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NCT00047099
A Randomized Phase III Trial Comparing FEC-Chemotherapy vs. EC-Doc-Chemotherapy in Patients With Primary Breast Cancer
Phase 3 trial testing cyclophosphamide in Breast Cancer in 446 participants. Completed in 1 March 2012.
1 February 2012
Quick facts
| Lead sponsor | Ludwig-Maximilians - University of Munich |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 446 |
| Start date | 1 August 2001 |
| Primary completion | 1 February 2012 |
| Estimated completion | 1 March 2012 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- cyclophosphamide (cyclophosphamide) — full drug profile →
- docetaxel (Docetaxel) — full drug profile →
- epirubicin hydrochloride
- fluorouracil — full drug profile →
- goserelin acetate (GOSERELIN ACETATE) — full drug profile →
- tamoxifen citrate
- adjuvant therapy
- radiation therapy
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Ludwig-Maximilians - University of Munich
Who can join
Adults 18 to 70, 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.
- Comparison of time to progression
Sponsor's own description
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells following surgery. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating women who have primary breast cancer.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Taxanes for adjuvant treatment of early breast cancer.
Willson ML, Burke L, Ferguson T, Ghersi D, et al · · 2019 · cited 45× · PMID 31476253 · DOI 10.1002/14651858.cd004421.pub3 -
Clinical feasibility of (neo)adjuvant taxane-based chemotherapy in older patients: analysis of >4,500 patients from four German randomized breast cancer trials.
Loibl S, von Minckwitz G, Harbeck N, Janni W, et al · · 2008 · cited 33× · PMID 18796139 · DOI 10.1186/bcr2144 -
Side effects of standard adjuvant and neoadjuvant chemotherapy regimens according to age groups in primary breast cancer.
Reinisch M, von Minckwitz G, Harbeck N, Janni W, et al · · 2013 · cited 25× · PMID 24715845 · DOI 10.1159/000346834
Verify or expand the search:
- PubMed search for NCT00047099
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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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 NCT00047099 (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 Ludwig-Maximilians - University of Munich
- Last refreshed: 29 May 2013
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/NCT00047099.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing