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NCT04215003
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC
Phase 1, PHASE2 trial testing A in Breast Cancer in 20 participants. Currently enrolling.
1 December 2024
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 20 January 2020 |
| Primary completion | 1 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 2 locations across China |
Drugs / interventions tested
- A
- B
- CL4 — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Fudan University
Who can join
Adults 18 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
The evolution of cyclin dependent kinase inhibitors in the treatment of cancer.
Jhaveri K, Burris Rd HA, Yap TA, Hamilton E, et al · · 2021 · cited 40× · PMID 34176404 · DOI 10.1080/14737140.2021.1944109 -
Comprehensive genomic profiling of breast cancers characterizes germline-somatic mutation interactions mediating therapeutic vulnerabilities.
Chen C, Lin CJ, Pei YC, Ma D, et al · · 2023 · cited 24× · PMID 38114467 · DOI 10.1038/s41421-023-00614-3 -
PIK3CAMutations in Breast Cancer Subtypes Other Than HR-Positive/HER2-Negative.
Ascione L, Zagami P, Nicolò E, Crimini E, et al · · 2022 · cited 9× · PMID 36579519 · DOI 10.3390/jpm12111793 -
A prospective, phase II, neoadjuvant study based on chemotherapy sensitivity in HR+/HER2- breast cancer-FINEST study.
Chen L, Wu WY, Liang F, Liu GY, et al · · 2025 · cited 6× · PMID 39754712 · DOI 10.1002/cac2.12649 -
Case Report: Extensive Tumor Profiling in Primary Neuroendocrine Breast Cancer Cases as a Role Model for Personalized Treatment in Rare and Aggressive Cancer Types.
Schaffrin-Nabe D, Schuster S, Tannapfel A, Voigtmann R. · · 2022 · PMID 35721079 · DOI 10.3389/fmed.2022.841441
Verify or expand the search:
- PubMed search for NCT04215003
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fudan University trials
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 NCT04215003 (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: 6 June 2024
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/NCT04215003.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing