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This study was a prospective, one-arm open phase II clinical trial. A systematic review of the pCR of apatinib in combination with the albumin paclitaxel and carboplatin regimens for the neoadjuvant therapy of triple-negative breast cancer, as well as the safety of treatment, at the same time, relevant exploratory biomarker research is conducted.
Neoadjuvant program: apatinib 250mg oral d1-21; albumin paclitaxel 260mg/m2 intravenous drip d1; carboplatin AUC=5-6 intravenous drip d1; 21 days for 1 cycle. The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated. If there is still no PD after 6 cycles, the surgical approach is based on the tumor condition and the patient's wishes. If the condition progresses to terminate the treatment regimen, the patient may receive subsequent local or systemic treatment. The follow-up period was followed up to assess safety and effectiveness.
MAIN OBJECTIVE: To systematically evaluate the pCR rate of apatinib combined with albumin paclitaxel and carboplatin regimen for neoadjuvant therapy of triple-negative breast cancer Secondary objective: To evaluate the safety of apatinib combined with albumin paclitaxel and carboplatin in neoadjuvant therapy for triple-negative breast cancer, an exploratory biomarker study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | apatinib 250mg oral d1-21; albumin paclitaxel 260mg/m2 intravenous drip d1; carboplatin AUC=5-6 intravenous drip d1; 21 days for 1 cycle. The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Neoadjuvant program: apatinib 250mg oral d1-21; albumin paclitaxel 260mg/m2 intravenous drip d1; carboplatin AUC=5-6 intravenous drip d1; 21 days for 1 cycle. The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated. |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Wei | Contact | 13851603656 | real.lw@163.com | |
| Yin Yongmei | Contact | 13951842727 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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|
| ID | Term |
|---|---|
| C553458 | apatinib |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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