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NCT00005970
Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer
Phase 3 trial testing Aromatase Inhibition Therapy in Breast Adenocarcinoma in 3,436 participants. Completed in 27 January 2010.
25 April 2005
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3,436 |
| Start date | 19 May 2000 |
| Primary completion | 25 April 2005 |
| Estimated completion | 27 January 2010 |
| Sites | 157 locations across South Africa, Canada, United States, Peru |
Drugs / interventions tested
- Aromatase Inhibition Therapy
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Doxorubicin Hydrochloride — full drug profile →
- Laboratory Biomarker Analysis
- Paclitaxel — full drug profile →
- Tamoxifen Citrate
- Trastuzumab (trastuzumab) — full drug profile →
Conditions studied
- Breast Adenocarcinoma — all drugs for Breast Adenocarcinoma →
- HER2 Positive Breast Carcinoma — all drugs for HER2 Positive Breast Carcinoma →
- Stage IA Breast Cancer AJCC v7 — all drugs for Stage IA Breast Cancer AJCC v7 →
- Stage IB Breast Cancer AJCC v7 — all drugs for Stage IB Breast Cancer AJCC v7 →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, female only, with Breast Adenocarcinoma or HER2 Positive Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. 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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer.
Romond EH, Perez EA, Bryant J, Suman VJ, et al · · 2005 · cited 3676× · PMID 16236738 · DOI 10.1056/nejmoa052122 -
Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831.
Perez EA, Romond EH, Suman VJ, Jeong JH, et al · · 2014 · cited 687× · PMID 25332249 · DOI 10.1200/jco.2014.55.5730 -
Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31.
Perez EA, Romond EH, Suman VJ, Jeong JH, et al · · 2011 · cited 496× · PMID 21768458 · DOI 10.1200/jco.2011.35.0868 -
Trastuzumab containing regimens for early breast cancer.
Moja L, Tagliabue L, Balduzzi S, Parmelli E, et al · · 2012 · cited 309× · PMID 22513938 · DOI 10.1002/14651858.cd006243.pub2 -
The tale of TILs in breast cancer: A report from The International Immuno-Oncology Biomarker Working Group.
El Bairi K, Haynes HR, Blackley E, Fineberg S, et al · · 2021 · cited 204× · PMID 34853355 · DOI 10.1038/s41523-021-00346-1 -
HER2 and chromosome 17 effect on patient outcome in the N9831 adjuvant trastuzumab trial.
Perez EA, Reinholz MM, Hillman DW, Tenner KS, et al · · 2010 · cited 188× · PMID 20697084 · DOI 10.1200/jco.2009.26.2154 -
Association of Stromal Tumor-Infiltrating Lymphocytes With Recurrence-Free Survival in the N9831 Adjuvant Trial in Patients With Early-Stage HER2-Positive Breast Cancer.
Perez EA, Ballman KV, Tenner KS, Thompson EA, et al · · 2016 · cited 178× · PMID 26469139 · DOI 10.1001/jamaoncol.2015.3239 -
Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer.
Perez EA, Suman VJ, Davidson NE, Gralow JR, et al · · 2011 · cited 175× · PMID 22042958 · DOI 10.1200/jco.2011.36.7045
Verify or expand the search:
- PubMed search for NCT00005970
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00005970 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 14 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00005970.
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