NCT05512780UnknownPhase 2
An Exploratory Clinical Study of CDK4/6 Inhibitor Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer
Hebei Medical University Fourth Hospital0 sites30 target enrollmentStarted: September 10, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- ORR
Study Overview
Brief Summary
This is a single-arm, open-label, exploratory clinical study
Detailed Description
This is a single-arm, open-label, exploratory clinical study initiated by the investigator to evaluate the objective response rate (ORR), efficacy, and safety of Dalpiciclib combined with letrozole in the neoadjuvant treatment of stage Ⅱ-Ⅲ HR+/HER2- breast cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Postmenopausal women aged ≥18 years, the definition of postmenopausal:
- •the patients with the history of bilateral oophorectomy, or age ≥ 60 years; or
- •Age <60, natural postmenopausal state (defined as the spontaneous cessation of regular menstruation for at least 12 consecutive months, without other pathological or physiological causes), E2 and FSH at the postmenopausal levels
- •All patients were estrogen receptor (ER) positive (>10%), HER2 -negative invasive breast cancer regardless of PR expression level. Immunohistochemistry (IHC) score of 0+, or 2+ confirmed by pathology laboratory and negative in situ hybridization (ISH) test (HER-2/CEP17 ratio <2.0);
- •Treatment-naive patients with stage Ⅱ-Ⅲ tumors whose tumor staging meets the criteria of the 8th edition of the American Joint Committee on Cancer (AJCC) Staging;
Exclusion Criteria
- •Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
- •Concurrently receiving any other anti-tumor therapy that those specified in the protocol;
- •Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer;
- •Stage Ⅳ breast cancer;
Arms & Interventions
Dalpiciclib+ letrozole
Experimental
Dalpiciclib combined with Letrozole,28 days as one cycle.
- Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.
- Letrozole: 2.5mg, p.o., once a day, continuous administration.
Intervention: Dalpiciclib (Drug)
Outcomes
Primary Outcomes
ORR
Time Frame: 24 month
Objective response rate
Secondary Outcomes
No secondary outcomes reported
Investigators
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