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
ClinicalTrials.gov Identifier:
NCT00932373
First received: June 30, 2009
Last updated: December 14, 2011
Last verified: December 2011

June 30, 2009
December 14, 2011
April 2006
June 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00932373 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
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

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: trastuzumab-MCC-DM1
Intravenous escalating dose
Experimental: 1
Intervention: Drug: trastuzumab-MCC-DM1
Beeram M, Krop IE, Burris HA, Girish SR, Yu W, Lu MW, Holden SN, Modi S. A phase 1 study of weekly dosing of trastuzumab emtansine (T-DM1) in patients with advanced human epidermal growth factor 2-positive breast cancer. Cancer. 2012 Dec 1;118(23):5733-40. doi: 10.1002/cncr.27622. Epub 2012 May 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
August 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00932373
TDM3569g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Scott Holden, M.D. Genentech
Genentech
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP