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A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00391092
First received: October 20, 2006
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/ docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive loca lly recurrent or metastatic breast cancer who have not received prior chemothera py for their metastatic disease. Patients will be randomized 1:1 to receive eith er Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg i v q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxe l alone. The anticipated time on study treatment is until disease progression, a nd the target sample size is 100-500 individuals.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: Docetaxel
Drug: Herceptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: (36 months after randomization of last patient) ] [ Designated as safety issue: No ]
  • Best overall response, duration of response, time to treatment failure. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • QoL, AEs, targeted events including CHF, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 424
Study Start Date: September 2006
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Drug: Docetaxel
100mg/m2 iv every 3 weeks
Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Active Comparator: 2 Drug: Docetaxel
100mg/m2 iv every 3 weeks
Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • HER2 positive breast cancer with locally recurrent or metastatic lesions;
  • eligible for chemotherapy;
  • baseline LVEF >=50%.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
  • other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
  • clinically significant cardiovascular disease;
  • chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).
  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: NCT00391092

  Show 90 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00391092     History of Changes
Other Study ID Numbers: BO20231
Study First Received: October 20, 2006
Last Updated: November 3, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on November 19, 2014