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Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Triple-Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT02161679
Recruitment Status : Unknown
Verified October 2015 by Immunomedics, Inc..
Recruitment status was:  Not yet recruiting
First Posted : June 12, 2014
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

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.

Condition or disease Intervention/treatment Phase
Triple-negative Breast Cancer Drug: IMMU-132 infusion is administered to participants in one arm for the study Drug: IMMU-132 plus Carboplatin infusion Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2016
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Carboplatin

Arm Intervention/treatment
Experimental: IMMU-132
IMMU-132 infusion is administered
Drug: IMMU-132 infusion is administered to participants in one arm for the study
Drug: IMMU-132 plus Carboplatin infusion
Other Name: IMMU-132 and Carboplatin infusions are administered to the participants in this arm of study

Active Comparator: IMMU-132 plus Carboplatin
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 study
Drug: IMMU-132 plus Carboplatin infusion
Other Name: IMMU-132 and Carboplatin infusions are administered to the participants in this arm of study




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT02161679     History of Changes
Other Study ID Numbers: IMMU-132-02
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Immunomedics, Inc.:
Antibody drug conjugate
IMMU-132
Triple-negative breast cancer
Safety and tolerability
Progression Free Survival (PFS)

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Camptothecin
Immunoconjugates
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs