MedTrace Logo

Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

NCT03580395 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-07-09

No results posted yet for this study

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

Interventions

DRUG

Apatinib

500mg, day1-21,neoadjuvant therapy

DRUG

paclitaxel

paclitaxel 165mg/m2 day 1

DRUG

cisplatin

cisplatin 40mg, day 1-3

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    lead OTHER

Principal Investigators

  • Yunjiang Liu, MD.,PhD · Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2022-07-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03580395 on ClinicalTrials.gov