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NCT04569747 · ClinicalTrials.gov registry record · Phase 2
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
A Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 375
- Enrollment target
- 20
- Study locations
NCT04569747: Recruiting Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT04569747 is a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 375 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04569747, a Phase 2 study of Breast Cancer and HER2-positive Breast Cancer, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 375 participants
- Enrollment target
- 20
- Study locations
Study Summary
This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer. The study drugs involved in this study are: * A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO) * Hormonal (endocrine) Treatment
Primary Outcome
Kaplan-Meier estimates of iDFS will be estimated and plotted with the corresponding 95% confidence intervals. from the time of randomization until the occurrence of the first of the following events: invasive local/regional recurrence, Contralateral invasive breast cancer, Distant recurrence, Death from any cause
Conditions Studied
Interventions
- COMBINATION_PRODUCT Pertuzumab+TRASTUZUMAB
- DRUG ADJUVANT ENDOCRINE THERAPY
Study Locations (20)
Massachusetts
- Dana Farber Cancer Institite - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Brigham Cancer Center - Foxborough - Foxborough
- Cape Cod Healthcare Center - Hyannis
- Dana-Farber at Milford - Milford
- Dana-Farber at South Shore Hospital - Weymouth
Georgia
- Winship Cancer Institute at Emory University Hospital Midtown - Atlanta
- Emory University - Winship Cancer Institute - Atlanta
- Winship Cancer Institute at Emory Saint Joseph's Hospital - Atlanta
Indiana
- Indiana University Health Schwarz Cancer Center - Indianapolis
- Indiana University Health - Melvin and Bren Simon Cancer Center - Indianapolis
- Indiana University Sidney and Lois Eskenazi Hospital - Indianapolis
New York
- New York University Langone Hospital -Brooklyn - Brooklyn
- New York University Langone Hospital - Long Island - Mineola
- New York University Langone Health - New York
Connecticut
- Stamford Hospital - Stamford
Florida
- University of Miami- Sylvester Comprehensive Cancer Center - Miami
Illinois
- University of Chicago Medical Center - Chicago
Maine
- Eastern Maine Medical Center (Northern Light) - Brewer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2030-09-01 |
| Phase | Phase 2 |
What NCT04569747 shows while recruiting
NCT04569747 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (87% lower).
The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pertuzumab+TRASTUZUMAB is the first listed.
NCT04569747 names 20 study sites across 9 states, led by Massachusetts, Georgia, Indiana.
Frequently Asked Questions
What is clinical trial NCT04569747 about?
NCT04569747 is a clinical study titled "A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer". This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer. The study drugs involved in this study are: * A combination of trastuzumab and pertuzumab given as an...
What is the current status of trial NCT04569747?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 375 participants. The study started on 2021-01-11. Estimated completion is 2030-09-01.
What conditions does trial NCT04569747 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-Positive Breast Cancer, Node Negative Breast Cancer, Invasive Carcinoma of the Breast.
What interventions are being tested in trial NCT04569747?
The interventions under investigation include: Pertuzumab+TRASTUZUMAB (COMBINATION_PRODUCT), ADJUVANT ENDOCRINE THERAPY (DRUG).
Who is sponsoring clinical trial NCT04569747?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04569747 being conducted?
This trial has 20 study locations across Connecticut, Florida, Georgia, Illinois, Indiana. 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 NCT04569747's enrollment target sits among peer trials
375 250th of 1224 higher than 975 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.
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