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A Study of Bevacizumab Added to Trastuzumab Plus Docetaxel in the Neoadjuvant Setting in Participants With Early Stage HER2-Positive Breast Cancer (AVATAXHER)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01142778
First received: June 10, 2010
Last updated: July 20, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Bevacizumab Drug: Docetaxel Drug: Trastuzumab Procedure: Surgery Radiation: Radiotherapy Drug: Hormonal Therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Multicenter, Phase II, Non Comparative, Exploratory Study on Neoadjuvant Treatment With Trastuzumab Plus Docetaxel Plus Bevacizumab According to Positon Emission Tomography (PET) Value Modification in Patients With Early Stage HER2 Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 152
Actual Study Start Date: May 19, 2010
Estimated Study Completion Date: January 31, 2018
Estimated Primary Completion Date: January 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab, Docetaxel, and Bevacizumab
Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of <70% will receive trastuzumab and docetaxel along with bevacizumab in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the bevacizumab infusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment.
Drug: Bevacizumab
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).
Other Name: Avastin
Drug: Docetaxel
Docetaxel at a dose of 100 mg/m^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days).
Other Name: Taxotere
Drug: Trastuzumab
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).
Other Name: Herceptin
Procedure: Surgery
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).
Radiation: Radiotherapy
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.
Drug: Hormonal Therapy
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.
Active Comparator: Trastuzumab and Docetaxel
Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of <70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment.
Drug: Docetaxel
Docetaxel at a dose of 100 mg/m^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days).
Other Name: Taxotere
Drug: Trastuzumab
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).
Other Name: Herceptin
Procedure: Surgery
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).
Radiation: Radiotherapy
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.
Drug: Hormonal Therapy
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.
Active Comparator: Trastuzumab and Docetaxel (Standard Regimen)
Participants will receive 2 cycles of trastuzumab and docetaxel once every 3 weeks. Then, participants with a response of >/=70% will receive trastuzumab and docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery after Cycle 7 and between 4 and 6 weeks after the study treatment perfusion in Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy with or without hormonal therapy as per site's standard practice, and will be followed for up to 5 years from start of neoadjuvant treatment.
Drug: Docetaxel
Docetaxel at a dose of 100 mg/m^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days).
Other Name: Taxotere
Drug: Trastuzumab
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).
Other Name: Herceptin
Procedure: Surgery
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).
Radiation: Radiotherapy
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.
Drug: Hormonal Therapy
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with early stage HER2-positive breast cancer
  • Scheduled to receive neoadjuvant therapy with the objective of conservative surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Exclusion Criteria:

  • Participants with partial or total lobular carcinoma
  • Participants with inflammatory breast cancer
  • Previous treatment with chemotherapy, radiation therapy or hormonal therapy for breast cancer
  • Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in situ carcinoma of the cervix) relapsing within the 5 years before study entry or in situ contralateral breast carcinoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142778

Locations
France
Centre Radiotherapie Marie Curie
Arras, France, 62000
Centre Hospitalier; Hematologie-Oncologie
Beauvais, France, 60021
Clinique Tivoli; Sce Radiotherapie
Bordeaux, France, 33000
Hopital Augustin Morvan; Federation De Cancerologie
Brest, France, 29200
Centre Jean Perrin; Hopital De Jour
Clermont Ferrand, France, 63011
Pole Sante Republique;Oncologie Hematologie
Clermont Ferrand, France, 63050
Centre Georges Francois Leclerc; Oncologie 3
Dijon, France, 21079
Institut Daniel Hollard
Grenoble, France, 38000
CH Dptal Les Oudairies; Hematologie Oncologie
La Roche Sur Yon, France, 85925
Hopital Dupuytren; Oncologie Medicale
Limoges, France, 87042
Centre Leon Berard; Oncologie Genetique
Lyon, France, 69373
Hopital Clinique Claude Bernard; Oncologie Medicale
Metz, France, 57000
Ch De Montlucon; Sce Med Interne Hemato Onco
Montlucon, France, 03100
Institut régional du Cancer Montpellier
Montpellier, France, 34298
Centre D'Oncologie de Gentilly; Oncology
Nancy, France, 54100
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, France, 06189
Institut Curie; Oncologie Medicale
Paris, France, 75231
GH Paris Saint Joseph; Hopital De Jour Oncologie
Paris, France, 75674
HOPITAL TENON; Cancerologie Medicale
Paris, France, 75970
Clinique Francheville; Radiotherapie
Perigueux, France, 24000
Institut Jean Godinot; Oncologie Medicale
Reims CEDEX, France, 51056
Centre Eugene Marquis; Unite Huguenin
Rennes, France, 35042
Clinique de L'Union; Oncologie
Saint Jean, France, 31240
Institut de Cancerologie de La Loire; Radiotherapie
St Priest En Jarez, France, 42271
Centre Paul Strauss; Oncologie Medicale
Strasbourg, France, 67065
Clinique Pasteur; Oncologie Medicale
Toulouse, France, 31076
Centre Henry S Kaplan - CHU Bretonneau ; service oncologie
Tours, France, 37044
Centre Alexis Vautrin; Oncologie Medicale
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01142778     History of Changes
Other Study ID Numbers: ML22229
2009-013410-26 ( EudraCT Number )
Study First Received: June 10, 2010
Last Updated: July 20, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Docetaxel
Trastuzumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2017