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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
NCT04569747 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04569747
The ClinicalTrials.gov registry entry for NCT04569747 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 819 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04569747 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Massachusetts, Georgia, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Invasive Carcinoma of the Breast, Node Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04569747?
The interventions under investigation include: Pertuzumab+TRASTUZUMAB (COMBINATION_PRODUCT), ADJUVANT ENDOCRINE THERAPY (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04569747?
This trial is sponsored by Dana-Farber Cancer Institute, which has 819 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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