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NCT07019363
CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)
Phase 3 trial testing Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) in Breast Cancer in 1,903 participants. Currently enrolling.
15 May 2029
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,903 |
| Start date | 15 June 2025 |
| Primary completion | 15 May 2029 |
| Estimated completion | 15 April 2033 |
| Sites | 1 location across China |
Drugs / interventions tested
- Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) — full drug profile →
- Standard endocrine therapy combined with CDK4/6 Inhibitor — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Adjuvant Therapy — all drugs for Adjuvant Therapy →
Sponsor
Fudan University
Who can join
Adults 18 to 70, female only, with Breast Cancer or Adjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07019363
- 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 NCT07019363 (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 Fudan University
- Last refreshed: 21 January 2026
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/NCT07019363.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing