Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer (EBC)
Recruiting
Phase 2
Interventional Study
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
- 144 (estimated)
- Sponsor
- Hebei Medical University Fourth Hospital · Other
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About This Trial
This study is a multi-center, randomized, prospective phase II clinical trial aimed at exploring and evaluating the efficacy of dalpiciclib combined with AI in neoadjuvant treatment for ER strong positive(ER≥50%),HER2-negative, Ki-67≤20%,T1-3N1M0 postmenopausal breast cancer. The primary objectives are to demonstrate non-inferiority in efficacy compared to chemotherapy and to assess its superior s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Sign the informed consent form to participate in the clinical research.
2. Confirmed postmenopausal females diagnosed with invasive breast cancer.
3. Clinical stage T1-3N1M0.
4. Pathological examination confirmed: Strong positive for ER, negative for HER2. HER2 negative: Immu…
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