Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

NCT03580395 | Unknown Phase 2

• 1 other identifier: HebeiMUFH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

apatinib; neoadjuvant therapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is pathological complete remission (pCR)

  pCR was defined as no histological evidence of invasive tumor cells in the surgical breast specimen and draining nodes. The presence of residual ductal carcinoma-in situ was not included in the pCR category after neoadjuvant treatment.

  4 months

Secondary Outcomes (2)

• The second endpoint includes the objective response rate (ORR)

  4 months

• Adverse events (AE)

  4 months

Study Arms (2)

apatinib+TP

EXPERIMENTAL

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

Drug: Apatinib; Drug: paclitaxel; Drug: cisplatin

TP

SHAM COMPARATOR

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

Drug: paclitaxel; Drug: cisplatin

Interventions

Apatinib DRUG

500mg, day1-21,neoadjuvant therapy

apatinib+TP

paclitaxel DRUG

paclitaxel 165mg/m2 day 1

TP; apatinib+TP

cisplatin DRUG

cisplatin 40mg, day 1-3

TP; apatinib+TP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• severe systemic infection;
• being allergic or intolerant to apatinib, paclitaxel, cisplatin;
• having received any testing drugs, radiotherapy or other chemotherapy drugs within 30 days before being enrolled in this trial;
• uncontrolled hypertension, severe heart function;
• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

apatinib; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yunjiang Liu, MD.,PhD

  Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director and Vice-president

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: July 9, 2018
• Study Start: June 1, 2017
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

CN (1)