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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalpiciclib combined with Letrozole | Experimental | Dalpiciclib combined with Letrozole,28 days as one cycle.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalpiciclib combined with Letrozole | Drug | A multicenter, single arm, prospective Phase II clinical study |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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. | Estimated up to 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival 2(PFS2) | The time from the first chemotherapy for the metastatic stage by the subject to the first recording of tumor progression (evaluated according to RECIST 1.1 standards) or death from any cause. | Estimated up to 27-31 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | OS was defined as the time from the first study treatment to the date of death from any cause | Estimated up to 5 years |
| Objective Response Rate（ORR） | Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Luo, post-doctor | Contact | 18602866299 | tina621@163.com | |
| Xiaorong Zhong, post-doctor | Contact | 18980605984 | zhongxiaorong@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | China |
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| Estimated up to 23 months |
| Clinical Benefit Rate (CBR) | The percentage of participants who received study treatment and evaluated the best overall efficacy according to RECIST 1.1 criteria as complete remission (CR), partial remission (PR), and disease stability (SD) ≥ 24 weeks. | Estimated up to 23 months |
| Disease Control Rate (DCR) | Disease Control Rate (DCR) was defined as the percentage of patients with a complete response (CR), partial response (PR) and stable disease (SD). | Estimated up to 23 months |
| Patient Reported Outcome (PRO) | Using the European Five Dimensional Health Scale (EQ-5D) to allow patients to self-evaluate their quality of life | Estimated up to 5 years |
| Adverse events (AEs) | The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0. | Estimated up to 5 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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