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CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer BREAST CANCER

NCT03712956 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-09-21

No results posted yet for this study

Summary

A single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer.

The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment.

Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.

Conditions

Interventions

DRUG

Caelyx®

Caelyx® every two weeks for 8 courses

Sponsors & Collaborators

  • Janssen-Cilag International NV

    collaborator INDUSTRY

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Elisabetta Munzone, MD · European Institute of Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-25
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

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 NCT03712956 on ClinicalTrials.gov