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) (OTT15-04)

• ClinicalTrials.gov Identifier: NCT02688803
• Recruitment Status: Completed
• First Posted: February 23, 2016
• Last Update Posted: March 28, 2019
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Dose dense AC-P; Drug: Dose dense AC; Drug: FEC-D	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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 Start Date: August 2016
• Actual Primary Completion Date: October 2017
• Actual Study Completion Date: October 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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)	Drug: 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); Other Names: doxorubicin; cyclophosphamide; paclitaxel
Active Comparator: 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)	Drug: 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); Other Names: doxorubicin; cyclophosphamide; paclitaxel
Active Comparator: 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)	Drug: 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 Names: 5-FU; cyclophosphamide; docetaxel

Outcome Measures

Primary Outcome Measures :

1. Percentage of patients who receive chemotherapy in the neoadjuvant/adjuvant setting for TNBC [ Time Frame: One year ]
   Percentage of patients who receive chemotherapy in the neoadjuvant/adjuvant setting for TNBC compared to the number of participants who after being approached subsequently agree to randomization.
2. Participant satisfaction [ Time Frame: One year ]
   Participant satisfaction survey. Overall participant satisfaction will be determined using the participant survey

Secondary Outcome Measures :

1. Percentage of participants who complete study treatment [ Time Frame: One hour ]
   Percentage of participants who complete study treatment compared to the percentage who discontinue their treatment while on study (compliance) will be calculated using the sites chemotherapy treatment records and data from New Patient Registration.
2. Hospitalization [ Time Frame: One year ]
   Rate of adverse effects requiring hospitalization
3. Treatment delays [ Time Frame: One year ]
   Rate of adverse effects requiring treatment delays

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Ontario

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada, K2H 8L6

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

• Principal Investigator: John Hilton, Dr.; The Ottawa Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT02688803
• Other Study ID Numbers: 20160078-01H
• First Posted: February 23, 2016
• Last Update Posted: March 28, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Ottawa Hospital Research Institute:

HER2 Negative

Additional relevant MeSH terms:

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors