Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy

Shuangyue Liu

Status and phase: Not yet enrolling; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Dalpiciclib combined with Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT05979220

OBU-SC-BC-II-015

Details and patient eligibility

About

This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chemotherapy.

Enrollment: 178 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
2. Age: 18 - 75 years old
3. Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1
4. Functions of liver and kidney is normal
5. Agreed to take contraceptive measures during treatment

Exclusion criteria

1. Confirmed diagnosis of HER2 positive disease.
2. Central nervous system metastasis
3. Patients who received prior treatment with any CDK4/6 inhibitor.
4. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention；
5. Researchers believe that is not suitable for the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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178 participants in 1 patient group

Dalpiciclib combined with Letrozole

Experimental group

Description:

Dalpiciclib combined with Letrozole,28 days as one cycle. 1. Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle. 2. Letrozole: 2.5mg, p.o., once a day, continuous administration.

Treatment:

Drug: Dalpiciclib combined with Letrozole