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Sponsors and Collaborators: |
Breast International Group European Organization for Research and Treatment of Cancer National Cancer Institute of Canada International Breast Cancer Study Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045032 |
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether trastuzumab is effective in treating primary breast cancer in women who have completed adjuvant chemotherapy.
PURPOSE: This randomized phase III trial is studying two different regimens of trastuzumab and observation only to compare how well they work in treating women with breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: trastuzumab Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | HERA: A Randomised Three-Arm Multi-Centre Comparison Of 1 Year And 2 Years Of Herceptin Versus No Herceptin In Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy |
Study Start Date: | December 2001 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to nodal status (any nodal status and prior neoadjuvant chemotherapy vs no positive nodes and no prior neoadjuvant chemotherapy vs 1-3 positive nodes and no prior neoadjuvant chemotherapy vs 4 or more positive nodes and no prior neoadjuvant chemotherapy), prior adjuvant chemotherapy regimen (no anthracyclines or taxanes vs anthracyclines only vs anthracyclines and taxanes), receptor status and endocrine therapy (negative vs positive and no prior endocrine therapy vs positive and prior endocrine therapy), age (18 to 34 vs 35 to 49 vs 50 to 59 vs 60 and over), and participating center. Patients are randomized to 1 of 3 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 4,482 patients (1,494 per treatment arm) will be accrued for this study within 4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed nonmetastatic primary invasive adenocarcinoma of the breast
HER2-positive disease with one of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
Study Chair: | Robert E. Coleman, MD, FRCP | Cancer Research Centre at Weston Park Hospital |
Study Chair: | Karen A. Gelmon, MD | British Columbia Cancer Agency |
Investigator: | Kathleen I. Pritchard, MD | Edmond Odette Cancer Centre at Sunnybrook |
Study Chair: | Olivia Pagani, MD | Ospedale Beata Vergine |
Study ID Numbers: | CDR0000256320, BIG-01-01, EU-20216, ROCHE-B016348E, ROCHE-B016348C, EORTC-10011, CAN-NCIC-MA24, IBCSG-28-02 |
Study First Received: | September 6, 2002 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00045032 History of Changes |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Adjuvants, Immunologic Trastuzumab Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Trastuzumab Breast Neoplasms Pharmacologic Actions Breast Diseases |