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NCT02648477 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT02648477 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT02648477, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane) in treating patients with triple-negative or hormone-receptor positive breast cancer that has spread from the primary site (place where it started) to other places in the body. Pembrolizumab is an antibody drug that blocks a molecule called programmed death (PD)-1. PD-1 is a molecule that shuts down the body's immune responses and prevents the immune system from attacking the cancer. Doxorubicin hydrochloride is a drug used in chemotherapy that works to stop the growth of tumor cells by stopping them from dividing and by causing them to die. Anti-estrogen therapy, including anastrozole, letrozole, and exemestane, lowers estrogen levels in the body, which may help treat cancer that is hormone receptor-positive. Giving pembrolizumab together with standard treatment of either doxorubicin hydrochloride (triple-negative cancer) or anti-estrogen therapy (hormone receptor-positive cancer) may be an effective treatment for these types of breast cancer.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
- DRUG Doxorubicin Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-03-28 |
| Est. Completion | 2023-12-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02648477
The ClinicalTrials.gov registry entry for NCT02648477 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02648477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02648477 about?
NCT02648477 is a clinical study titled "Pembrolizumab and Doxorubicin Hydrochloride or Anti-Estrogen Therapy in Treating Patients With Triple-Negative or Hormone Receptor-Positive Metastatic Breast Cancer". This phase II trial studies how well pembrolizumab and doxorubicin hydrochloride works compared to pembrolizumab with anti-estrogen therapy (anastrozole, letrozole, or exemestane) in treating patients with triple-negative or hormone-receptor positive breast cancer that has spread from the primary si...
What is the current status of trial NCT02648477?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2016-03-28. Estimated completion is 2023-12-30.
What interventions are being tested in trial NCT02648477?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Doxorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02648477?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
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