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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| First Hospital of China Medical University | OTHER |
| Sun Yat-sen University | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University |
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This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Patients with SNF3 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate efficacy of PARP inhibitor in SNF3 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Fluzoparib(Parp inhibitor) and endocrine therapy. |
|
| Cohort 2 | Active Comparator | In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Parp inhibitor |
| |
| Dalpiciclib |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | time to progressive disease (according to RECIST1.1) | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1) | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) |
| CBR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Shao | Contact | 86-021-64175590 | 8888 | zhimingshao@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast cancer institute of Fudan University Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
| C000720752 | dalpiciclib |
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| OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| Chongqing University Cancer Hospital | OTHER |
| Northern Jiangsu People's Hospital | OTHER |
| Fujian Medical University Union Hospital | OTHER |
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| Shanghai First Maternity and Infant Hospital | OTHER |
| Shanghai 6th People's Hospital | OTHER |
| Affiliated Hospital of Nantong University | OTHER |
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| Drug |
CDK4/6 inhibitor |
|
| Fulvestrant/AI | Drug | Endocrine therapy |
|
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants. |
| : Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) |
| OS | time to death due to any cause | Randomization to death from any cause, through the end of study (approximately 5 years) |