NCT02161679

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
2.1 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 19, 2021

Status Verified

September 1, 2020

Enrollment Period

Same day

First QC Date

June 10, 2014

Last Update Submit

August 12, 2021

Conditions

Triple-negative Breast Cancer

Keywords

Antibody drug conjugateIMMU-132Triple-negative breast cancerSafety and tolerabilityProgression Free Survival (PFS)

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    2 years

Study Arms (2)

IMMU-132

EXPERIMENTAL

IMMU-132 infusion is administered

Drug: IMMU-132 infusion is administered to participants in one arm for the studyDrug: 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.

Drug: IMMU-132 infusion is administered to participants in one arm for the studyDrug: IMMU-132 plus Carboplatin infusion

Interventions

IMMU-132 infusion is administered to participants in one arm for the studyDRUG
IMMU-132IMMU-132 plus Carboplatin
IMMU-132 plus Carboplatin infusionDRUG
Also known as: IMMU-132 and Carboplatin infusions are administered to the participants in this arm of study
IMMU-132IMMU-132 plus Carboplatin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 12, 2014

Study Start

August 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 19, 2021

Record last verified: 2020-09