MedTrace Logo

Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer

NCT05227131 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-07-11

No results posted yet for this study

Summary

This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate the efficacy and safety of margetuximab in combination with tucatinib and capecitabine in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.

Conditions

Interventions

DRUG

Margetuximab

Margetuximab (15 mg/kg) will be administrated by intravenous infusion on Day 1 of each cycle.

DRUG

Tucatinib

Tucatinib (300 mg) will be administrated orally twice daily (every 12 hours) continuously in 21-day cycles.

DRUG

Capecitabine

Capecitabine (1000 mg per square meter of body-surface area) will be administrated orally twice daily on days 1 to 14 of each 21-day cycle

Sponsors & Collaborators

  • MacroGenics

    collaborator INDUSTRY

  • Seagen Inc.

    collaborator INDUSTRY

  • MedSIR

    lead OTHER

Principal Investigators

  • Javier Cortés, MD, PhD · MedSIR

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2024-10-31
Completion
2024-10-31

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT05227131 on ClinicalTrials.gov