A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen - Full Text View

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00932373

Purpose

This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive DMARD-IR PJD metastatic breast cancer (MBC) who have previously received trastuzumab. The study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine the dose and schedule to be used in Phase II.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: trastuzumab-MCC-DM1	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Trastuzumab-MCC-DM1 (PRO132365) Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer myotonic dystrophy

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Frequency and nature of Dose-limiting toxicities (DLTs) [ Time Frame: Through study completion or early study discontinuation ]
Frequency and nature of serious adverse events [ Time Frame: Through study completion or early study discontinuation ]
Nature, severity, and relatedness of adverse events [ Time Frame: Through study completion or early study discontinuation ]
Pharmacokinetic (PK) parameters, including total exposure, maximum concentration (Cmax) clearance, volume of distribution, and half-life for trastuzumab-MCC-DM1 and trastuzumab, and AUC, Cmax, and half-life for DM1 [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures:

Objective response [ Time Frame: Complete response or partial response as determined on two consecutive occasions ≥ 4 weeks apart ]
Duration of response [ Time Frame: Time from the initial response to disease progression or death from any cause ]
Progression-free survival [ Time Frame: Time from first dose to documented disease progression or death ]

Enrollment:	55
Study Start Date:	April 2006

Arms	Assigned Interventions
1: Experimental	Drug: trastuzumab-MCC-DM1 Intravenous escalating dose

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically documented, incurable, locally advanced or metastatic breast cancer
Evaluable or measurable HER2-positive disease
History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer
Previous treatment with chemotherapy for MBC

Exclusion Criteria:

History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication
History of Grade ≥ 3 hypersensitivity reaction to trastuzumab
History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued
Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment
Require supplemental oxygen for daily activities
Grade ≥ 2 peripheral neuropathy
Bisphosphonate therapy for symptomatic hypercalcemia
Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment
Any experimental therapy within 4 weeks of first study treatment
Any major surgical procedure within 4 weeks of first study treatment
History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis
Pregnancy or lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932373

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Scott Holden, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	TDM3569g
Study First Received:	June 30, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00932373 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

HER2-positive breast cancer
MBC
Trastuzumab
Herceptin

Study placed in the following topic categories:

Skin Diseases
Myotonic Dystrophy
Trastuzumab
Breast Neoplasms

Myotonic Dystrophy 1
Myotonia Atrophica
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Trastuzumab
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009