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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00391092

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 locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Bevacizumab Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment:	410
Study Start Date:	September 2006
Estimated Study Completion Date:	August 2011

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 15mg/kg iv every 3 weeks Drug: Herceptin 8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks Drug: Docetaxel 100mg/m2 iv every 3 weeks
2: Active Comparator	Drug: Herceptin 8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks Drug: Docetaxel 100mg/m2 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391092

Contacts

Contact: Please reference Study ID Number: BO20231	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 83 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BO20231
Study First Received:	October 20, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00391092
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Trastuzumab
Disease Progression

Breast Neoplasms
Bevacizumab
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009