Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

Efficacy and Safety of Apatinib Added to Docetaxel and Cisplatin Neoadjuvant Therapy for Patients With Breast Cancer: a Randomized, Parallel Controlled Phase II Trial

To verify the role of apatinib in neoadjuvant therapy for breast cancer, the investigators designed a prospective, randomized, parallel-controlled phase II/III trial, to investigate the efficacy and safety of apatinib combined with TP (paclitaxel + cisplatin) or TP regimen alone as neoadjuvant therapy for stage II-III breast cancer treatment. 100 cases of eligible patients were diagnosed by core needle biopsy and immunohistochemistry, with the molecular subtypes of triple-negative, HER2+ or Luminal B, evaluated by pathological complete remission (pCR), objective response rate (ORR), adverse events, disease free survival (DFS) and OS, aiming at providing a new way for neoadjuvant therapy in breast cancer and anti-angiogenic treatment of malignant tumors.

Inclusion Criteria:

1. breast invasive carcinoma diagnosed by core needle biopsy, without previous treatments for breast cancer;
2. with the molecular subtypes of triple-negative, HER2+ or Luminal B, confirmed by immunohistochemistry;
3. breast cancer within stage IIb-IIIc, planned to receive neoadjuvant therapy;
4. women aged from 18 to 70 years old;
5. required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
6. left ventricular ejection fraction (LVEF) greater than 55% without clinical symptoms or signs of heart failure;
7. Adequate bone marrow, with white blood cell ≥4.0×109 /L，neutrophils ≥2.0×109 /L, platelet ≥100×109 /L, hemoglobin ≥ 90 g/L；
8. Serum creatinine ranges from 44 to 133 mol/L;
9. Glutamic pyruvic transaminase and Glutamic-oxalacetic Transaminase ≤2 times to superior limit of normal value;
10. bilirubin ≤ superior limit of normal value;
11. Expected survival ≥ 12 months;
12. pregnancy tests must be negative, and the couples of patients should agree to use effective contraception during treatment and the following one year;
13. approved by the institutional ethnics committee of the Fourth Hospital of Hebei Medical University, with signature to the Informed consent.

Exclusion Criteria:

1. severe systemic infection;
2. being allergic or intolerant to apatinib, paclitaxel, cisplatin;
3. having received any testing drugs, radiotherapy or other chemotherapy drugs within 30 days before being enrolled in this trial;
4. uncontrolled hypertension, severe heart function;
5. researchers believe that participating in the test does not meet the best interests of the patients (e.g. cause adverse health) or may interfere with the evaluation of response.