Completed

A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment

What is being tested

Trastuzumab Emtansine

+ Trastuzumab Emtansine

Drug

Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

Over 18 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: November 2012

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: April 4, 2022

Sourced from a government-validated database.Claim as a partner

Study start date: November 27, 2012

Actual date on which the first participant was enrolled.

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

NCT01702571

Principal SponsorHoffmann-La Roche

Last updated: April 4, 2022

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

2185 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

9 inclusion criteria required to participate

Adequate organ function

Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy

Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2

HER2-positive disease determined locally

Show More Criteria

17 exclusion criteria prevent from participating

Brain metastases which are symptomatic

Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy

Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)

Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

This cohort will enroll all participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.

Group II

Experimental

This cohort will enroll Asian race participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 300 locations

CEMIC

Buenos Aires, ArgentinaOpen CEMIC in Google Maps

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Hospital Privado De Comunidad; General Practice

Mar del Plata, Argentina

Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research

North Sydney, Australia

Completed300 Study Centers