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

NCT05640778 | Unknown Phase 2

• 1 other identifier: 2022-0500
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment

  Assess ki67 level through biopsy samples of patients

  3 years

Secondary Outcomes (1)

• Objective response rate (ORR)

  3 years

Study Arms (1)

neoadjuvant endocrine therapy

EXPERIMENTAL

CDK4/6 inhibitor combined with aromatase inhibitor

Drug: Dalpiciclib combined with aromatase inhibitors

Interventions

Dalpiciclib combined with aromatase inhibitors DRUG

Dalpiciclib combined with letrozole or anastrozole

neoadjuvant endocrine therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• GeneCast Biotechnology Co., Ltd.: collaborator

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

RECRUITING

MeSH Terms

Interventions

Aromatase Inhibitors

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Central Study Contacts

Yunxiang Zhou

CONTACT

+8615868131018; yxzhou@zju.edu.cn

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: November 30, 2022
• First Posted: December 7, 2022
• Study Start: October 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: January 31, 2024

Record last verified: 2023-10

Locations

CN (1)