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Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer

NCT04193059 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1560

Last updated 2025-11-26

No results posted yet for this study

Summary

This study is a randomized, single center, phase III clinical trial comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC\*4-T\*4) verses 6 cycles of weekly paclitaxel combined with carboplatin (PCb\*6) in the adjuvant chemotherapy of non-triple negative breast cancer patients. The study is divided in to 2 branches: PANSY-1 and PANSY-2. PANSY-1 is a study of hormone receptor (HR)-positive/human epidermal growth factor receptor-2 (HER2)-negative patients with ≥4 positive lymph node, while PANSY-2 is a study of HER2-positive patients with ≥1 positive lymph node.

Conditions

Interventions

DRUG

Paclitaxel

paclitaxel 80 mg/m\^2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.

DRUG

Carboplatin

carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.

DRUG

Epirubicin

epirubicin 90 mg/m\^2 ivgtt d1, 21 days per cycle, 4 cycles.

DRUG

Cyclophosphamide

cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle, 4 cycles.

DRUG

Trastuzumab

trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy; or trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).

DRUG

Pertuzumab

pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant pertuzumab (420mg ivgtt every 3 weeks).

DRUG

Docetaxel

docetaxel 100 mg/m\^2 ivgtt d1, 21 days per cycle, 4 cycles.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • ZhiMin Shao, MD, PhD · Fudan 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
2019-12-20
Primary Completion
2026-07-31
Completion
2027-07-31

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 NCT04193059 on ClinicalTrials.gov