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.
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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…
Contacts

lina zhang

15830981676

linazh_001@163.com

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