A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00932373 |
Recruitment Status :
Completed
First Posted : July 3, 2009
Results First Posted : July 30, 2015
Last Update Posted : August 26, 2015
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Metastatic Breast Cancer |
Intervention |
Drug: trastuzumab-MCC-DM1 |
Enrollment | 54 |
Participant Flow
Recruitment Details | Approximately four centers in the United States were to participate in the study to enroll approximately 50-60 patients. Between 25 April 2006 and 20 May 2008, 54 patients were enrolled and 52 were treated. |
Pre-assignment Details | Two patients enrolled but discontinued the study prior to receiving study treatment drug, thus 52 patients received at least one dose and are included in the baseline and safety analysis data. |
Arm/Group Title | Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 1.2 mg/kg Weekly | Trastuzumab-MCC-DM1 1.6 mg/kg Weekly | Trastuzumab-MCC-DM1 2.0 mg/kg Weekly | Trastuzumab-MCC-DM1 2.4 mg/kg Weekly | Trastuzumab-MCC-DM1 2.9 mg/kg Weekly |
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Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week | Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week | Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week | Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week | Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week |
Period Title: Overall Study | |||||||||||
Started | 3 | 1 | 1 | 1 | 15 | 3 | 3 | 3 | 3 | 16 | 3 |
Completed | 0 | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 1 | 3 | 0 |
Not Completed | 3 | 1 | 1 | 0 | 14 | 3 | 1 | 3 | 2 | 13 | 3 |
Reason Not Completed | |||||||||||
Progressive disease | 3 | 1 | 0 | 0 | 10 | 1 | 0 | 2 | 1 | 9 | 2 |
Adverse Event | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 0 | 2 | 1 |
Physician Decision | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 |
Dose limiting toxicity | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Clinical progression | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks | Trastuzumab-MCC-DM1 1.2 mg/kg Weekly | Trastuzumab-MCC-DM1 1.6 mg/kg Weekly | Trastuzumab-MCC-DM1 2.0 mg/kg Weekly | Trastuzumab-MCC-DM1 2.4 mg/kg Weekly | Trastuzumab-MCC-DM1 2.9 mg/kg Weekly | Total | |
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Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks | Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week | Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week | Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week | Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week | Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week | Total of all reporting groups | |
Overall Number of Baseline Participants | 3 | 1 | 1 | 1 | 15 | 3 | 3 | 3 | 3 | 16 | 3 | 52 | |
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All summaries were based on data from the safety population (patients who received at least one dose of Trastuzumab-MCC-DM1). All summaries were presented for all patients and by dose level and schedule.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 3 participants | 1 participants | 1 participants | 1 participants | 15 participants | 3 participants | 3 participants | 3 participants | 3 participants | 16 participants | 3 participants | 52 participants | |
60.7 (10.1) | 47.0 (0) | 61.0 (0) | 58.0 (0) | 52.1 (10.3) | 48.0 (6.0) | 55.3 (10.0) | 53.0 (6.1) | 55.3 (3.2) | 50.9 (14.0) | 58.3 (11.0) | 52.9 (10.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 1 participants | 1 participants | 1 participants | 15 participants | 3 participants | 3 participants | 3 participants | 3 participants | 16 participants | 3 participants | 52 participants | |
Female |
3 100.0%
|
1 100.0%
|
1 100.0%
|
1 100.0%
|
15 100.0%
|
3 100.0%
|
3 100.0%
|
3 100.0%
|
3 100.0%
|
16 100.0%
|
3 100.0%
|
52 100.0%
|
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Male |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 3 participants | 1 participants | 1 participants | 1 participants | 15 participants | 3 participants | 3 participants | 3 participants | 3 participants | 16 participants | 3 participants | 52 participants |
3 | 1 | 1 | 1 | 15 | 3 | 3 | 3 | 3 | 16 | 3 | 52 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Medical Communications |
Organization: | Genentech, Inc. |
Phone: | 800 821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT00932373 |
Other Study ID Numbers: |
TDM3569g |
First Submitted: | June 30, 2009 |
First Posted: | July 3, 2009 |
Results First Submitted: | July 1, 2015 |
Results First Posted: | July 30, 2015 |
Last Update Posted: | August 26, 2015 |