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Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer

NCT05041842 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-11-17

No results posted yet for this study

Summary

The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group.

These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease.

The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.

Conditions

  • Metastatic Breast Cancer With a Isolated Brain Progression

Interventions

DRUG

Tucatinib

300 mg orally twice daily

DRUG

Pertuzumab

Initial loading: 840 mg Maintenance: 420 mg, 3-weekly

DRUG

Trastuzumab

Intravenous formulation : Initial loading: 8 mg/kg Maintenance: 6 mg/kg, 3-weekly Subcutaneous formulation: 600 mg (fixed dose regardless of patient's body weight), 3-weekly

DRUG

Hormone therapy

Anastrozole (1 mg/day) or letrozole (2.5 mg/day) or fulvestrant (2x250 mg at day 1 and day 15 then every 4 weeks after the first injection)

DRUG

Pertuzumab/ Trastuzumab

Initial loading: 1200 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight) Maintenance: 600 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight), 3-weekly

Sponsors & Collaborators

  • Seagen Inc.

    collaborator INDUSTRY

  • ARCAGY/ GINECO GROUP

    collaborator OTHER

  • UNICANCER

    lead OTHER

Principal Investigators

  • Thomas Bachelot, MD · Centre Leon Berard

  • Anne-Claire Hardy-Bessard, MD · Centre Armoricain d'Oncologie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2025-04-30
Completion
2026-04-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT05041842 on ClinicalTrials.gov