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NCT02214381
A Prospective, Multicenter, Open-label Comparison of Pre-surgical Myocet/ Cyclophosphamide (MC) q3w Followed by Either MC or Paclitaxel - Depending on Early Response Assessment by Ultrasound or by Toxicity for Elderly Non Frail Primary Breast Cancer Patients With Increased Risk of Relapse.
Phase 3 trial testing Myocet in Early Primary Breast Cancer in 80 participants. Completed in 15 January 2025.
1 October 2015
Quick facts
| Lead sponsor | West German Study Group |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 July 2014 |
| Primary completion | 1 October 2015 |
| Estimated completion | 15 January 2025 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- Myocet — full drug profile →
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Early Primary Breast Cancer — all drugs for Early Primary Breast Cancer →
Sponsor
West German Study Group — full company profile →
Who can join
70 and older, female only, with Early Primary 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 pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).
Time frame: After 5 years of follow-up.
Sponsor's own description
Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly non frail primary breast cancer patients with increased risk of relapse.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02214381
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Myocet
Trials testing the same drug.
- NCT03643276 — Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 · Phase 3 · recruiting
Other West German Study Group trials
Trials by the same sponsor.
- NCT07242352 — Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinica · Phase 3 · not yet recruiting
- NCT07178730 — NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple- · Phase 3 · not yet recruiting
- NCT03988036 — A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast C · Phase 2 · completed
- NCT04055493 — Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC · Phase 3 · active not recruiting
- NCT02269813 — PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative B · 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 NCT02214381 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by West German Study Group
- Last refreshed: 25 February 2025
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/NCT02214381.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing