MedTrace Logo

Carboplatin in EARLY Triple Negative Breast Cancer Trial (PEARLY Trial)

NCT02441933 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 878

Last updated 2024-06-04

No results posted yet for this study

Summary

This is a randomized, open-label, multicenter, phase III study comparing anthracyclines followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer.

Patients with stage II/III operable triple-negative breast cancer are eligible. Patients who need adjuvant chemotherapy after breast surgery as well as patients who need neoadjuvant chemotherapy for TNBC are eligible.

Conditions

Interventions

DRUG

taxane plus carboplatin

Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane plus carboplatin for 4 cycles The taxane plus carboplatin regimen can be selected based on the investigator's discretion from among the following two regimens. * Docetaxel (75 mg/m2) IV plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles * Paclitaxel (80 mg/m2) IV weekly for 12 doses plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles

DRUG

Taxane

Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane for 4 cycles The taxane regimen can be selected at the investigator's discretion from among the following two regimens. * Docetaxel (75 mg/m2) IV every 3 weeks for 4 cycles * Paclitaxel (80 mg/m2) IV weekly for 12 doses

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • South Korea

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 NCT02441933 on ClinicalTrials.gov