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This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients.
Explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in high risk early, locally advanced and Inflammatory breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2 negative breast cancer cohort | Experimental | Human Epidermal Growth Factor Receptor 2 (HER2 ) negative breast cancer utidelone and cisplatin |
|
| HER2 positive breast cancer cohort | Experimental | Human Epidermal Growth Factor Receptor 2 (HER2 ) positive breast cancer utidelone,cisplatin,tratuzumab and pertuzumab (both Intravenous preparations or subcutaneous preparations can be used) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| utidelone | Drug | utidelone 50mg/m2,ivgtt,d1,8,15,22, q28d, up to 4 cycle; |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCR | ypT0/is ypN0 | through surgery completion, an average of 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| breast pCR | ypT0/is | through surgery completion, an average of 16 weeks |
| RCB 0/I rate | ratio of patients who achieved RCB 0 or RCB I |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200127 | China | ||
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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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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | cisplatin25mg/m2,ivgtt,d1,8,15;q28d, up to 4 cycle. |
|
|
| Trastuzumab | Drug | Trastuzumab 8mg/kg, ivgtt, d1, then 6mg/kg, q21d or Trastuzumab 4mg/kg, ivgtt, d1, then 2mg/kg, q7d or Trastuzumab Injection(Subcutaneous Injection)600mg,subcutaneous Injection,d1,q21d |
|
| Pertuzumab | Drug | Pertuzumab 840mg, ivgtt, d1, then 420mg, q21d or Pertuzumab/trastuzumab/hyaluronidase |
|
| through surgery completion, an average of 16 weeks |
| RCB class | RCB 0, RCB I, RCB II, RCB III | through surgery completion, an average of 16 weeks |
| Rate of lymph node negative | ratio of patients who achieved lymph node negative | through surgery completion, an average of 16 weeks |
| ORR by physical examination | ratio of patients who achieved complete response or partial response by physical examination | After completing neoadjuvant therapy before surgery, an average of 16 weeks |
| ORR by MRI | ratio of patients who achieved complete response or partial response by MRI | After completing neoadjuvant therapy before surgery, an average of 16 weeks |
| CBR by physical examination | ratio of patients who achieved complete response or partial response or stable disease by physical examination | After completing neoadjuvant therapy before surgery, an average of 16 weeks |
| CBR by MRI | ratio of patients who achieved complete response or partial response or stable disease by MRI | After completing neoadjuvant therapy before surgery, an average of 16 weeks |
| iDFS | It is defined as the time from first dose of study intervention administration to the first occurrence of ipsilateral invasive cancer recurrence, contralateral invasive breast cancer, local and/or regional invasive cancer recurrence, distant metastasis or death from any cause. | 2year,3year,5year,8year,10year |
| EFS | It is defined as the time from first dose of study intervention administration to the first occurrence of local and/or regional recurrence, contralateral breast cancer, distant metastasis or death from any cause. | 2year,3year,5year,8year,10year |
| DDFS | It is defined as the time from first dose of study intervention administration to the first distant metastasis or death from any cause. | 2year,3year,5year,8year,10year |
| OS | It is defined as the time from first dose of study intervention administration to death from any cause. | 2year,3year,5year,8year,10year |
| Quality of Life | EORTC-QLQ-C30 | Through study completion,an average of 1 year |
| Quality of Life | EORTC-QLQ-BR23 | Through study completion,an average of 1 year |
| Safety | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Through study completion,an average of 1 year |
| Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients | Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients | After completing neoadjuvant therapy before surgery, an average of 16 weeks |
| Renji Hospital |
| Shanghai |
| China |
| D017437 |
| Skin and Connective Tissue Diseases |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |