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ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab

StatusRecruiting
PhasePhase 3
Started2025-09-17
View on ClinicalTrials.gov ↗

Amendment history

2026-09-01
minor
Study Status, Contacts/Locations v14
Trial sites expanded: 684 → 690 locations
2026-08-04
minor
Study Status, Contacts/Locations v13
Trial sites expanded: 671 → 684 locations
2026-07-01
minor
Study Status, Contacts/Locations v12
Trial sites expanded: 656 → 671 locations
2026-06-04
minor
Study Status, Conditions, Arms and Interventions, Contacts/Locations v11
Study sitesdetails revised at 2 of 656 sites
2026-06-01
minor
Study Status, Contacts/Locations v10
Trial sites expanded: 631 → 656 locations
2026-05-07
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 596 → 631 locations
2026-04-06
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 487 → 596 locations
2026-02-03
minor
Study Status, Contacts/Locations v7
Study sites457→487
2026-01-06
minor
Study Status, Contacts/Locations v6
Study sites402→457
2025-12-02
minor
Study Status, Contacts/Locations v5
Study sites301→402
2025-11-04
minor
Study Status, Contacts/Locations v4
Study sites206→301
2025-10-24
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10-25→confirmed 2025-09-17
Study sitesdetails revised at 206 of 206 sites
2025-09-19
minor
Study Status, Contacts/Locations v2
Study sites0→206
2025-09-05
minor
Study Identification, Study Status v1
Start date2025-03-25→2025-10-25
2025-03-10
minor
Original filing
This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.
Trial Details
NCT Number NCT06876714
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2+ Breast Cancer
Enrollment 1,524 participants
Start Date 2025-09-17
Primary Completion 2028-03-13 (estimated)
Study Completion 2037-03-13 (estimated)
Updated on ClinicalTrials.gov 2026-09-02