A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-015-09
- Lead Sponsor
- EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 0
• Patients should have histologically confirmed breast adenocarcinoma with significant risk of distant recurrence in at least one of the following criteria: Commitment of at least one axillary lymph node in the routine histological examination. Patients with axillary node involvement demonstrated only by immunohistochemistry are not eligible unless they meet one of the following eligibility criteria: Negative ER tumor> 1 cm, RE + tumor> 5 cm. regardless of recurrence score, RE + tumor> 1 cm. but <5 cm. with a recurrence score> 11. (Patients recruited in the TAILORx trial are eligible.)
• Patients should have complete definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and axillary node biopsy, breast conservation and axillary dissection surgery or breast conservation surgery and sentinel node biopsy.
• The margins of conservation surgery or mastectomy should be histologically free of invasive breast cancer or ductal carcinoma in situ (COIS). Patients with positive resection margins for lobular carcinoma in situ (CLIS) are eligible.
• The Interval between the last surgery for breast cancer (breast conservation surgery, mastectomy, sentinel node biopsy, axillary dissection or re-excision of breast conservation surgery margins) and Day 1 of treatment should be> 28 days and <84 days.
• ECOG operating status of 0-1
• Patients must have adequate organ function within <8 weeks prior to randomization.
• Patients who have undergone breast conservation surgery should receive radiation. Prior to randomization, the researcher must specify the planned radiation technique,
• Post-mastectomfa RT is required for all patients with a main tumor> 5 cm. or commitment of 4 to more lymph nodes. Post-mastectomy RT is administered at the discretion of the investigator for all patients with another mastectomy.
• Patients with synchronous bilateral breast cancer (diagnosed in the last month) are eligible if the major TMN stage tumor meets the eligibility criteria of this trial.
• Patients should not have received previous cytotoxic or hormonal chemotherapy for this breast cancer. Previous treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed.
• Patients should not have had major surgical procedures within 28 days of day 1 of treatment.
• Patients requiring full dose anticoagulation can be recruited
• Male or female patients of age> 16 years of age are eligible.
• Women with potential fertility and sexually active men should use an accepted and effective method of contraception.
• Patients with HER2 + (3+ for IHC or F1SH +) breast cancer are not eligible.
• Patients with clinical evidence of inflammatory disease or axillary nodes fixed in the diagnosis.
• Patients who have had a vascular access device within 24 hours of planned Day 1 of the protocol treatment.
• Patients with clinically significant cardiovascular or cerebrovascular disease
• Patients with bleeding diathesis, inherited or acquired bleeding disorder or coagulopathy.
• Patients who present a wound or fracture that does not heal. Patients with abdominal fistula, or intra-abdominal access at 6 months prior to randomization are not eligible.
• Patients with hypersensitivity to Paditaxel or drugs that use the Cremophor vehicle, hamster ovary cell products or other recombinant human antibodies.
• Women who are pregnant or breastfeeding due to the potential harmful effects of Bevacizumab on the developing fetus. All women with potential fertility must have a blood or urine test within 7 days prior to randomization to rule out pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Time elapsed until the first appearance of any sign or symptom related to the disease.<br>Measure:Disease-free survival<br>Timepoints:From the date of randomization to the date of first treatment failure, assessed up to 15 years<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Record of adverse events occurred during the study.<br>Measure:Incidence of adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0<br>Timepoints:Up to 30 days after completion of study treatment<br>;<br>Outcome name:The comparison between arms will be made using a stratified log rank test among all randomized patients.<br><br>Measure:Overall survival<br>Timepoints:From randomization to date of death, assessed up to 15 years<br>;<br>Outcome name:Compared between arms using a two-sided t-test. The Wilcoxon Rank Sum test will be used to compare the arms if the distributions of scores are not normally distributed. Longitudinal modeling will be used to look at changes in the scores over time across arms.<br><br>Measure:Quality of life, measured by average total score for the Functional Assessment of Cancer Therapy-Breast<br>Timepoints:Up to 18 months<br>