Phase 2 N=56 Treatment

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00559845 ↗

Enrolled (actual)

Serious AEs

14.8%

Results posted

Apr 2018

Primary outcome: Primary: Percentage of Participants With Pathological Complete Response Following Principle Investigator Review — 23.2 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 5-fluorouracil (Drug); Epidoxorubicin (Drug); Cyclophosphamide (Drug); Paclitaxel (Drug); Bevacizumab (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Hoffmann-La Roche
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Pathological Complete Response Following Principle Investigator Review	23.2	—
SECONDARY Objective Response Rate	59.0	—
SECONDARY Percentage of Participants With Breast-Conserving Surgery	17.0; 13.2	—
SECONDARY Percentage of Participants With Disease-Free Interval	92.2; 84.3; 80.4; 76.5; 76.5	—
SECONDARY Overall Survival	—	—
SECONDARY Percentage of Participants Experiencing Any Adverse Event	100.0	—

Summary

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00559845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.