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NCT06876714
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
Phase 3 trial testing Trastuzumab (Herceptin) in Anatomic Stage I Breast Cancer AJCC v8 in 1,524 participants. Currently enrolling.
13 March 2028
Quick facts
| Lead sponsor | Alliance for Clinical Trials in Oncology |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,524 |
| Start date | 17 September 2025 |
| Primary completion | 13 March 2028 |
| Estimated completion | 13 March 2037 |
| Sites | 596 locations across Puerto Rico, United States |
Drugs / interventions tested
- Trastuzumab (Herceptin) (trastuzumab-herceptin) — full drug profile →
- Pertuzumab (pertuzumab) — full drug profile →
- Echocardiography
- Multigated Acquisition Scan
- Mammography
- Ultrasound
- Magnetic Resonance Imaging
- Biospecimen Collection — full drug profile →
- Questionnaire Administration
Conditions studied
- Anatomic Stage I Breast Cancer AJCC v8 — all drugs for Anatomic Stage I Breast Cancer AJCC v8 →
- Anatomic Stage II Breast Cancer AJCC v8 — all drugs for Anatomic Stage II Breast Cancer AJCC v8 →
- Early Stage Breast Carcinoma — all drugs for Early Stage Breast Carcinoma →
Sponsor
Alliance for Clinical Trials in Oncology
Who can join
18 and older, any sex, with Anatomic Stage I Breast Cancer AJCC v8 or Anatomic Stage II Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Can neoadjuvant chemotherapy be replaced with immune checkpoint blockade combined with dual anti-HER2 antibodies for HER2-enriched breast cancer?
Bear HD. · · 2026 · PMID 42170572 · DOI 10.21037/tbcr-25-57
Verify or expand the search:
- PubMed search for NCT06876714
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Trastuzumab (Herceptin)
Trials testing the same drug.
- NCT07527806 — Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Im · Phase 2 · not yet recruiting
- NCT07193394 — Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer · Phase 2 · recruiting
- NCT06663787 — Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response b · active not recruiting
Other recruiting trials for Anatomic Stage I Breast Cancer AJCC v8
Currently open trials in the same condition.
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Other Alliance for Clinical Trials in Oncology trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06876714 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06876714.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing