Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer
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ClinicalTrials.gov Identifier: NCT02101385 |
Recruitment Status
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Recruiting
First Posted
: April 2, 2014
Last Update Posted
: February 8, 2018
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Tracking Information | |||||||||
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First Submitted Date ICMJE | March 21, 2014 | ||||||||
First Posted Date ICMJE | April 2, 2014 | ||||||||
Last Update Posted Date | February 8, 2018 | ||||||||
Actual Study Start Date ICMJE | March 2014 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Two-Year Disease-Free Survival (DFS) Rate [ Time Frame: 24 months ] To compare 2-year disease-free survival (DFS) in participants with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT02101385 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer | ||||||||
Official Title ICMJE | A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158 | ||||||||
Brief Summary | This study will test the theory that therapy designed for each individual's tumor will improve outcomes over standard of care in a population that needs a better standard. | ||||||||
Detailed Description | OUTLINE: This is a multi-center trial. SEQUENCING: DNA from archived tumor samples collected at the time of surgery (residual disease post neoadjuvant chemotherapy) will be extracted and sequenced. The resulting sequencing data will be interrogated for known genomic drivers of sensitivity or resistance to existing FDA approved agents. CANCER GENOMICS TUMOR BOARD (CGTB): Realizing that optimal treatment recommendations cannot be made based on sequencing data alone, the CGTB will be responsible for the final treatment recommendation. The CGTB will consider the genomic data along with the patient's prior treatment history, ongoing toxicities, and comorbidities. Preference will be given to the treatment identified by the sequencing data unless a significant clinical or safety contraindication exists for that therapy. All participants and investigators will be blinded to sequencing results and CGTB deliberations until the time of relapse. PARTICIPANTS WITH A CGTB TREATMENT RECOMMENDATION: Participants with a CGTB recommendation will be randomized to Experimental Arm A (genomically directed monotherapy) or Control Arm B (standard therapy). EXPERIMENTAL ARM A (GENOMICALLY DIRECTED MONOTHERAPY): Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). Clinical and laboratory monitoring and dose-reductions will follow the FDA package insert guidelines. TOP GENOMIC ACTIONABLE BIOMARKERS/PATHWAYS AND DRUG RECOMMENDATIONS:
CONTROL ARM B (STANDARD THERAPY); Recently, a randomized phase III trial of over 900 HER2-negative patients demonstrated an improvement in disease-free survival (DFS) and overall survival (OS) for the addition of 8 cycles of capecitabine in the post-neoadjuvant setting. The hazard ratios were also significant in the triple negative subgroup. Thus, capecitabine can be considered a standard option in this setting. As this represents only a single trial (with prior data not demonstrating benefit for the addition of capecitabine in the neoadjuvant nor adjuvant settings in unselected patients), observation can be considered an option as directed by the treating physician. While not recommended, other therapies can be used as deemed appropriate by the treating physician. In the event of disease progression on the control arm, patient sequencing results will be forwarded to the treating physician. PARTICIPANTS WITH NO CGTB RECOMMENDATION: Participants may have no CGTB recommendation either because 1) sequencing did not identify a matched drug or 2) the matched drug was contraindicated. These participants will be assigned to Control Arm B and treated as described above for Control Arm B. As the outcome of participants without an 'actionable' genomically directed therapy may differ, the primary analysis will include only participants randomized to Control Arm B. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days prior to study registration Life Expectancy: Not Specified Adequate laboratory values must be obtained within 14 days prior to study registration: Hematopoietic:
Hepatic:
Renal:
Cardiac:
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||||
* 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 |
136 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date | December 2021 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Women of childbearing potential must have a negative pregnancy test within 30 days prior to study registration.
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT02101385 | ||||||||
Other Study ID Numbers ICMJE | BRE12-158 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement |
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Responsible Party | Bryan Schneider, MD, Hoosier Cancer Research Network | ||||||||
Study Sponsor ICMJE | Bryan Schneider, MD | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Hoosier Cancer Research Network | ||||||||
Verification Date | February 2018 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |