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RATIONALE:
The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer.
PURPOSE:
To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Apatinib+Paclitaxel+Cisplatin |
|
| Arm II | Active Comparator | Paclitaxel+Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Residual cancer burden (RCB 0-I rates） | RCB 0-I rates means RCB 0+I (good response) rates. | Time of surgery |
| Pathologic Complete Response (pCR) of the Primary Tumor in the Breast | Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen. | Time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| pCR in the Breast and Nodes | Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes. | Time of surgery |
| Near pCR in the Breast |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinsong Lu, MD | Renji Hospital, School of Medicine, Shanghai Jiao Tong University. | Principal Investigator |
| 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 |
|---|---|
| C553458 | apatinib |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel |
| Drug |
Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle |
|
| Cisplatin | Drug | Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle |
|
| Surgery | Procedure | Surgery |
|
Percentage of patients with the residual breast lump Less than 10%
| Time of surgery |
| Clinical and imaging response | To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment | Time of surgery |
| Number of Participants With Drug Related Treatment Adverse Events | Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. | an average of 16 weeks |
| Neo-bioscore | The Neo-Bioscore staging points were determined for each patient based on information from the medical records according to the previously published work（Mittendorf EA, et al. The Neo-Bioscore Update for Staging Breast Cancer Treated With Neoadjuvant Chemotherapy: Incorporation of Prognostic Biologic Factors Into Staging After Treatment. JAMA Oncol. United States; 2016;2:929-36.）. Neo-Bioscore = Clinical stages score + Pathological stages score + Tumor marker score Clinical stage I =0, Clinical stage IIA =0, Clinical stage IIB =1, Clinical stage IIIA =1, Clinical stage IIIB =2, Clinical stage IIIC =2, Pathological stage 0 =0, Pathological stage I =0, Pathological stage IIA =1, Pathological stage IIB =1, Pathological l stage IIIA =1, Pathological stage IIIB =1, Pathological stage IIIC =2, Tumor marker ER negative=1 Tumor marker Grade3=1 Tumor marker ERBB2 negative=1 | Time of surgery |
| Disease-free Survival (DFS) | DFS is defined as the time period between registration and first event | Measured through 5 years after study enrollment |
| Distant-disease- free survival (DDFS) | DDFS is defined as the time period between registration and first event | Measured through 5 years after study enrollment |
| Overall survival (OS) | OS is defined as the time period between registration and first event | Measured through 5 years after study enrollment |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |