Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy
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|ClinicalTrials.gov Identifier: NCT04928261|
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : May 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Trastuzumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Multicentre, Pragmatic Trial Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy (REaCT-HER TIME)|
|Actual Study Start Date :||December 13, 2021|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: De-escalated HER2 targeted treatment
Patients with early-stage HER2-positive breast cancer who demonstrate a pathological complete response at time of surgery.
Patients with early-stage HER2-positive breast cancer who demonstrate a pathological complete response at time of surgery will be treated with HER2 targeted therapy for a total of 9 treatments every 3 weeks (or its equivalent if given weekly) including the treatment received preoperatively.
Other Name: Herceptin
- Multiple site activation [ Time Frame: 1 year after first participant is accrued ]Evaluating the feasibility of multiple Canadian site activation within the first year of study accrual. Achieved by the activation of at least 4 Canadian sites within 1 year of the first patient being accrued into the study.
- Medical oncologist active participation [ Time Frame: Through to end of accrual - average 2 years ]Evaluating the number of medical oncologists at each study site who actively participate in the trial. Active participation includes approaching eligible patients for the study, as well as following up with the patients who are taking part in the study.
- Enrolment of at least 50 participants across all sites within 9 months of the fourth site accruing its first participant [ Time Frame: 9 months after fourth site accrues first participant ]Enrolment of at least 50 participants across all sites within 9 months of the fourth site accruing its first participant.
- Cardiac events [ Time Frame: 3 years after study enrolment ]Cardiac events defined as death from a cardiac or heart failure of New York Heart Association (NYHA) class III or IV, or with a decrease in the left ventricular ejection fraction of at least 10 percentage points from baseline to a value of less than 50%. Cardiac monitoring will be assessed as per physician standards
- Rate of HER2-positive treatment discontinuation [ Time Frame: 6 months after study enrolment ]De-escalated HER2-positive treatment discontinuation and the reasons why treatment was discontinued
- Health-related quality of life [ Time Frame: Baseline, 3, 6, 12 and 36 months after study enrolment ]Health-related quality of life measure using the EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire.
- Incremental cost-effectiveness ratios [ Time Frame: 3 years from study enrolment ]The difference in cost between 6 months of HER2-positive therapy versus the standard 12 months of HER2-positive therapy.
- Disease free survival [ Time Frame: 3 years from study enrolment ]Disease Free Survival (DFS), defined as the percentage of people in the trial who are alive and disease-free (no local invasive breast cancer recurrence, new local invasive breast cancer) at 3 years
- Overall survival [ Time Frame: 3 years from study enrolment ]Overall Survival (OS), defined as the number of people alive, with or without signs of cancer at 3 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04928261
|Contact: Lisa Vandermeer, MSc||6137377700 ext firstname.lastname@example.org|
|Contact: Michelle Liu||613-737-7700 ext email@example.com|
|The Ottawa Hospital Cancer Centre||Recruiting|
|Ottawa, Ontario, Canada, K1H8M2|
|Contact: Lisa Vandermeer 6137377700 ext 73039 firstname.lastname@example.org|
|Principal Investigator: Sharon McGee, MD|
|Principal Investigator:||Sharon McGee, MD||Ottawa Hospital Research Institute|