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

NCT ID: NCT05512780

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-10
• Study Completion Date: 2024-08-10

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dalpiciclib+ letrozole

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.

Group Type: EXPERIMENTAL

Dalpiciclib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Letrozole

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Zhang L, Liu Y, Yang C, Ma J, Li Y, Luo R, Han J, Wang X, Zhang Z, Ma L, Cai H, Kong X, Wang Z, Zhou X, Shi J, Zhang Y, Wang M, Wang J, Geng C. Clinical efficacy and therapy response prediction of neoadjuvant dalpiciclib plus letrozole in postmenopausal patients with HR+/HER2- stage II-III breast cancer (DARLING 01): a single-arm, open-label, exploratory study. Breast Cancer Res. 2025 Feb 13;27(1):21. doi: 10.1186/s13058-025-01976-0.

Reference Type: DERIVED

PMID: 39948624 (View on PubMed)

Other Identifiers

2022037

Identifier Type: -

Identifier Source: org_study_id