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This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | 6 cycles of Paclitaxel,Carboplatin, Herceptin and Pertuzumab treatment with a good clinical benefit response depending on HR/HER-2 status. |
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| B | Experimental | 2 cycles of Paclitaxel,Carboplatin, Herceptin treatment with a good clinical benefit response depending on HR/HER-2 status following surgery |
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| CL4 | Experimental | HR+ and HER2-; No correlated pathway variation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A | Drug | Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle,6 cycles. Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle,6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic Complete Response (pCR) | pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy. | through study completion, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Shao, MD.PhD. | Contact | 18017312288 | zhimingshao@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shao Zhimin | Recruiting | Shanghai | Please Select | 200032 | China | |
| Fudan University Shanghai Cancer Center |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| B | Drug | Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. |
|
| CL4 | Drug | SHR6390(CDK4/6 inhibitor)125 mg qd(three week on one week off); oral letrozole 2.5 mg daily; Adebrelimab was given intravenously, 600mg each time, once every 2 weeks; Premenopause:Goserelin 3.6mg IM IM Q4W. |
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| Recruiting |
| Shanghai |
| 200032 |
| China |
|
| D017437 |
| Skin and Connective Tissue Diseases |