Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

Hebei Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Apatinib; Drug: cisplatin; Drug: paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03580395

HebeiMUFH

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

apatinib+TP

Experimental group

Description:

TP neoadjuvant chemotherapy (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3) combined with apatinib (received TP concurrently with apatinib 500mg, day1-21).

Treatment:

Drug: cisplatin

Drug: Apatinib

Drug: paclitaxel

TP

Sham Comparator group

Description:

TP neoadjuvant chemotherapy alone (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3).

Treatment:

Drug: cisplatin

Drug: paclitaxel