number to be Enrolled:
4950Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- 98613
- CDR0000528955
- ECOG-E5103
- ECOGE5103
- NCT00433511
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/20/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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