EUCTR2007-005828-32-AT
Active, not recruiting
Not Applicable
A randomized phase III 2-arm trial of paclitaxel plus bevacizumab vs. capecitabine plus bevacizumab for the first-line treatment of HER2-negative locally recurrent or metastatic breast cancer
CECOG0 sites560 target enrollmentMarch 11, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CECOG
- Enrollment
- 560
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Written informed consent obtained prior to any study\-specific procedure.
- •2\.Age at least 18 years.
- •3\.Able to comply with the protocol.
- •4\.Histologically or cytologically confirmed, HER2\-negative, adenocarcinoma of the breast with measurable or non\-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent.
- •5\.ECOG performance status of 0–2\.
- •6\.Life expectancy more than 12 weeks.
- •7\.Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization. However, if (neo)adjuvant chemotherapy was:
- •–Taxane\-based, patients are eligible only if they received their last taxane more than 12 months prior to randomization.
- •–Anthracycline\-based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin.
- •8\.Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that: –no more than 30% of marrow\-bearing bone was irradiated
Exclusion Criteria
- •1\.Previous chemotherapy for metastatic or locally recurrent breast cancer.
- •2\.Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 3 weeks prior to randomization.
- •3\.Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned above).
- •4\.Other primary tumors within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
- •5\.Pre\-existing peripheral neuropathy NCI CTCAE grade \> 2 at randomization.
- •6\.Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases (even if previously treated). If suspected, the patient should be scanned by CT or magnetic resonance imaging (MRI) within 28 days prior to randomization to rule out spinal / CNS metastases.
- •7\.History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
- •8\.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.
- •9\.Minor surgical procedures, including insertion of an indwelling catheter, within 24 hours prior to randomization.
- •10\.Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (\> 325 mg/day) or clopidogrel (\> 75 mg/day).
Outcomes
Primary Outcomes
Not specified
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