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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.
90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.
Unnamed facility
Naples, Campania, Italy
Unnamed facility
Reggio Emilia, Emilia-Romagna, Italy
Unnamed facility
Pordenone, Friuli Venezia Giulia, Italy
Unnamed facility
Genoa, Liguria, Italy
Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.
Time frame: Up to 7.5 years
Objective Response Rate
Objective response rate was defined as the percentage of participants with a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions; PR was defined as a 30% decrease in sum of longest diameter of target lesions.
Time frame: Up to 7.5 years
Percentage of Participants With Breast-Conserving Surgery
Rate of breast conversing surgery is defined as percentage of participants who achieved breast conversing surgery out of the ITT population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant treatment.
Time frame: Up to 7.5 years
Percentage of Participants With Disease-Free Interval
Disease-free interval was defined as the time from enrollment until recurrence of tumor or death from any cause, and was estimated using the Kaplan-Meier method. The percentage of participants without events at Months 12, 24, 36, 48, and 60 is presented.
Time frame: Months 12, 24, 36, 48, and 60
Overall Survival
Overall survival was defined as the time from enrollment of participant to death from any cause.
Time frame: Up to 7.5 years
Percentage of Participants Experiencing Any Adverse Event
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Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks.
Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.
Unnamed facility
Mantua, Lombardy, Italy
Unnamed facility
Cuneo, Piedmont, Italy
Unnamed facility
Turin, Piedmont, Italy
Unnamed facility
Negrar, Veneto, Italy
An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to 7.5 years