Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER)

Phase 2

Recruiting

• Conditions: Luminal B/HER2-negative Breast Cancer
• Interventions: Drug: Dalpiciclib combined with aromatase inhibitors

• Registration Number: NCT05640778
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-07
• Status Verified: 2023-10
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Primary Completion: 2024-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

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

Inclusion Criteria

• Patient is ≥ 18 years-old at the time of consent to participate this trial
• Famale stage I-III breast cancer patients
• HR-positive（ER≥10%）, HER2-negtive invasive breast cancer, either Ki67≥20% and/or PgR<20%
• No prior anti-cancer treatment
• ECOG 0-1

Exclusion Criteria

• Known to have other aggressive malignant tumor in the past 5 years.
• Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant metastasis confirmed by pathology.
• There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
• Female patients during pregnancy or lactation.
• The investigator determines that subjects are not appropriate to participate in the study due to other factors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neoadjuvant endocrine therapy	Dalpiciclib combined with aromatase inhibitors	CDK4/6 inhibitor combined with aromatase inhibitor

Primary Outcome Measures

Name	Time	Method
Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment	3 years	Assess ki67 level through biopsy samples of patients

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	3 years	the proportion of people with clinical complete response(CR) or partial response(PR), per RECIST v1.1

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China