NCT03201861

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

Phase 3 Study of Weekly Paclitaxel in Combination With Cisplatin as Adjuvant Chemotherapy for Early Stage Human Epidermal Growth Factor Receptor-2 (HER2) Negative Breast Cancer in High-risk Women

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 762 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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 .

Detailed description

In this trial, patients will be randomly assigned in a 2:1 ratio to receive cisplatin-based adjuvant chemotherapy and to standard adjuvant chemotherapy.

Conditions

• Tubular Breast Cancer
• Mucinous Breast Cancer
• Invasive Duct Carcinoma of Breast

Interventions

Type	Name	Description
DRUG	Paclitaxel, Cisplatin	weekly paclitaxel and cisplatin
DRUG	EC to docetaxel or paclitaxel	Standard adjuvant chemotherapy recommended by guideline

Timeline

• Start date: 2017-07-27
• Primary completion: 2027-08-31
• Completion: 2027-12-31
• First posted: 2017-06-28
• Last updated: 2025-05-16

Locations

1 site across 1 country: China