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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00932373
First received: June 30, 2009
Last updated: December 14, 2011
Last verified: December 2011
  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 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Frequency and nature of Dose-limiting toxicities (DLTs) [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Frequency and nature of serious adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Nature, severity, and relatedness of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response [ Time Frame: Complete response or partial response as determined on two consecutive occasions ≥ 4 weeks apart ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Time from the initial response to disease progression or death from any cause ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Time from first dose to documented disease progression or death ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: April 2006
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Scott Holden, M.D. Genentech, Inc.
  More Information

No publications provided by Genentech, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00932373     History of Changes
Other Study ID Numbers: TDM3569g
Study First Received: June 30, 2009
Last Updated: December 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
HER2-positive breast cancer
MBC
Trastuzumab emtansine
Herceptin
T-DM1

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Ado-trastuzumab emtansine
Maytansine
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014