Health Condition 1: null- Metastatic Breast Cancer
Conditions
Interventions
Intervention1: OPT-822/OPT-821: 9 doses: 30 µg per dose subcutaneously for 37 weeks
Intervention2: Phosphate Buffer Saline (PBS): 9 doses: 100 µg per dose subcutaneously for 37 weeks
Control Interve
Sponsors
OBI Pharma INC
Clinigene International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female subjects >=21 years of age with histological or cytological diagnosis of breast cancer. 2. Subjects with metastatic breast cancer who have achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of chemotherapy. 3. Subjects must have recovered from toxicities of prior therapies. (i.e. CTCAE - grade 2). 4. Performance status: ECOG - 1 and life expectancy - 3 months. 5. Organ Function Requirements â?? Subjects must have adequate organ functions as defined below: - AST/ALT - AST/ALT ï?£ 5X ULN [with underlying Liver Metastasis] - Total Bilirubin ï?£ 2.0 X ULN - Serum Creatinine ï?£ 1.5X ULN - ANC - 1500 /μL - Platelets > 100,000/μL - No Symptomatic Congestive Heart Failure (Ejection Fraction EF ï?³ 50%) 6. Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines. 7. All positive or negative ER (estrogen receptor), PR (progesterone receptor), HER-2 subjects are eligible for this study. - However, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial. - Subjects who desire to enroll in this study and for whom anti-HER-2 therapy is not available or contraindicated, may be eligible to enroll in this trial. - In countries where continuous anti-HER2 therapy is considered standard of care for HER-2 positive metastatic disease, HER-2 positive subjects are not eligible. 8. Women of childbearing potential must implement adequate contraception in the opinion of the investigator.
Exclusion criteria
Exclusion criteria: 1. Subjects are pregnant or breast-feeding at entry. 2. Subjects with more than 2 events of disease progression (PD) after the development of metastatic breast cancer. 3. Subjects who are currently receiving any other concomitant anticancer therapy with the EXCEPTION of bisphosphonates and hormone therapy. - During the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen. - However, if a change in hormonal therapy is indicated, e.g. due to intolerable adverse effects, the regimen may be modified but change should be minimized thereafter. 4. Subjects with metastasis limited to the bone only and with no history of other visceral or soft tissue metastases. 5. Subjects with evidence or history of CNS metastases. 6. Subjects who have any history of other malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry. 7. Subjects with splenectomy. 8. Subjects with HIV infection. 9. Subjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies. - e.g. Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Graveâ??s disease, Hashimotoâ??s thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc. - Autoimmune disorders confined to the skin (e.g. psoriasis) are eligible, and topical steroids are allowed for the treatment of such skin disorders. 10. Subjects with any known uncontrolled inter-current illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 11. Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization: - Anti-neoplastic agents - Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)] - Immunosuppressants (Cyclosporin, Rapamycin, Tacrolimus, Rituximab, etc.) - Another investigational drug 12. Subjects with pleural effusions and/or ascites requiring paracentesis every 2 weeks or more frequently. 13. Subjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive ingredients in the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) Timepoint: Progression or up to 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS)Timepoint: Time Frame: 5 years | — |
Countries
Hong Kong, India, Other, Taiwan, United States of America
Contacts
Public ContactMr Shijin Rajamani
Outcome results
None listed