Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT04437160

Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

Led by Chinese Academy of Medical Sciences · Updated on 2020-06-18

286

Participants Needed

1

Research Sites

408 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.

CONDITIONS

Official Title

Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with confirmed invasive breast adenocarcinoma
  • Triple negative breast cancer (ER < 10%, PgR < 10%, HER2 negative)
  • Clinical stage T1-4, N0-3, M0, eligible for neoadjuvant chemotherapy
  • Completed at least 4 cycles of platinum and taxane neoadjuvant chemotherapy without tumor progression
  • Underwent surgery to remove tumor and lymph nodes after neoadjuvant chemotherapy
  • Residual invasive disease ≥1 cm in breast and/or positive axillary lymph nodes after chemotherapy
  • ECOG performance status 0-1
  • No severe heart, lung, liver, or kidney disease
  • Adequate blood counts and organ function
  • Randomization within 6 weeks after definitive breast surgery
Not Eligible

You will not qualify if you...

  • Previous neoadjuvant chemotherapy with anthracycline or drugs other than platinum and taxanes
  • Neoadjuvant chemotherapy using platinum or taxanes alone
  • Received other adjuvant therapy
  • Evidence of distant metastases before randomization
  • Unsuitable for anthracycline treatment as judged by investigators
  • History of other cancers except carcinoma in situ

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

P

Pin ZHANG, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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