A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
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ClinicalTrials.gov Identifier: NCT02131064 |
Recruitment Status :
Completed
First Posted : May 6, 2014
Results First Posted : June 8, 2017
Last Update Posted : July 2, 2019
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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 |
Breast Neoplasms |
Interventions |
Drug: Carboplatin Drug: Docetaxel Drug: Pertuzumab Drug: Trastuzumab Drug: Trastuzumab Emtansine |
Enrollment | 444 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | A total of 574 participants were screened at 65 sites in 10 countries, of which 444 participants were randomized in two arms: Trastuzumab (TCH) + Pertuzumab (P) (Arm A) and Trastuzumab Emtansine (TDM1) + P (Arm B) |
Arm/Group Title | TCH + P | T-DM1 + P |
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Arm/Group Description | Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles). | Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period). |
Period Title: Overall Study | ||
Started | 221 | 223 |
Completed | 196 | 189 |
Not Completed | 25 | 34 |
Reason Not Completed | ||
Death | 5 | 6 |
Lost to Follow-up | 4 | 8 |
Withdrawal by Subject | 14 | 18 |
Other | 2 | 2 |
Baseline Characteristics
Arm/Group Title | TCH + P | T-DM1 + P | Total | |
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Arm/Group Description | Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles). | Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period). | Total of all reporting groups | |
Overall Number of Baseline Participants | 221 | 223 | 444 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 221 participants | 223 participants | 444 participants | |
49.3 (11.2) | 50.5 (10.6) | 49.9 (10.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 221 participants | 223 participants | 444 participants | |
Female |
221 100.0%
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222 99.6%
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443 99.8%
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Male |
0 0.0%
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1 0.4%
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1 0.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
The reported results are interim 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: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800 821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02131064 |
Other Study ID Numbers: |
BO28408 TRIO021 ( Other Identifier: Roche ) 2012-004879-38 ( EudraCT Number ) |
First Submitted: | May 2, 2014 |
First Posted: | May 6, 2014 |
Results First Submitted: | December 3, 2016 |
Results First Posted: | June 8, 2017 |
Last Update Posted: | July 2, 2019 |