Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer (APP)

  • STATUS
    Recruiting
  • End date
    Apr 16, 2023
  • participants needed
    196
  • sponsor
    RenJi Hospital
Updated on 26 March 2022
paclitaxel
growth factor
VEGFR2
HER2
adjuvant therapy
erbb2
breast adenocarcinoma
her2/neu-negative breast cancer

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

Details
Condition Breast Cancer
Treatment cisplatin, Paclitaxel, Surgery, apatinib
Clinical Study IdentifierNCT03982485
SponsorRenJi Hospital
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

18~70 year-old,Female
Patients with histologically confirmed primary invasive breast adenocarcinoma,cT2-4N0-3M0
ECOG 0-1
HER2-negative tumor in biopsy, defined as: Immunohistochemical (IHC) 0-1+ or IHC 2+ confirmed as FISH negative
Adequate organ function

Exclusion Criteria

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
Pregnant or breastfeeding patients
Metastatic or recurrent patients
Any evidence of sense or motor nerve disorders
Any concurrent malignancy other than breast cancer
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
Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
Coagulation disorders
Artery or venous thrombosis occurred within 6 months before the study begins
Have received prior treatment with a VEGFR TKI
Clear my responses

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