Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: 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. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Bevacizumab; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed inflammatory breast cancer, meeting 1 of the following staging criteria:

• T4d, any N (AJCC stage IIIB or IIIC)

• Gustave-Roussy Institute (IGR) classification Poussee evolutirie (PEV; measures tumor growth over time) 2

• PEV 2: tumor with underlying breast tissue, especially skin, that is affected by subacute inflammation and edema involving < ½ of breast surface

• IGR classification PEV 3

• PEV 3: acute or subacute inflammation and edema involving > ½ of breast surface

• Biopsy-confirmed presence of tumor embolism in surface lymph nodes

• HER2-negative (HER2 0 or 1+, or HER2 2+ by IHC if FISH-negative allowed)

• No metastatic disease

• No non-inflammatory breast cancer with edema, ulceration, or satellite skin nodules

• No bilateral breast cancer

• Hormone receptor status known

PATIENT CHARACTERISTICS:

• Any menopausal status allowed

• WHO performance status 0-2

• Life expectancy ≥3 months

• LVEF normal by ECHO

• ANC >1.5 x 10^9/L

• Platelet count >100 x 10^9/L

• INR ≤1.5 (except for patients on prophylactic anticoagulants)

• aPTT ≤1.5 times upper limit of normal (ULN)

• Total bilirubin normal

• SGOT and SGPT ≤1.25 times ULN

• Alkaline phosphatase ≤2.5 times ULN

• Creatinine clearance ≥60 mL/min

• Proteinuria <2+ or 24-hour urine protein ≤1 g

• No unhealed wound, stomach ulcer, or bone fracture

• No history of thrombotic or hemorrhagic disorders

• No significant cardiovascular disease including the following:

• Cerebrovascular accident within the past 6 months

• Unstable angina

• Cardiac failure

• Myocardial infarction

• Arrhythmia requiring treatment

• No uncontrolled hypertension (i.e., systolic BP >150 mm Hg and/or diastolic BP >100 mm Hg)

• No other active infection or serious illness that would preclude patient from receiving study treatment

• No hypersensitivity to any active products or excipients of study drugs

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 6 months after completion of study treatment

• No social or psychologic reasons that would prevent study compliance or follow-up

• No patients who are incarcerated or on probation

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy, radiotherapy, or hormonal therapy for this disease

• More than 4 weeks since prior surgery (diagnostic biopsy or installation of implant allowed)

• More than 10 days since prior chronic non-inflammatory steroids (e.g., acetylsalicylic acid >325 mg/day) or platelet anticoagulation treatment (e.g., dipyridamole, ticlopidine, clodiprogel, cilostazol)

• More than 10 days since prior oral or parenteral anticoagulant or thrombolytic drugs (preventative thrombolytic drugs allowed)

• No concurrent participation in another experimental clinical trial