This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel once every 3 weeks, participants with a response (change in standard uptake value \[SUV\]) of less than (\<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a 2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram \[mg/kg\]) and docetaxel (100 milligrams per square meter \[mg/m\^2\]) with or without bevacizumab (15 mg/kg). Participants with a response of greater than or equal to (\>/=) 70% will receive trastuzumab plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery during 4-6 weeks, according to site's standard practice) with or without hormonal therapy (mandatory if positive hormone receptors). Participants will be followed for up to 5 years from start of neoadjuvant treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Bevacizumab at a dose of 15 mg/kg will be administered as IV infusion over 90 minutes from Cycles 3-6 (1 Cycle=21 days).
Docetaxel at a dose of 100 mg/m\^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days).
Trastuzumab will be administered as a loading dose of 8 mg/kg as IV infusion in Cycle 1, followed by subsequent dose of 6 mg/kg as IV infusion in Cycles 2 to 7, and during additional 11 cycles post surgery (1 Cycle=21 days).
All participants will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the study treatment infusion in Cycle 6 (1 Cycle=21 days).
All participants will receive radiotherapy starting about 4 to 8 weeks after surgery, and will last around 4 to 6 weeks as per site's standard practice.
Participants who are hormone receptors positive, will receive hormonal therapy after completion of radio therapy period as per investigator's discretion and site's standard practice.
Centre Radiotherapie Marie Curie
Arras, France
Centre Hospitalier; Hematologie-Oncologie
Beauvais, France
Clinique Tivoli; Sce Radiotherapie
Bordeaux, France
Hopital Augustin Morvan; Federation De Cancerologie
Brest, France
Centre Jean Perrin; Hopital De Jour
Clermont-Ferrand, France
Pole Sante Republique;Oncologie Hematologie
Percentage of Participants With Pathological Complete Response as per Chevallier's Classification as Reviewed by an Independent Committee
Time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Percentage of Participants With Pathological Complete Response According to Chevallier's Classification as per Local Procedures
Time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Percentage of Participants With Pathological Complete Response According to Sataloff's Classification as Reviewed by an Independent Committee
Time frame: After 6 cycles (18 weeks) of neoadjuvant therapy (cycle length=21 days)
Percentage of Participants With Ultrasound Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Neodajuvant treatment period (21 weeks)
Percentage of Participants With Conservative Surgery Post Neoadjuvant Treatment
Time frame: Week 20 (between Day 28 and Day 35 after the Cycle 6, cycle length=21 days)
Local Relapse-Free Interval (LRFI) According to Modified RECIST Criteria
Time frame: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Disease-Free Survival (DFS) According to Modified RECIST Criteria
Time frame: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Distant Disease-Free Interval (DDFI) According to Modified RECIST Criteria
Time frame: From baseline to occurrence of relapse/disease or death of any cause (up to 5 years)
Overall Survival
Time frame: Baseline up to occurrence of death (up to 5 years)
Percentage of Participants With Adverse Events
Time frame: Baseline up to 5 years
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Clermont-Ferrand, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, France
Institut Daniel Hollard
Grenoble, France
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, France
Hopital Dupuytren; Oncologie Medicale
Limoges, France
...and 18 more locations