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

Zhejiang University

Status and phase: Enrolling; Phase 2

Conditions: Luminal B/HER2-negative Breast Cancer

Treatments: Drug: Dalpiciclib combined with aromatase inhibitors

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05640778

2022-0500

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

neoadjuvant endocrine therapy

Experimental group

Description:

CDK4/6 inhibitor combined with aromatase inhibitor

Treatment:

Drug: Dalpiciclib combined with aromatase inhibitors