An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 52
- Primary Endpoint
- Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Intervention: Standard chemotherapy (Drug)
1
Intervention: bevacizumab [Avastin] (Drug)
1
Intervention: trastuzumab [Herceptin] (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification
Time Frame: From baseline through Week 25 (Up to 6 months)
PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than \[\>\] 50 percent \[%\] therapeutic effect but less than \[\<\] T-A), T-C (\<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.
Secondary Outcomes
- Percentage of Participants With a PCR According to the Chevallier Classification(From baseline through Week 25 (Up to 6 months))
- Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit(Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25))
- Percentage of Participants Who Underwent Lymph Node Resection(Anytime between Week 26 and Week 29)
- Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit(Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25))
- Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit(Baseline, Neoadjuvant Final Visit (Week 25))
- Number of Participants Who Underwent Mastectomy(Anytime between Week 26 and Week 29)
- Percentage of Participants With Macroscopically Visible Tumor(Anytime between Week 26 and Week 29)
- Percentage of Participants Who Were Disease Free at 3 and 5 Years(3, 5 years)
- Disease Free Survival (DFS) Duration(Up to 5 Years)
- Percentage of Participants Who Were Recurrence Free at 3 and 5 Years(3, 5 years)
- Recurrence Free Survival (RFS) Duration(Up to 5 Years)
- Percentage of Participants Who Were Alive at 3 and 5 Years(3, 5 years)
- Overall Survival (OS) Duration(Up to 5 years)