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

NCT ID: NCT05640778

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-10-31

Brief Summary

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

Conditions

Luminal B/HER2-negative Breast Cancer

Study Design

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

Study Groups

neoadjuvant endocrine therapy

CDK4/6 inhibitor combined with aromatase inhibitor

Group Type: EXPERIMENTAL

Dalpiciclib combined with aromatase inhibitors

Intervention Type: DRUG

Dalpiciclib combined with letrozole or anastrozole

Interventions

Dalpiciclib combined with aromatase inhibitors

Dalpiciclib combined with letrozole or anastrozole

Intervention Type: DRUG

Eligibility Criteria

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.

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

Sponsors

GeneCast Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunxiang Zhou

Role: CONTACT

yxzhou@zju.edu.cn

+8615868131018

Facility Contacts

Yiding Chen

Role: primary

Other Identifiers

2022-0500

Identifier Type: -

Identifier Source: org_study_id