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NCT01547741
A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Phase 3 trial testing Doxorubicin in Breast Cancer in 1,871 participants. Status unknown.
1 May 2022
Quick facts
| Lead sponsor | NSABP Foundation Inc |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,871 |
| Start date | 1 April 2012 |
| Primary completion | 1 May 2022 |
| Estimated completion | 1 November 2023 |
| Sites | 915 locations across United States, Puerto Rico |
Drugs / interventions tested
- Doxorubicin (doxorubicin) — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Docetaxel (Docetaxel) — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
NSABP Foundation Inc
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Invasive disease-free survival (IDFS)
Time frame: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
The time to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the
Sponsor's own description
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Anthracyclines in Early Breast Cancer: The ABC Trials-USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 (NRG Oncology).
Blum JL, Flynn PJ, Yothers G, Asmar L, et al · · 2017 · cited 201× · PMID 28398846 · DOI 10.1200/jco.2016.71.4147 -
Optimal systemic therapy for early breast cancer in women: a clinical practice guideline.
Eisen A, Fletcher GG, Gandhi S, Mates M, et al · · 2015 · cited 39× · PMID 25848340 · DOI 10.3747/co.22.2320 -
Triple-Negative Breast Cancer: A Review of Current Curative Intent Therapies.
MacDonald I, Nixon NA, Khan OF. · · 2022 · cited 29× · PMID 35877238 · DOI 10.3390/curroncol29070378 -
Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]).
Geyer CE, Blum JL, Yothers G, Asmar L, et al · · 2024 · cited 18× · PMID 38335467 · DOI 10.1200/jco.23.01428
Verify or expand the search:
- PubMed search for NCT01547741
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
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Other NSABP Foundation Inc trials
Trials by the same sponsor.
- NCT07058012 — A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel · Phase 2 · not yet recruiting
- NCT03628066 — Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Br · Phase 2 · completed
- NCT03457896 — Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Col · Phase 2 · unknown
- NCT03412643 — Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal · Phase 2 · unknown
- NCT03102047 — Study of Durvalumab (MEDI4736) After Chemo-Radiation for Microsatellite Stable Stage II-IV Rectal Cancer · Phase 2 · completed
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 NCT01547741 (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 NSABP Foundation Inc
- Last refreshed: 13 April 2022
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/NCT01547741.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing