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.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
First received: June 30, 2009
Last updated: December 14, 2011
Last verified: December 2011

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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Sponsors and Collaborators
Genentech, Inc.
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
Trastuzumab emtansine

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Ado-trastuzumab emtansine
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 July 27, 2015