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Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer

NCT03982485 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-04-30

No results posted yet for this study

Summary

RATIONALE:

The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer.

PURPOSE:

To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients

Conditions

Interventions

DRUG

Apatinib

Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week

DRUG

Paclitaxel

Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle

DRUG

Cisplatin

Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle

PROCEDURE

Surgery

Surgery

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jinsong Lu, MD · Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2023-03-29
Completion
2031-03-29

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 NCT03982485 on ClinicalTrials.gov