Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
NCT03201861

Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

Led by RenJi Hospital · Updated on 2025-05-16

762

Participants Needed

1

Research Sites

544 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .

CONDITIONS

Official Title

Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 70 years
  • Histologically confirmed early invasive breast cancer
  • Accepted surgical treatment for breast cancer
  • No prior breast cancer treatment before surgery
  • Triple-negative breast cancer or HR positive breast cancer with at least one of: axillary lymph node positive, tumor size 2 cm and Ki-67 > 20%, tumor size 2 cm and grade III, or tumor size 2 cm and age < 35 years
  • HER2 negative by immunohistochemistry or FISH
  • Performance status 0-1
  • Adequate bone marrow function: WBC 64.0x10^9/L, ANC 61.5x10^9/L, platelets 61100x10^9/L, hemoglobin 6590 g/L
  • Liver and kidney function within 1.5 times normal limits
  • No major organ dysfunction
Not Eligible

You will not qualify if you...

  • Metastatic breast cancer
  • Pregnant or breastfeeding
  • Any sensory or motor nerve disorders
  • Bilateral primary breast cancer (excluding DCIS on one side)
  • Medical conditions intolerant to chemotherapy including uncontrolled cardiovascular disease or severe infection
  • Prior chemotherapy for any malignancy other than breast cancer
  • Known severe allergy to any study drugs

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

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

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Research Team

Y

Yueyao Du, M.D.

CONTACT

J

Jie Zhang, M.D.

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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