Phase 2
Completed N=52
A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.
Source: ClinicalTrials.gov NCT00717405 ↗Enrolled (actual)
52
Serious AEs
38.5%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification — 63.46 percentage of participants
Summary
This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification |
63.46 | — |
| SECONDARY Percentage of Participants With a PCR According to the Chevallier Classification |
53.85 | — |
| SECONDARY Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit |
88.4; 100.0 | — |
| SECONDARY Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit |
90.9; 97.8 | — |
| SECONDARY Number of Participants Who Underwent Mastectomy |
49 | — |
| SECONDARY Percentage of Participants With Macroscopically Visible Tumor |
26.5 | — |
| SECONDARY Percentage of Participants Who Underwent Lymph Node Resection |
98.0 | — |
| SECONDARY Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit |
39.66; 29.39; -3.39 | — |
| SECONDARY Percentage of Participants Who Were Disease Free at 3 and 5 Years |
66.7; 60.8 | — |
| SECONDARY Disease Free Survival (DFS) Duration |
NA | — |
| SECONDARY Percentage of Participants Who Were Recurrence Free at 3 and 5 Years |
69.7; 65.4 | — |
| SECONDARY Recurrence Free Survival (RFS) Duration |
NA | — |
| SECONDARY Percentage of Participants Who Were Alive at 3 and 5 Years |
90.0; 81.8 | — |
| SECONDARY Overall Survival (OS) Duration |
NA | — |
Eligibility Criteria
Inclusion Criteria
- adult females, >=18 years of age;
- inflammatory breast cancer;
- HER2-positive tumors;
- performance status 0-2.
Exclusion Criteria
- metastases;
- previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;
- clinically significant cardiovascular disease, or history of thrombotic disorders.
Data sourced from ClinicalTrials.gov (NCT00717405). 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. Informational only — not medical advice.