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A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: 5-fluorouracil, Epidoxorubicin, Cyclophosphamide, Paclitaxel, Bevacizumab

Countries: Italy

This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* female participants, \>=18 years of age;
* stage III, or inflammatory breast cancer;
* estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
* normal left ventricular ejection fraction (LVEF).

Exclusion Criteria:

* previous chemotherapy/endocrine therapy;
* evidence of distant metastatic disease;
* other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
* chronic daily treatment with \>325 milligram per day (mg/day) aspirin, or \>75mg/day clopidogrel.

Locations (8)

Naples, Campania, Italy
Reggio Emilia, Emilia-Romagna, Italy
Pordenone, Friuli Venezia Giulia, Italy
Genoa, Liguria, Italy
Mantua, Lombardy, Italy
Cuneo, Piedmont, Italy
Turin, Piedmont, Italy
Negrar, Veneto, Italy