Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects
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|ClinicalTrials.gov Identifier: NCT01516307|
Recruitment Status : Active, not recruiting
First Posted : January 24, 2012
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Biological: OPT-822/OPT-821(30 μg/100 μg) + Cyclophosphamide Biological: Phosphate Buffer Saline (PBS) + Cyclophosphamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||349 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2019|
Experimental: OPT-822/OPT-821 (30 μg/100 μg) +Cyclophosphamide
Patients will be randomized 2:1 to receive OPT-822/OPT-821(30 μg/100 μg) plus Cyclophosphamide IV (300mg/m2).
Biological: OPT-822/OPT-821(30 μg/100 μg) + Cyclophosphamide
Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. OPT-822 and OPT-821 are combined at time of injection.
Placebo Comparator: Phosphate Buffer Saline (PBS) + Cyclophosphamide
Patients will receive Phosphate Buffer Saline (PBS) plus Cyclophosphamide IV (300mg/m2).
Biological: Phosphate Buffer Saline (PBS) + Cyclophosphamide
Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.
- Progression Free Survival (PFS) [ Time Frame: Progression or up to 2 years ]
- Overall Survival (OS) [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516307
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