Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05721248 · ClinicalTrials.gov registry record · Phase 2
STOP-HER2: Stopping Trastuzumab in HER2+ MBC
A Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 13
- Study locations
NCT05721248: Active Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT05721248 is a Phase 2 study of Breast Cancer and Metastatic Breast Cancer that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 82 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05721248, a Phase 2 study of Breast Cancer and Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 13
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Cessation of anti-HER2 treatment
Study Locations (13)
Massachusetts
- Dana-Farber Cancer Insitute - Boston
- DFCI @ Foxborough - Foxborough
- DFCI @ Merrimack Valley - Methuen
- DFCI @ Milford Regional Hospital - Milford
- DFCI @ South Shore Hospital - South Weymouth
Arizona
- Mayo Clinic Hospital Arizona - Phoenix
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Florida
- Mayo Clinical Hospital Florida - Jacksonville
Minnesota
- Mayo Clinic Rochester - Rochester
North Carolina
- Duke University - Durham
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2023-04-19 |
| Est. Completion | 2036-06 |
| Phase | Phase 2 |
What the registry record for NCT05721248 still lists
NCT05721248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Cessation of anti-HER2 treatment is the first listed.
NCT05721248 lists 13 locations in 9 states (Massachusetts, Arizona, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05721248 about?
NCT05721248 is a clinical study titled "STOP-HER2: Stopping Trastuzumab in HER2+ MBC". 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 an...
What is the current status of trial NCT05721248?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2023-04-19. Estimated completion is 2036-06.
What conditions does trial NCT05721248 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, HER2-positive Breast Cancer.
What interventions are being tested in trial NCT05721248?
The interventions under investigation include: Cessation of anti-HER2 treatment (OTHER).
Who is sponsoring clinical trial NCT05721248?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05721248 being conducted?
This trial has 13 study locations across Arizona, District of Columbia, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05721248's enrollment target sits among peer trials
82 639th of 1224 higher than 582 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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
-
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
RECRUITING · Phase 2
-
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
RECRUITING · Phase 2
-
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
RECRUITING · Phase 2
-
Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
RECRUITING · Phase 2
-
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
RECRUITING · Phase 2
-
Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03319901 · 82 participants · Phase 1
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
- NCT03493425 · 82 participants · Phase 2
Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery
- NCT04105270 · 82 participants · Phase 2
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
- NCT04428658 · 82 participants · NA
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI