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

Sponsor
Hebei Medical University Fourth Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05512780
Collaborator
(none)
30
Enrollment
1
Arm
23
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a single-arm, open-label, exploratory clinical study

Condition or Disease Intervention/Treatment Phase
Phase 2

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
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Sep 10, 2022
Anticipated Primary Completion Date :
Aug 10, 2023
Anticipated Study Completion Date :
Aug 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dalpiciclib+ letrozole

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.

Drug: Dalpiciclib
An exploratory study of a single-arm, open design All subjects enrolled will receive the following treatment: Dalpiciclib combined with Letrozole, 28 days as one cycle.
Other Names:
  • Letrozole

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ORR [24 month]

      Objective response rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Postmenopausal women aged ≥18 years, the definition of postmenopausal:

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

    2. 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;

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hebei Medical University Fourth Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hebei Medical University Fourth Hospital
    ClinicalTrials.gov Identifier:
    NCT05512780
    Other Study ID Numbers:
    • 2022037
    First Posted:
    Aug 23, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Letrozole

    Study Results

    No Results Posted as of Aug 23, 2022