Apatinib: Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week
Paclitaxel: Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
Cisplatin: Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
Surgery: Surgery
Study summary
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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. 18\~70 year-old，Female
2. Patients with histologically confirmed primary invasive breast adenocarcinoma,cT2-4N0-3M0
3. ECOG 0-1
4. HER2-negative tumor in biopsy, defined as: Immunohistochemical (IHC) 0-1+ or IHC 2+ confirmed as FISH negative.
5. Adequate organ function
Exclusion Criteria:
1. Unwilling to use adequate contraceptive protection during the process of the study and for at least 8 weeks after the last dose of study drug.
2. Pregnant or breastfeeding patients
3. Metastatic or recurrent patients
4. Any evidence of sense or motor nerve disorders
5. Any concurrent malignancy other than breast cancer
6. Uncontrolled hypertension with hypotensive drugs therapy (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg). Patients with grade I or above myocardial ischemia or myocardial infarction or arrhythmia (including QT interval ≥ 440 ms) or cardiac insufficiency
7. Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
8. Coagulation disorders
9. Artery or venous thrombosis occurred within 6 months before the study begins
10. Have received prior treatment with a VEGFR TKI
Primary outcome measure(s)
Residual cancer burden (RCB 0-I rates） — Time of surgery RCB 0-I rates means RCB 0+I (good response) rates.
Pathologic Complete Response (pCR) of the Primary Tumor in the Breast — Time of surgery Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.
Trial sites (1)
Facility
City
Region
Status
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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