Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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. It is not yet known whether giving combination chemotherapy together with or without bevacizumab is more effective in treating patients with nonmetastatic breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy works compared with giving combination chemotherapy together with bevacizumab in treating patients with nonmetastatic breast cancer.

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Detailed Description

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OBJECTIVES:

Primary

* To compare the efficacy of neoadjuvant therapy comprising docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide with versus without bevacizumab in patients with HER2-negative nonmetastatic breast cancer.

Secondary

* To assess quality of life of female patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 50 years old vs \> 50 years old), estrogen receptor status (negative \[Allred score 0-2\] vs weakly positive \[Allred score 3-5\] vs strongly positive \[Allred score 6-8\]), total tumor size\* (≤ 50 mm vs \> 50 mm), clinical involvement of axillary nodes (yes vs no), and inflammatory/locally advanced disease (T4) (yes vs no). Patients are randomized to 1 of 2 treatment arms.

NOTE: \*In cases with multifocal disease in one breast, or bilateral disease, the size to be used for the stratification is the sum of the single largest diameter of all measurable tumors.

* Arm I: Patients receive docetaxel IV on day 1; treatment repeats every 3 weeks for 3 courses. Patients then receive fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1 (FEC). Treatment with fluorouracil, epirubicin hydrochloride, and cyclophosphamide repeats every 3 weeks for 3 courses.
* Arm II: Patients receive bevacizumab IV over 30 to 90 minutes and docetaxel IV on day 1; treatment repeats every 3 weeks for 3 courses. Patients then receive FEC as in arm I. Treatment with FEC repeats every 3 weeks for 3 courses. Patients also receive bevacizumab IV over 30 to 90 minutes and docetaxel IV on day 1 in FEC course 1 only.

Within 3-6 weeks after completion of last dose of study therapy, patients in both arms undergo surgery. Within 4-8 weeks after surgery, patients undergo radiotherapy according to standard protocol.

Women complete quality-of-life questionnaires (FACT-B and EuroQoL) at baseline and during and after completion of study treatment.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

Conditions

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Breast Cancer Cardiac Toxicity Perioperative/Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bevacizumab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

docetaxel

Intervention Type DRUG

epirubicin hydrochloride

Intervention Type DRUG

fluorouracil

Intervention Type DRUG

assessment of therapy complications

Intervention Type PROCEDURE

neoadjuvant therapy

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

therapeutic conventional surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* No other previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast treated by surgery only and disease-free for 10 years
* No concurrent medical or psychiatric problem that might prevent completion of treatment or follow-up
* No presence of active uncontrolled infection
* No history of nephritic or nephrotic syndrome
* No traumatic injury within the past 28 days
* No evidence of other disease that, in the opinion of the investigator, places the patient at high risk of treatment-related complications
* No nonhealing wound, peptic ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

* No prior neoadjuvant endocrine therapy
* No prior chemotherapy or radiotherapy
* No major surgical procedure within the past 28 days
* No concurrent full therapeutic dose of anticoagulants or aspirin \> 325 mg/day, clopidogrel \> 75 mg/day, or corticosteroids

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No