Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects
Public ClinicalTrials.gov record NCT01516307. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01516307
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 349 participants
Conditions and interventions
Conditions
Interventions
- OPT-822/OPT-821(30 μg/100 μg) Biological
- Phosphate Buffer Saline (PBS) Biological
- Cyclophosphamide Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2011
- Primary completion
- Jul 31, 2016
- Completion
- Jul 31, 2019
- Last update posted
- Sep 15, 2020
2011 – 2019
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35294 | — |
| St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center | Fullerton | California | 92835 | — |
| University of California, San Diego (UCSD) | La Jolla | California | 92093 | — |
| University of California, Irvine (UCI) | Orange | California | 92868 | — |
| University of California, San Francisco (UCSF) | San Francisco | California | 94115 | — |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | — |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | — |
| University of California, Los Angeles (UCLA) | Santa Monica | California | 90404 | — |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Hope Women's Cancer Center | Asheville | North Carolina | 28801 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01516307, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 15, 2020 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01516307 live on ClinicalTrials.gov.