Status:
COMPLETED
Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer
Lead Sponsor:
Sanofi
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-...
Detailed Description
The study included: * Study registration on Day 1: Treatment Cycle 1 was initiated within 14 days of signing informed consent * Treatment was administered in 3 week treatment cycles until the partici...
Eligibility Criteria
Inclusion
- The following information on clinical trials is provided for information purposes only to allow participants and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
- INCLUSION CRITERIA:
- Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis
- Stage IV disease with at least one measurable lesion according to the RECIST criteria
- HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors
- Life expectancy of \>/= 24 weeks
- No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).
- Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m\^2 doxorubicin or 750 mg/m\^2 epirubicin)
- At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy with complete recovery from the effects of these interventions
- It is recommended that all baseline staging should be completed within 35 days prior to study entry. All subjects will have the following workup as applicable; CT scan of brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm or exclude metastatic bone disease. Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion is measurable and can be followed by RECIST criteria. Other tests may be performed as clinically indicated
- Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) of \>/= 50% or shortening fraction (multiple-gated acquisition \[MUGA\] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.
- Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started within \<2 months prior to treatment the bone lesions will not be evaluated for response, and the subjects must have another site of metastatic disease that is either measurable or evaluable for response
- EXCLUSION CRITERIA:
- Prior chemotherapy for metastatic breast cancer
- Prior treatment with bevacizumab or other anti-VEGF therapy
- Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy
- Current or prior history of brain or leptomeningeal metastases
- Presence of neuropathy \>/= 2
- Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (\>/= Grade 2) peripheral vascular disease
- History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix
- Clinically significant cardiovascular disease
- Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy
- History of bleeding diathesis or coagulopathy
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00364611
Start Date
August 1 2006
End Date
April 1 2012
Last Update
August 23 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807