NCT02879513

Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

A Randomized Phase III Trial of Comparing Combination Administration of Paclitaxel and Cisplatin Versus CEF as Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial will compare the administration of 2 cycles of paclitaxel and cisplatin (DP) versus 4 cycles of CEF as adjuvant chemotherapy for the patients with locally advanced breast cancer and who were pathological partial response to DP as neoadjuvant chemotherapy. Those who had pathological complete response to DP will be randomized to have 2 cycles of DP or have no further chemotherapy.

Detailed description

All the patients who had neoadjuvant chemotherapy and had pathological complete response (pCR) or partial response to DP will enrolled in this trial. Those who had pCR will randmized to have two cycles of DP as adjuvant chemotherapy or have no further chemotherapy. Those patients who had PR will be randomized to have two cycles of DP or four cycles of CEF. All the patients with hormonal receptor positive or Her2 overexpress tumors are allowed to accept endocrine therapy or anti-Her2 target therapy.

Conditions

• Invasive Ductal Breast Cancer
• Tubular Breast Cancer
• Mucinous Breast Cancer
• Inflammatory Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel
DRUG	Cisplatin
DRUG	Epirubicin
DRUG	Cyclophosphamide
DRUG	5-fluoruracil

Timeline

• Start date: 2014-01-01
• Primary completion: 2020-06-01
• Completion: 2022-12-01
• First posted: 2016-08-25
• Last updated: 2020-03-23

Locations

1 site across 1 country: China