Multicentre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Three Standard of Care Regimens for The Treatment of Triple-Negative Breast Cancer in the Neoadjuvant/Adjuvant Setting (REaCT-TNBC)
NCT ID: NCT02688803
Last Updated: 2025-12-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2016-08-30
2017-10-31
Brief Summary
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TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. Clinically, patients with TNBC have a poorer prognosis compared to patients diagnosed with other breast cancer subtypes. Because of the aggressive phenotype and due to observations that systemic chemotherapy offers significantly higher benefit in ER negative disease, current treatment guidelines from provincial and other organizations recommend that patients receive adjuvant systemic chemotherapy for any TNBC greater than 0.5 cm in greatest diameter or node positive independent of primary tumor size.
Currently, there is no world-wide standard recommended chemotherapy regimen for the management of TNBC in the neoadjuvant/adjuvant setting, with treatments varying from region and institution.
As physicians do not know what the "best" treatment for patients is, genuine uncertainty ("clinical equipoise") exists. Physicians will choose between different "standards" in their personal practice, using idiosyncratic decision making processes, without the physician or the patient knowing the optimal option. This is not good for patients, physicians and society as a whole. Determining the optimal treatment remains an important medical issue for patients, physicians and society. This study will survey opinions on a novel method to allow comparisons of established standard of care prophylactic treatment using the "integrated consent model" as part of a pragmatic clinical trial and attempt to compare head to head standard chemotherapy regimens in patients with TNBC.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Dose dense AC-P
Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC-P
(doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Dose dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
FEC-D
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
FEC-D
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
Interventions
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Dose dense AC-P
(doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
FEC-D
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned for chemotherapy
* ≥18 years of age
* Able to provide verbal consent
* Willing to complete a survey
Exclusion Criteria
* Contraindication to one or more of the chemotherapy agents being evaluated in the study
18 Years
FEMALE
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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John Hilton, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Countries
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References
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Jacobs C, Clemons M, Mazzarello S, Hutton B, Joy AA, Brackstone M, Freedman O, Vandermeer L, Ibrahim M, Fergusson D, Hilton J. Enhancing accrual to chemotherapy trials for patients with early stage triple-negative breast cancer: a survey of physicians and patients. Support Care Cancer. 2017 Jun;25(6):1881-1886. doi: 10.1007/s00520-017-3580-4. Epub 2017 Jan 27.
Hilton J, Stober C, Mazzarello S, Vandermeer L, Fergusson D, Hutton B, Clemons M. Randomised feasibility trial to compare three standard of care chemotherapy regimens for early stage triple-negative breast cancer (REaCT-TNBC trial). PLoS One. 2018 Jul 24;13(7):e0199297. doi: 10.1371/journal.pone.0199297. eCollection 2018.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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The Rethinking Clinical Trials (REaCT) website
Other Identifiers
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20160078-01H
Identifier Type: -
Identifier Source: org_study_id
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