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

NCT05512780 | Unknown Phase 2

• 1 other identifier: 2022037
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate

  24 month

Study Arms (1)

Dalpiciclib+ letrozole

EXPERIMENTAL

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.

Drug: Dalpiciclib

Interventions

Dalpiciclib 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.

Also known as: Letrozole

Dalpiciclib+ letrozole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 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;

You may not qualify if:

• \. 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;

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Related Publications (1)

• 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.

  PMID: 39948624 DERIVED

MeSH Terms

Interventions

dalpiciclib; Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: September 10, 2022
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2024
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share