Loading clinical trials...

COMPLETEDPHASE1

A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

NCT01513083•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Histologically or cytologically documented invasive metastatic breast cancer
•Human epidermal growth factor receptor 2 (HER2) -positive disease
•Adequate bone marrow and organ function (other than hepatic dysfunction allowed by protocol)
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
•Left ventricular ejection fraction \>/=50%
•Normal hepatic function, or mild to moderate hepatic impairment (Child-Pugh Class A or B)

Exclusion Criteria

•History of Grade \>/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab
•Investigational therapy or any other anticancer therapy \</=28 days before first study treatment
•Previous treatment with trastuzumab emtansine
•Brain metastases that are untreated or symptomatic or require therapy to control symptoms or any radiation, surgery or other therapy to control symptoms from brain metastases within 1 month of the first study treatment
•History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
•Current peripheral neuropathy of Grade \>/=2
•Child-Pugh Class C hepatic impairment
•Encephalopathy \>/= Grade 2
•For patients with normal hepatic function: history of drug or alcohol addiction or history of hepatitis B and/or hepatitis C
•Active hepatitis A, B and/or C
+6 more criteria

Locations (13)

Fort Myers, Florida, United States

Detroit, Michigan, United States

Portland, Oregon, United States

Nashville, Tennessee, United States

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Marseille, France

Paris, France

Toulouse, France

Catanzaro, Calabria, Italy

Key Dates

Start Date

February 1, 2012

Primary Completion Date

September 1, 2014

Completion Date

September 1, 2014

Last Updated

November 2, 2016

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

trastuzumab emtansine

DRUG

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

View study

RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer