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The purpose of this study is to evaluate the efficacy and safety of apatinib in patient with TNBC
NACT (Neoadjuvant chemotherapy) Increasingly widespread in clinical practice, there is still a substantial proportion of the patients NACT After failing to obtain ORR DCR , NACT Did not receive ORR DCR Patient access ORR DCR Patients have a higher risk of recurrence, and complete NACT The patient, the current standard therapy in the secondary stage of chemotherapy is no longer used, but non-ORR non-DCR After neo-adjuvant chemotherapy in patients with postoperative chemotherapy is worth exploring. Targeted drugs refer to interfere with tumor specific molecular processes and achieve inhibit or block the progression of drugs, its functioning is based on normal cells and tumor cells, differences, which makes the target specificity and side effects of the drug. Target drug is a pioneer in precision treatment of its interpretation of the individualized treatment based on the standard treatment. NCCN guidelines recommend paclitaxel in neoadjuvant chemotherapy is NACT first-line choice. At the Apatinib for dasatinib therapy in previous studies of breast cancer has a high level of performance, the Apatinib for dasatinib combined with paclitaxel in neoadjuvant therapy for breast cancer efficacy and safety is better than traditional treatments, is worthy of question.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | Apatinib Combined With Paclitaxel in Neoadjuvant Therapy of Locally Advanced Exploratory Research on Single-arm of TNBC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | 500 mg, po, qd. 12weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate | ten months |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | disease control rate | ten months |
| pCR | pathologic complete response | ten months |
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Inclusion Criteria:
patients between18 and 75 Years old;
patients with locally advanced breast cancer (TNM periodization:T is equal to or greater than 2,N is equal to 1,M is equal to 0)
clear for immunohistochemical is that: estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), the human epidermal growth factor receptor 2 is Negative ( IHC Her-2 0/+ , If ER- 、 PR- But Her-2 ++ , You need to do FISH/CISH Testing confirmed that Her-2 Amplification is negative);
The ECOG score is between 0 to 2 points;
The expected lifetime is ≥3 months;
Major organ function is normal, that meet the following criteria:
Blood test standards subject to:
HB≥90 g/L ;
ANC≥1.5×109 /L ;
PLT≥100×109 /L ;
Biochemical examination must meet the following criteria:
TBIL≤1.5xULN ( upper limit of normal value ) ;
ALT AST≤2.5×ULN ;
Serum Cr≤1.5×ULN And endogenous creatinine clearance rate ≥50 mL/min (Cockcroft-Gault formula ) ;
the women of childbearing age must do the pregnancy test ( serum or urine ) within 7 days when they are included in the trial, And the result was negative, and during the trial and at the time of giving experimental drugs after 8 weeks using the appropriate methods of contraception;
no difficulty in swallowing, swallowing oral medications;
the participants volunteered to join this study should sign the informed consent forms, have better compliance, work in with the follow-up
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong MD Liu, professor | Contact | 18622221169 | lh713@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong MD Liu | study principal investigator | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TianJin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | 300060 | China |
the plan to share IPD is under consideration
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | drug: Paclitaxel ,80mg/m2, d1, Once a week , A total of 12 weeks; 3 weeks as a cycle |
|
|
| DFS | disease free survival | ten months |
| Incidence of Treatment-Emergent Adverse Events [Safety] | incidence of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03 | ten months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |