Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01516307 · ClinicalTrials.gov registry record · Phase 2
Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects
A Phase 2 study of Metastatic Breast Cancer, sponsored by OBI Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 349
- Enrollment target
- 20
- Study locations
NCT01516307 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by OBI Pharma. The registered enrollment target is 349 participants, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT01516307, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by OBI Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 349 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL OPT-822/OPT-821(30 μg/100 μg)
- BIOLOGICAL Phosphate Buffer Saline (PBS)
Study Locations (20)
California
- St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center - Fullerton
- University of California, San Diego (UCSD) - La Jolla
- University of California, Irvine (UCI) - Orange
- University of California, San Francisco (UCSF) - San Francisco
- Coastal Integrative Cancer Care - San Luis Obispo
- Central Coast Medical Oncology Corporation - Santa Maria
- University of California, Los Angeles (UCLA) - Santa Monica
Other
- UNIMED Medical Institute - Hong Kong
- HCG, Bangalore Institute of Oncology - Bengaluru
- Curie Manavata Cancer Centre - Mumbai
- Dong-A University Hospital - Busan
- Pusan National University Hospital - Busan
- Inha University Hospital - Chungcheongbuk-Do
- National Cancer Center - Chungcheongbuk-Do
Alabama
- The University of Alabama at Birmingham (UAB) - Birmingham
Florida
- Memorial Regional Hospital - Hollywood
Illinois
- University of Chicago Medical Center - Chicago
New York
- Weill Cornell Medical College - New York
North Carolina
- Hope Women's Cancer Center - Asheville
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 349 participants |
| Start Date | 2011-12 |
| Est. Completion | 2019-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01516307
The ClinicalTrials.gov registry entry for NCT01516307 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 349 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (73% higher). The listed sponsor is OBI Pharma, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01516307 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Other, Alabama.
Frequently Asked Questions
What is clinical trial NCT01516307 about?
NCT01516307 is a clinical study titled "Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects". The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.
What is the current status of trial NCT01516307?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 349 participants. The study started on 2011-12. Estimated completion is 2019-08.
What conditions does trial NCT01516307 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT01516307?
The interventions under investigation include: Cyclophosphamide (DRUG), OPT-822/OPT-821(30 μg/100 μg) (BIOLOGICAL), Phosphate Buffer Saline (PBS) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01516307?
This trial is sponsored by OBI Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01516307 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, New York. 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.
-
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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.