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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

StatusActive, Not Recruiting
PhasePhase 4
Started2021-12-13
View on ClinicalTrials.gov ↗

Amendment history

2026-06-15
minor
Study Status v8
Re-verified, no change to tracked fields
2026-01-20
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations, References v7
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2025-12→confirmed 2025-12-15
Enrollment targetestimated 50→confirmed 52
Study sitesdetails revised at 1 of 1 site
2025-06-20
minor
Study Status, Contacts/Locations v6
Primary completion date2025-09→2025-12
Completion date2025-09→2028-12
Study sitescontacts updated at 1 of 1 site
2023-11-30
notable
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusActive, Not Recruiting→Recruiting
Enrollment target20→50
Study sitesdetails revised at 1 of 1 site
2023-11-01
minor
Study Status v4
Primary completion date2023-09→2025-09
Completion date2023-09→2025-09
Show 3 earlier versions
2023-03-01
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 50→confirmed 20
Study sitesdetails revised at 1 of 1 site
2022-04-26
minor
Study Status, Oversight v2
Re-verified, no change to tracked fields
2021-12-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-08→confirmed 2021-12-13
Study sites0→1
2021-06-15
minor
Original filing
The activity of trastuzumab in early-stage, HER2-positive breast cancer, has been demonstrated in many studies, with meta-analyses showing that in combination with a variety of chemotherapy backbones, trastuzumab reduces the risk of recurrence by nearly half, and death by a third. However, treatment with trastuzumab can result in cardiotoxicity, including heart failure, as well as the significant cost of treatment and the requirement for patients to attend the chemotherapy unit for treatment every 3 weeks for one year. Therefore there has been increasing interest in identifying which patients can safely have less treatment. The investigators therefore propose a real-world, single arm, multicentre trial evaluating 6 months of HER2 targeted therapy, for patients with early-stage, HER2 positive breast cancer, who achieve a pathological complete response (pCR) with upfront systemic chemotherapy and HER2 targeted therapy.
Trial Details
NCT Number NCT04928261
Lead Sponsor Ottawa Hospital Research Institute
Conditions Breast Cancer
Enrollment 52 participants
Start Date 2021-12-13
Primary Completion 2025-12-15 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-16