Clinical trial
Combination Chemotherapy, Surgery, and Radiation Therapy With or Without…
NCT00016276 · National Cancer Institute (NCI), NIH · Terminated
Key facts
| NCT number | NCT00016276 |
|---|---|
| Title | Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer |
| Official title | A 2X2X2 Factorial Randomized Phase III Trial Of Multimodality Therapy Comparing 4 Cycles Of Doxorubicin And Cyclophosphamide With Or Without Dexrazoxane (AC+/-Z) Followed By 12 Weeks Of Weekly Paclitaxel With Or Without Trastuzumab (T+/-H) Followed By Local Therapy Followed By 40 Weeks Of Weekly… |
| Lead sponsor | National Cancer Institute (NCI), NIH |
| Status | Terminated |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Cardiac Toxicity, Inflammatory Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer |
| Intervention type | Biological, Drug, Other, Procedure, Radiation |
| Interventions | dexrazoxane hydrochloride, doxorubicin hydrochloride, cyclophosphamide, paclitaxel, trastuzumab, therapeutic conventional surgery, radiation therapy, tamoxifen citrate, laboratory biomarker analysis |
| Enrollment | 396 |
| Start date | May 1, 2001 |
| Primary completion | Mar 1, 2005 |
| First posted | Sep 4, 2003 |
| Last update posted | Jan 16, 2013 |
| Countries | United States |
At a glance
- 1–9 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.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: