Clinical trial NCT02688803: 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)
Official title: 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) OTT 15-04
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: HER2 Negative
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.

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.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary TNBC breast cancer
* Planned for chemotherapy
* ≥18 years of age
* Able to provide verbal consent
* Willing to complete a survey

Exclusion Criteria:

* Metastatic disease
* Contraindication to one or more of the chemotherapy agents being evaluated in the study

Primary outcomes:
measure: Percentage of patients who receive chemotherapy in the neoadjuvant/adjuvant setting for TNBC
timeFrame: One year
measure: Participant satisfaction
timeFrame: One year
Secondary outcomes:
measure: Percentage of participants who complete study treatment
timeFrame: One hour
measure: Hospitalization
timeFrame: One year
measure: Treatment delays
timeFrame: One year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: John Hilton, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.