Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
Dalpiciclib combined with Letrozole: A multicenter, single arm, prospective Phase II clinical study
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Progression Free Survival (PFS) — Estimated up to 23 months The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.