Study:
Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing Node Positive or High-Risk Node Negative Breast Cancer
Rationale:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. 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 combination chemotherapy is more effective with or
without trastuzumab in treating breast cancer.
Purpose:
This randomized phase III trial is studying combination chemotherapy and
trastuzumab to see how well they work compared to combination chemotherapy alone in treating
women with breast cancer.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Breast Cancer |
Biological: trastuzumab
Drug: aromatase inhibition therapy
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: tamoxifen citrate
Procedure: adjuvant therapy |
Phase 3 |
Verified by
North Central Cancer Treatment Group
January, 2006
Sponsored by: North Central Cancer Treatment Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00005970
Study Type: Interventional
Study Design: Allocation: Randomized, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195-9001
United States
Edith A. Perez, MD., Study Chair
Nancy E. Davidson, MD., Study Chair
Peter A. Kaufman, MD., Study Chair
Silvana Martino, DO., Study Chair
Karen A. Gelmon, MD., Study Chair