NCT05979220Not yet recruitingPhase 2
Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 178 (estimated)
- First submitted
- 19 May 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Shuangyue Liu
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05979220
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 178
- From 1 Dec 2023 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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；
Other illness
- Confirmed diagnosis of HER2 positive disease.
Other
- Central nervous system metastasis
- Researchers believe that is not suitable for the study
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.