MedTrace Logo

Improved Breast Cancer Therapy (I-BCT-1) in the Neoadjuvant and Metastatic Setting

NCT02546232 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-06-04

No results posted yet for this study

Summary

The purpose of the study is to investigate the molecular biology of the tumor in relation to treatment response to chemotherapy, in particular paclitaxel compared to the combination paclitaxel and carboplatin. The study is carried out in two different, separate cohorts:

Cohort I: Patients with large primary breast cancer (\> 2.0 cm) including locally advanced disease, are treated with weekly paclitaxel for 12 weeks, before continuing on anthracycline containing regimen for another 12 weeks before surgery. Patient are randomized 1:1 to receive carboplatin in addition to paclitaxel for the first 12 weeks of the treatment.

Cohort II: Patients with metastatic disease, available for biopsies before and during therapy are included to receive paclitaxel for 24 weeks. Patients are randomized 1:1 to receive paclitaxel alone or paclitaxel in combination with carboplatin.

Conditions

Interventions

DRUG

Carboplatin

Chemotherapy

DRUG

Paclitaxel

Chemotherapy

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Olav Engebraaten, MD, PhD · Department of Oncology, Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2021-12-31
Completion
2028-12-31

Countries

  • Norway

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 NCT02546232 on ClinicalTrials.gov