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NCT03949634
Cardiac Safety and Efficacy for Early-stage Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin(PLD)
Phase 3 trial testing PLD in Early Breast Cancer in 272 participants. Status unknown.
31 October 2019
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 272 |
| Start date | 1 September 2017 |
| Primary completion | 31 October 2019 |
| Estimated completion | 31 October 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- PLD — full drug profile →
- CTX
- Docetaxel (Docetaxel) — full drug profile →
- Paclitaxel — full drug profile →
- Doxorubicin (doxorubicin) — full drug profile →
Conditions studied
- Early Breast Cancer — all drugs for Early Breast Cancer →
Sponsor
Fudan University
Who can join
Adults 18 to 75, female only, with Early Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, multicenter, open, controlled Post-Marketing Study. 272 early stage female breast cancer patients who were histopathology confirmed with adjuvant chemotherapy indications were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and stratified by trastuzumab,age,baseline cardiac risk factors.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cardiac Cachexia: Unaddressed Aspect in Cancer Patients.
Saha S, Singh PK, Roy P, Kakar SS. · · 2022 · cited 20× · PMID 35326441 · DOI 10.3390/cells11060990 -
Pegylated liposomal doxorubicin + cyclophosphamide followed by taxane as adjuvant therapy for early-stage breast cancer: a randomized controlled trial.
Tang L, He M, Geng C, Fan Z, et al · · 2025 · PMID 40504550 · DOI 10.1093/oncolo/oyaf101
Verify or expand the search:
- PubMed search for NCT03949634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PLD
Trials testing the same drug.
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- NCT05536102 — The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) · Phase 2 · recruiting
- NCT03907969 — A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Ca · Phase 1, PHASE2 · completed
Other recruiting trials for Early Breast Cancer
Currently open trials in the same condition.
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- NCT06650423 — Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer · recruiting
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Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting
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 NCT03949634 (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 Fudan University
- Last refreshed: 14 May 2019
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/NCT03949634.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing