Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04448886 · ClinicalTrials.gov registry record · Phase 2
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
A Phase 2 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by Ana C Garrido-Castro, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 8
- Study locations
NCT04448886: Active Phase 2 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by Ana C Garrido-Castro, MD.
NCT04448886 is a Phase 2 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer that is active but no longer recruiting, run by Ana C Garrido-Castro, MD. The registered enrollment target is 110 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (46% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04448886, a Phase 2 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, is active but no longer recruiting, sponsored by Ana C Garrido-Castro, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 8
- Study locations
Study Summary
This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer. The names of the study interventions involved in this study are: * Sacituzumab govitecan (IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)
Primary Outcome
Compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone. PFS is defined as the time from study randomization to disease progression, according to RECIST 1.1 or medical judgment, the latter based on established clinical parameters, such as rising tumor markers and physical exam evidence of progression, i.e. worsening chest wall disease, or death due to any cause, whichever occurred first. Patients alive without disease progres
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Sacituzumab Govitecan
Study Locations (8)
Massachusetts
- Dana Farber Cancer Institute - Boston
- DFCI @ Foxborough - Foxborough
- DFCI @ Milford Regional Hospital - Milford
- DF/BWCC in Clinical Affiliation with South Shore Hospital - South Weymouth
Georgia
- Emory University/Winship Cancer Institute - Atlanta
Illinois
- University of Chicago Medical Center - Chicago
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Pennsylvania
- University of Pennsylvania-Abramson Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
What the registry record for NCT04448886 still lists
NCT04448886 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (46% lower).
The record links to 4 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04448886 lists 8 locations in 5 states (Massachusetts, Georgia, Illinois).
Frequently Asked Questions
What is clinical trial NCT04448886 about?
NCT04448886 is a clinical study titled "Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC". This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer. The names of the study interventions involved in this study are: * Sacituzumab govitecan (IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)
What is the current status of trial NCT04448886?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2020-09-23. Estimated completion is 2027-06-01.
What conditions does trial NCT04448886 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, HER2-Negative Breast Cancer, Invasive Breast Cancer, HR-Positive Breast Cancer.
What interventions are being tested in trial NCT04448886?
The interventions under investigation include: Pembrolizumab (DRUG), Sacituzumab Govitecan (DRUG).
Who is sponsoring clinical trial NCT04448886?
This trial is sponsored by Ana C Garrido-Castro, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04448886 being conducted?
This trial has 8 study locations across Georgia, Illinois, Massachusetts, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic 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 NCT04448886's enrollment target sits among peer trials
110 59th of 139 higher than 80 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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
-
Nurturing Exercise Routine for Greater Improvement in Zest and Energy on Enhertu
RECRUITING · Phase 2
-
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
RECRUITING · Phase 2
-
Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer
RECRUITING · Phase 2
-
A Study of Surgery and Radiotherapy in People With Breast Cancer
RECRUITING · Phase 2
-
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
RECRUITING · Phase 2
-
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
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
- NCT01530373 · 110 participants · Phase 2
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
- NCT02379377 · 110 participants · Phase 1
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
- NCT02411773 · 110 participants · Phase 1
Sympatholysis in Chronic Kidney Disease
- NCT03190941 · 110 participants · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
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