Triple-negative Breast CancerPhase 2NCT02161679
Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Triple-Negative Breast Cancer
A Phase 2 study testing IMMU-132 infusion is administered to participants in one arm for the study and IMMU-132 plus Carboplatin infusion in people with Triple-negative Breast Cancer, run by Gilead Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- IMMU-132 infusion is administered to participants in one arm for the study and IMMU-132 plus Carboplatin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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.
About this study
Official title: Randomized Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Relapsed/Refractory Triple-Negative Breast Cancer
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.
Read the 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.
- Conditions
- Triple-negative Breast Cancer
- Being tested
- IMMU-132 infusion is administered to participants in one arm for the study, IMMU-132 plus Carboplatin infusion
- Keywords
- Antibody drug conjugate, IMMU-132, Triple-negative breast cancer, Safety and tolerability, Progression Free Survival (PFS)
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMMU-132 infusion is administered to participants in one arm for the studyDrug
IMMU-132 plus Carboplatin infusionDrug
Also called IMMU-132 and Carboplatin infusions are administered to the participants in this arm of study
| Study group | Role | What they receive |
|---|---|---|
| IMMU-132 | Experimental | IMMU-132 infusion is administered Receives: Drug: IMMU-132 infusion is administered to participants in one arm for the study; Drug: IMMU-132 plus Carboplatin infusion |
| IMMU-132 plus Carboplatin | Active comparator | IMMU-132 infusion and Carboplatin infusion are administered to the participants in this arm of study. Receives: Drug: IMMU-132 infusion is administered to participants in one arm for the study; Drug: IMMU-132 plus Carboplatin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startAug 2016
- Primary completionAug 2016
- Study completionAug 2016
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161679
- Sponsor's protocol ID
- IMMU-132-02
- Status last verified
- Sep 2020
- First submitted
- 10 Jun 2014
- Last updated
- 19 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Relapsed/Refractory Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02161679
- Acronym / sponsor ID
- IMMU-132-02
- Conditions
- Triple-negative Breast Cancer
- Keywords
- Antibody drug conjugate, IMMU-132, Triple-negative breast cancer, Safety and tolerability, Progression Free Survival (PFS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMMU-132 | Experimental | Drug: IMMU-132 infusion is administered to participants in one arm for the study, Drug: IMMU-132 plus Carboplatin infusionIMMU-132 infusion is administered |
| IMMU-132 plus Carboplatin | Active comparator | Drug: IMMU-132 infusion is administered to participants in one arm for the study, Drug: IMMU-132 plus Carboplatin infusionIMMU-132 infusion and Carboplatin infusion are administered to the participants in this arm of study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMMU-132 infusion is administered to participants in one arm for the study | Drug | IMMU-132, IMMU-132 plus Carboplatin |
| IMMU-132 plus Carboplatin infusionAlso: IMMU-132 and Carboplatin infusions are administered to the participants in this arm of study | Drug | IMMU-132, IMMU-132 plus Carboplatin |
Primary outcome
Progression Free Survival
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMMU-132 infusion is administered to participants in one arm for the study and IMMU-132 plus Carboplatin infusion in people with Triple-negative Breast Cancer, run by Gilead Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.