MedTrace Logo

High Dose Chemotherapy in Oligo-metastatic Homologous Recombination Deficient Breast Cancer

NCT01646034 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-10-12

No results posted yet for this study

Summary

This study investigates the effect of high-dose alkylating chemotherapy compared with standard chemotherapy as part of a multimodality treatment approach in patients with oligo-metastatic breast cancer harboring homologous recombination deficiency.

Conditions

Interventions

DRUG

carboplatin, thiotepa, and cyclophosphamide

tandem intermediate-dose alkylating therapy: carboplatin 800 mg/m2, thiotepa 240 mg/m2, and cyclophosphamide 3000 mg/m2) with PBPC-reinfusion.

DRUG

chemotherapy (docetaxel, doxorubicin, cyclofosfamide, carboplatin, paclitaxel, gemcitabine)

* chemotherapy naïve;three cycles of docetaxel, doxorubicin, and cyclofosfamide * chemotherapy naïve;1 cycle of dose-dense Adriamycin and cyclophosphamide followed by 4 cycles of carboplatin and paclitaxel * previously received anthracyclines without taxanes;three cycles of carboplatin and paclitaxel * previously received anthracyclines and taxanes;three cycles of carboplatin and gemcitabine

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Gabe S Sonke, MD · NKI-AVL, Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2023-01-31
Completion
2026-10-31

Countries

  • Netherlands

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 NCT01646034 on ClinicalTrials.gov