Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

Phase 2

• Conditions: Solid Tumor
• Interventions: Drug: Dalpiciclib

• Registration Number: NCT05512780
• Lead Sponsor: Hebei Medical University Fourth Hospital

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 Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Last Update Submitted: 2022-08-22
• Study First Posted: 2022-08-23
• Last Update Posted: 2022-08-23
• Study Start: 2022-09-10
• Primary Completion: 2023-08-10
• Study Completion: 2024-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• 1. Postmenopausal women aged ≥18 years, the definition of postmenopausal:

  2. the patients with the history of bilateral oophorectomy, or age ≥ 60 years; or

  3. 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 2. 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); 3. 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

• 1. Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) 2. Concurrently receiving any other anti-tumor therapy that those specified in the protocol; 3. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer; 4. Stage Ⅳ breast cancer;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dalpiciclib+ letrozole	Dalpiciclib	Dalpiciclib combined with Letrozole,28 days as one cycle. 1. Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle. 2. Letrozole: 2.5mg, p.o., once a day, continuous administration.

Primary Outcome Measures

Name	Time	Method
ORR	24 month	Objective response rate