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

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.

Study Overview

• Status: Withdrawn
• Conditions: Triple-negative Breast Cancer
• Intervention / Treatment: Drug: IMMU-132 infusion is administered to participants in one arm for the study; Drug: IMMU-132 plus Carboplatin infusion

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
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: IMMU-132 and Carboplatin infusions are administered to the participants in this arm of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	2 years

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 12, 2014

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Antibody drug conjugate; IMMU-132; Triple-negative breast cancer; Safety and tolerability; Progression Free Survival (PFS)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Phytogenic; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Carboplatin; Immunoconjugates; Camptothecin
• Other Study ID Numbers: IMMU-132-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No