Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

• Status: Enrolling by invitation
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hebei Medical University Fourth Hospital
• Treatments: Albumin-Bound Paclitaxel; Apatinib; Cisplatin; Paclitaxel

Criteria

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.