Back to resultsPhase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Triple-Negative Breast Cancer
Primary Purpose
Triple-negative Breast Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IMMU-132 infusion is administered to participants in one arm for the study
IMMU-132 plus Carboplatin infusion
Sponsored by
About this trial
This is an interventional treatment trial for Triple-negative Breast Cancer focused on measuring Antibody drug conjugate, IMMU-132, Triple-negative breast cancer, Safety and tolerability, Progression Free Survival (PFS)
Eligibility Criteria
Inclusion Criteria:
- Female subjects with triple negative metastatic breast cancer, age 18 years or older, pathologically confirmed metastatic adenocarcinoma of the breast. Pathologically confirmed as triple-negative, measurable disease, defined by (RECIST 1.1) guidelines;
- Two or more prior chemotherapy, immunotherapy and/or monoclonal antibody therapy for the treatment of the subjects' metastatic breast cancer;
- Prior neoadjuvant or adjuvant chemotherapy must have been completed at least 4 weeks before start of study treatment with all related toxicities resolved;
- Prior radiotherapy must have completed at least 2 weeks before randomization, with full recovery;
- At least 4 weeks from major surgery, ECOG performance status 0-1.
- Hematology parameters (ANC) ≥ 1500/mm2;
- Platelets ≥ 100,000/mm2;
- Hemoglobin (Hgb) ≥ 9 g/dL AST & ALT ≤ 2.5 x ULN);
- If hepatic metastases present ≤ 5.0 x ULN Total bilirubin ≤ ULN ;
- Subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN;
- Alkaline phosphatase ≤ 2.5 x ULN (unless bone metastases are present in the absence of liver metastasis);
- Creatinine clearance > 60 mL/min
Exclusion Criteria:
- Male subjects with triple negative metastatic breast cancer;
- Concurrent chemotherapy, immunotherapy or monoclonal antibody or any other anti-tumor therapy for breast cancer,
- Concurrent or prior anticoagulation therapy within 7 days of first dose of study treatment,
- History of, or known current evidence of brain metastasis, including leptomeningeal involvement;
- Subjects with bone as the only site of metastatic disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IMMU-132
IMMU-132 plus Carboplatin
Arm Description
IMMU-132 infusion is administered
IMMU-132 infusion and Carboplatin infusion are administered to the participants in this arm of study.
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02161679
Brief Title
Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Triple-Negative Breast Cancer
Official Title
Randomized Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Relapsed/Refractory Triple-Negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
FDA asked to administratively split from IND115621- to open a new IND you need to file a protocol we only drafted it to get the IND open - never initiated
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
5. Study Description
Brief Summary
This is a Phase II, open-label study that evaluates the safety and efficacy of IMMU-132 alone and in combination with carboplatin in patients with triple-negative breast cancer. IMMU132 will be administered once-weekly for the first 2 weeks of 3-week treatment cycles. For those patients assigned to also receive carboplatin, will receive it on the same schedules starting 30 minutes after the completion of IMMU-132 administration. Patients may receive up to a maximum total of 8 cycles.
Detailed Description
The primary objective is to evaluate the safety and efficacy of IMMU-132 alone and in combination with carboplatin administered in 3-week treatment cycles for up to 8 cycles, in patients with triple-negative breast cancer that have received at least two prior treatments. The secondary objectives are to obtain data concerning pharmacokinetics, and immunogenicity.
This is a multi-center study. Eighty patients are planned to be enrolled, with an equal distribution between the two groups. All patients will receive a starting dose of IMMU-132administered once-weekly for the first 2 weeks of 3-week treatment cycles. For those patients assigned to also receive carboplatin, carboplatin will also be administered on the same schedules starting 30 minutes after the completion of IMMU-132 administration. Patients may receive up to a maximum total of 8 cycles (16 doses), but patients with a complete response, partial response or stable disease at that time, or patients who had achieved an objective response, but relapsed after discontinuing treatment, may continue to be treated based on physician discretion. Follow up is then required until resolution or stabilization of any treatment-related toxicity, and patients with stable disease or objective responses must also continue evaluations until survived.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-negative Breast Cancer
Keywords
Antibody drug conjugate, IMMU-132, Triple-negative breast cancer, Safety and tolerability, Progression Free Survival (PFS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMMU-132
Arm Type
Experimental
Arm Description
IMMU-132 infusion is administered
Arm Title
IMMU-132 plus Carboplatin
Arm Type
Active Comparator
Arm Description
IMMU-132 infusion and Carboplatin infusion are administered to the participants in this arm of study.
Intervention Type
Drug
Intervention Name(s)
IMMU-132 infusion is administered to participants in one arm for the study
Intervention Type
Drug
Intervention Name(s)
IMMU-132 plus Carboplatin infusion
Other Intervention Name(s)
IMMU-132 and Carboplatin infusions are administered to the participants in this arm of study
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female subjects with triple negative metastatic breast cancer, age 18 years or older, pathologically confirmed metastatic adenocarcinoma of the breast. Pathologically confirmed as triple-negative, measurable disease, defined by (RECIST 1.1) guidelines;
Two or more prior chemotherapy, immunotherapy and/or monoclonal antibody therapy for the treatment of the subjects' metastatic breast cancer;
Prior neoadjuvant or adjuvant chemotherapy must have been completed at least 4 weeks before start of study treatment with all related toxicities resolved;
Prior radiotherapy must have completed at least 2 weeks before randomization, with full recovery;
At least 4 weeks from major surgery, ECOG performance status 0-1.
Hematology parameters (ANC) ≥ 1500/mm2;
Platelets ≥ 100,000/mm2;
Hemoglobin (Hgb) ≥ 9 g/dL AST & ALT ≤ 2.5 x ULN);
If hepatic metastases present ≤ 5.0 x ULN Total bilirubin ≤ ULN ;
Subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN;
Alkaline phosphatase ≤ 2.5 x ULN (unless bone metastases are present in the absence of liver metastasis);
Creatinine clearance > 60 mL/min
Exclusion Criteria:
Male subjects with triple negative metastatic breast cancer;
Concurrent chemotherapy, immunotherapy or monoclonal antibody or any other anti-tumor therapy for breast cancer,
Concurrent or prior anticoagulation therapy within 7 days of first dose of study treatment,
History of, or known current evidence of brain metastasis, including leptomeningeal involvement;
Subjects with bone as the only site of metastatic disease.
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Triple-Negative Breast Cancer
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