A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Combination of Trastuzumab and Pertuzumab With or Without Concurrent Taxane Chemotherapy Given for Twelve Weeks in Patients With Operable HER2+/HR- Breast Cancer Within the ADAPT Protocol (ADAPT)
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ClinicalTrials.gov Identifier: NCT01817452 |
Recruitment Status :
Recruiting
First Posted : March 25, 2013
Last Update Posted : March 24, 2023
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Sponsor:
West German Study Group
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
West German Study Group
Tracking Information | |||||||
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First Submitted Date ICMJE | March 18, 2013 | ||||||
First Posted Date ICMJE | March 25, 2013 | ||||||
Last Update Posted Date | March 24, 2023 | ||||||
Actual Study Start Date ICMJE | March 2014 | ||||||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Definition of a biomarker (profile) characterizing "good responders" to dual blockade T and P anti-HER2 blockade that have similar pCR rates as patients treated with identical dual anti-HER2 blockade + taxane backbone [ Time Frame: After 12 weeks of therapy ] pCR will be measured after 12 weeks of randomized treatment.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Combination of Trastuzumab and Pertuzumab With or Without Concurrent Taxane Chemotherapy Given for Twelve Weeks in Patients With Operable HER2+/HR- Breast Cancer Within the ADAPT Protocol | ||||||
Official Title ICMJE | A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Combination of Trastuzumab and Pertuzumab With or Without Concurrent Taxane Chemotherapy Given for Twelve Weeks in Patients With Operable HER2+/HR- Breast Cancer Within the ADAPT Protocol | ||||||
Brief Summary | Trial to evaluate efficacy of dual blockade with two anti-HER2 agents with or without chemotherapy backbone within the ADAPT trial. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
220 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | October 2024 | ||||||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Additional Inclusion criteria for participation in the HR-/HER2+ sub-protocol:
Exclusion Criteria:
Additional Exclusion Criteria for participation in the HER2+/HR- sub-protocol:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01817452 | ||||||
Other Study ID Numbers ICMJE | WSG-AM06 / ADAPT HER2+/HR- | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | West German Study Group | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | West German Study Group | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Roche Pharma AG | ||||||
Investigators ICMJE |
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PRS Account | West German Study Group | ||||||
Verification Date | March 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |