Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
Recruiting
Phase 2
Interventional Study
Early Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,163 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Other
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About This Trial
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient is ≥ 18 years-old
* Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
* Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
* Histologically confirmed invasive breast ca…
Contacts