Clinical trial NCT00717405: A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification
timeFrame: From baseline through Week 25 (Up to 6 months)
Secondary outcomes:
measure: Percentage of Participants With a PCR According to the Chevallier Classification
timeFrame: From baseline through Week 25 (Up to 6 months)
measure: Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit
timeFrame: Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)
measure: Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit
timeFrame: Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)
measure: Number of Participants Who Underwent Mastectomy
timeFrame: Anytime between Week 26 and Week 29
measure: Percentage of Participants With Macroscopically Visible Tumor
timeFrame: Anytime between Week 26 and Week 29
measure: Percentage of Participants Who Underwent Lymph Node Resection
timeFrame: Anytime between Week 26 and Week 29
measure: Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit
timeFrame: Baseline, Neoadjuvant Final Visit (Week 25)
measure: Percentage of Participants Who Were Disease Free at 3 and 5 Years
timeFrame: 3, 5 years
measure: Disease Free Survival (DFS) Duration
timeFrame: Up to 5 Years
measure: Percentage of Participants Who Were Recurrence Free at 3 and 5 Years
timeFrame: 3, 5 years
measure: Recurrence Free Survival (RFS) Duration
timeFrame: Up to 5 Years
measure: Percentage of Participants Who Were Alive at 3 and 5 Years
timeFrame: 3, 5 years
measure: Overall Survival (OS) Duration
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Besancon
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Caen
country: France
city: Clermont Ferrand
country: France
city: Dijon
country: France
city: La Tronche
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Reims CEDEX
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint Brieuc
country: France
city: Saint Herblain
country: France
city: St Cloud
country: France
city: St Priest En Jarez
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Vandoeuvre Les Nancy
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Pierga JY, Petit T, Delozier T, Ferrero JM, Campone M, Gligorov J, Lerebours F, Roche H, Bachelot T, Charafe-Jauffret E, Pavlyuk M, Kraemer S, Bidard FC, Viens P. Neoadjuvant bevacizumab, trastuzumab, and chemotherapy for primary inflammatory HER2-positive breast cancer (BEVERLY-2): an open-label, single-arm phase 2 study. Lancet Oncol. 2012 Apr;13(4):375-84. doi: 10.1016/S1470-2045(12)70049-9. Epub 2012 Feb 28.