Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dalpiciclib combined with Letrozole.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Single Arm, Prospective Phase II Clinical Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
Overview
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.
Interventions
- Drug Dalpiciclib combined with Letrozole
A multicenter, single arm, prospective Phase II clinical study
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: Estimated up to 23 months]
Secondary outcome measures (1)
- Progression Free Survival 2(PFS2) [Time frame: Estimated up to 27-31 months]
Eligibility criteria
Inclusion criteria
- Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
- Age: 18 - 75 years old
- Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~1
- Functions of liver and kidney is normal
- Agreed to take contraceptive measures during treatment
Exclusion criteria
- Confirmed diagnosis of HER2 positive disease.
- Central nervous system metastasis
- Patients who received prior treatment with any CDK4/6 inhibitor.
- 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；
- Researchers believe that is not suitable for the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital, Sichuan University — Chengdu
Identifiers
NCT: NCT05979220 · OBU-SC-BC-II-015