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NCT05721248
The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients With HER2+ Metastatic Breast Cancer
Phase 2 trial testing Cessation of anti-HER2 treatment in Breast Cancer in 82 participants. Participants enrolled and being followed up; not accepting new ones.
1 June 2026
Quick facts
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 19 April 2023 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 June 2036 |
| Sites | 13 locations across United States |
Drugs / interventions tested
- Cessation of anti-HER2 treatment
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
- HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →
Sponsor
Dana-Farber Cancer Institute
Who can join
18 and older, any sex, with Breast Cancer or Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
1-year progression-free survival (PFS) Stopped Anti-HER2 Treatment
Time frame: Up to 1 year
The primary endpoint is one-year progression-free survival (PFS) per RECIST 1.1 assessed separately in the participants who agree to stop HER2 therapy and those who continue HER2 therapy. -
1-year progression-free survival (PFS) Continued Anti-HER2 Treatment
Time frame: Up to 1 year
The primary endpoint is one-year progression-free survival (PFS) per RECIST 1.1 assessed separately in the participants who agree to stop HER2 therapy and those who continue HER2 therapy.
Sponsor's own description
This study is being done to see if anti-HER2 treatment be safely stopped in patients with HER2-positive metastatic breast cancer (MBC) that have had exceptional response to treatment. Exceptional response" is considered as cancer progression being controlled for three years or more since starting anti-HER2 treatment.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Management of patients with advanced-stage HER2-positive breast cancer: current evidence and future perspectives.
Marra A, Chandarlapaty S, Modi S. · · 2024 · cited 79× · PMID 38191924 · DOI 10.1038/s41571-023-00849-9 -
Standard-of-Care Treatment for HER2+ Metastatic Breast Cancer and Emerging Therapeutic Options.
Premji SK, O'Sullivan CC. · · 2024 · cited 9× · PMID 38410761 · DOI 10.1177/11782234241234418 -
Clinico-pathological predictors of radiologic complete response to first-line anti-HER2 therapy in metastatic breast cancer.
Cucciniello L, Blondeaux E, Bighin C, Gasparro S, et al · · 2024 · cited 3× · PMID 39695115 · DOI 10.1038/s41523-024-00713-8 -
Real-World Evidence of Long-Term Disease Control in HER2-Positive Metastatic Breast Cancer Patients Treated with a First-Line Combination of Trastuzumab and/or Pertuzumab Plus Chemotherapy.
Chaigneau L, Lapp E, Jai T, Dobi E, et al · · 2025 · PMID 41228325 · DOI 10.3390/cancers17213532
Verify or expand the search:
- PubMed search for NCT05721248
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Dana-Farber Cancer Institute 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 NCT05721248 (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 Dana-Farber Cancer Institute
- Last refreshed: 18 February 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/NCT05721248.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing