A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00951665 |
Recruitment Status :
Completed
First Posted : August 4, 2009
Results First Posted : June 24, 2016
Last Update Posted : June 24, 2016
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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: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Metastatic Breast Cancer |
Interventions |
Drug: paclitaxel Drug: pertuzumab [Perjeta] Drug: trastuzumab emtansine [Kadcyla] |
Enrollment | 107 |
Participant Flow
Recruitment Details | This study was conducted from 21 Jul 2009 to 04 Jun 2013 at 5 centers (4 centers for Phase Ib and 5 centers for Phase IIa) in the United States. |
Pre-assignment Details |
Arm/Group Title | Phase Ib Regimen 1 | Phase Ib Regimen 2 | Phase Ib Regimen 3 | Phase Ib Regimen 4 | Phase IIa Group A | Phase IIa Group B |
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Participants received trastuzumab emtansine (T-DM1) every three weeks (Q3W) + paclitaxel weekly (QW) intravenously. | Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously. | Participants received T-DM1 QW + paclitaxel QW intravenously. | Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously. | Participants received maximum tolerated dose (MTD) from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously. | Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously. |
Period Title: Phase 1b | ||||||
Started | 29 | 10 | 21 | 3 | 0 | 0 |
Started Treatment | 26 | 10 | 21 | 3 | 0 | 0 |
Completed | 7 | 6 | 4 | 2 | 0 | 0 |
Not Completed | 22 | 4 | 17 | 1 | 0 | 0 |
Reason Not Completed | ||||||
Adverse Event | 2 | 1 | 0 | 1 | 0 | 0 |
Death | 1 | 0 | 2 | 0 | 0 | 0 |
Physician Decision | 4 | 0 | 1 | 0 | 0 | 0 |
Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 |
Disease Progression | 13 | 2 | 14 | 0 | 0 | 0 |
Protocol Violation | 2 | 0 | 0 | 0 | 0 | 0 |
Period Title: Phase 2a | ||||||
Started | 0 | 0 | 0 | 0 | 22 | 22 |
Completed | 0 | 0 | 0 | 0 | 10 | 15 |
Not Completed | 0 | 0 | 0 | 0 | 12 | 7 |
Reason Not Completed | ||||||
Adverse Event | 0 | 0 | 0 | 0 | 2 | 0 |
Death | 0 | 0 | 0 | 0 | 1 | 1 |
Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 |
Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 0 |
Disease Progression | 0 | 0 | 0 | 0 | 6 | 5 |
Baseline Characteristics
Arm/Group Title | Phase Ib Regimen 1 | Phase Ib Regimen 2 | Phase Ib Regimen 3 | Phase Ib Regimen 4 | Phase IIa Group A | Phase IIa Group B | Total | |
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Participants received T-DM1 Q3W + paclitaxel QW intravenously. | Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously. | Participants received T-DM1 QW + paclitaxel QW intravenously. | Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously. | Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously. | Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously. | Total of all reporting groups | |
Overall Number of Baseline Participants | 26 | 10 | 21 | 3 | 22 | 22 | 104 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 26 participants | 10 participants | 21 participants | 3 participants | 22 participants | 22 participants | 104 participants | |
53.3 (12.3) | 51.3 (11.9) | 54.1 (8.5) | 49.3 (4.0) | 51.7 (11.8) | 55.1 (7.7) | 53.2 (10.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 26 participants | 10 participants | 21 participants | 3 participants | 22 participants | 22 participants | 104 participants | |
Female |
26 100.0%
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10 100.0%
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19 90.5%
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3 100.0%
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21 95.5%
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22 100.0%
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101 97.1%
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Male |
0 0.0%
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0 0.0%
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2 9.5%
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0 0.0%
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1 4.5%
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0 0.0%
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3 2.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
Given the small sample size in the different patient subsets, no formal hypothesis testing was performed, and all statistical analyses should be considered descriptive and hypothesis-generating only.
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: | Roche Trial Information Hotline |
Organization: | F. Hoffmann-La Roche AG |
Phone: | +41 61 6878333 |
EMail: | global.trial_information@roche.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT00951665 |
Other Study ID Numbers: |
TDM4652g GO01355 ( Other Identifier: Hoffmann-La Roche ) |
First Submitted: | August 3, 2009 |
First Posted: | August 4, 2009 |
Results First Submitted: | January 4, 2016 |
Results First Posted: | June 24, 2016 |
Last Update Posted: | June 24, 2016 |