Clinical Trial: NCT05431504
The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis
Status:
NOT YET RECRUITINGPhase:
Phase 2| Lead Sponsor: | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Information Provided By: | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Last Update Posted: | 2022-06-24 |
Study Overview
Brief Summary
This is a multicenter, single-arm, open-label, Simon's two-stage exploratory clinical trial. 18 eligible patients with advanced breast cancer with visceral crisis will enroll in stage I. If the study enter stage 2 and continue to include 53 assessable subjects (35 in stage 2). All eligible patients will receive Dalpiciclib plus endocrine therapy chosen by the Physicians until disease progression, death or intolerable toxicity. Tumor assessment was conducted according to RECIST 1.1 criteria.
Official Title
Conditions
Intervention / Treatment
- Drug: Dalpiciclib in combination with endocrine therapy by Physicians choice
Other Study ID Numbers
- MA-BC-II-033
Start Date (Estimated)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Information Provided By: | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Last Update Posted: | 2022-06-24 |
Study Overview
Brief Summary
This is a multicenter, single-arm, open-label, Simon's two-stage exploratory clinical trial. 18 eligible patients with advanced breast cancer with visceral crisis will enroll in stage I. If the study enter stage 2 and continue to include 53 assessable subjects (35 in stage 2). All eligible patients will receive Dalpiciclib plus endocrine therapy chosen by the Physicians until disease progression, death or intolerable toxicity. Tumor assessment was conducted according to RECIST 1.1 criteria.
Official Title
Conditions
Intervention / Treatment
- Drug: Dalpiciclib in combination with endocrine therapy by Physicians choice
Other Study ID Numbers
- MA-BC-II-033