Clinical trial
Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without…
NCT00005970 · National Cancer Institute (NCI), NIH · Completed
Key facts
| NCT number | NCT00005970 |
|---|---|
| Title | Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer |
| Official title | Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer |
| Lead sponsor | National Cancer Institute (NCI), NIH |
| Collaborators | Cancer and Leukemia Group B Eastern Cooperative Oncology Group Canadian Cancer Trials Group SWOG Cancer Research Network |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Breast Adenocarcinoma, HER2 Positive Breast Carcinoma, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7 |
| Intervention type | Biological, Drug, Other |
| Interventions | Aromatase Inhibition Therapy, Cyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel, Tamoxifen Citrate, Trastuzumab |
| Enrollment | 3,436 |
| Start date | May 19, 2000 |
| Primary completion | Apr 25, 2005 |
| Completion | Jan 27, 2010 |
| First posted | Jan 27, 2003 |
| Last update posted | Aug 14, 2020 |
| Countries | Canada, Peru, South Africa, United States |
At a glance
- 100–999 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: