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RECRUITING
NCT07900516
PHASE2

A Prospective, Phase II, Exploratory Study Protocol of a Chemotherapy Sensitivity-based Culmerciclib Combination Regimen in Neoadjuvant Therapy for HR+/HER2- Breast Cancer.

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

To explore the efficacy and safety of Culmerciclib combined with chemotherapy as neoadjuvant therapy for HR+/HER2- breast cancer patients who are insensitive to neoadjuvant TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy.

Official title: A Prospective, Phase II, Exploratory Study Evaluating Neoadjuvant Therapy With a Culmerciclib -Containing Combination Regimen in Patients With HR-Positive, HER2-Negative Breast Cancer Who Are Insensitive to Neoadjuvant TAC (Docetaxel, Doxorubicin, Cyclophosphamide) Chemotherapy.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-08-01

Completion Date

2028-08-01

Last Updated

2026-10-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

Kumoxili

Kumoxili 180mg po qd

DRUG

Docetaxel

Docetaxel 75mg/m2 iv q3w

DRUG

Epirubicin

Epirubicin 90-100mg/m2 iv q3w

DRUG

Cyclophosphamide

Cyclophosphamide 500mg/m2 iv q3w

DRUG

Letrozole

Letrozole 2.5mg po qd

DRUG

Everolimus (Afinitor®)

Everolimus 5mg po qd

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China