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NCT06876714 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,524
- Enrollment target
- 20
- Study locations
NCT06876714: Recruiting Phase 3 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
NCT06876714 is a Phase 3 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8 that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 1,524 participants, above the 335-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (355% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06876714, a Phase 3 study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,524 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The Kaplan-Meier method will be used to estimate the distribution of RFS times and a stratified log-rank test for non-inferiority will be used to assess whether RFS with 6 total months of human epidermal growth factor receptor 2 (HER2)-blockade is non-inferior to standard-of-care 12 total months of HER2-blockade in this patient population. Stratified Cox modeling will be used to estimate the hazard ratio and corresponding one-sided 95% confidence interval (CI).
Conditions Studied
Interventions
- PROCEDURE Echocardiography
- PROCEDURE Multigated Acquisition Scan
- PROCEDURE Mammography
- BIOLOGICAL Trastuzumab (Herceptin)
- BIOLOGICAL Pertuzumab
Study Locations (20)
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Enloe Medical Center - Chico
- Kaiser Permanente Dublin - Dublin
- Mercy Cancer Center - Elk Grove - Elk Grove
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente Fresno Orchard Plaza - Fresno
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- Fremont - Rideout Cancer Center - Marysville
- Mercy Cancer Center - Merced
- Kaiser Permanente- Modesto MOB II - Modesto
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Mercy Cancer Center - Rocklin - Rocklin
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CARTI Cancer Center - Little Rock
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,524 participants |
| Start Date | 2025-09-17 |
| Est. Completion | 2037-03-13 |
| Phase | Phase 3 |
What NCT06876714 shows while recruiting
NCT06876714 is an interventional study that assigns participants to a tested intervention. Its 1,524 participants enrollment target places it among the larger protocols in the corpus, above the 335-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (355% higher).
The record links to 3 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Echocardiography is the first listed.
NCT06876714 names 20 study sites across 3 states, led by California, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT06876714 about?
NCT06876714 is a clinical study titled "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". 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) chemotherap...
What is the current status of trial NCT06876714?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,524 participants. The study started on 2025-09-17. Estimated completion is 2037-03-13.
What conditions does trial NCT06876714 study?
This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Early Stage Breast Carcinoma.
What interventions are being tested in trial NCT06876714?
The interventions under investigation include: Echocardiography (PROCEDURE), Multigated Acquisition Scan (PROCEDURE), Mammography (PROCEDURE), Trastuzumab (Herceptin) (BIOLOGICAL), Pertuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06876714?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06876714 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06876714's enrollment target sits among peer trials
1,524 4th of 73 higher than 70 of 73 other Anatomic Stage II Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage II Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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