A study to compare the study drug IMMU-132 with standard treatments in Metastatic Triple-Negative Breast Cancer patients Who have Received at Least Two Prior Treatments.

Phase 1

Conditions: Relapsed/Refractory Triple-Negative Breast Cancer
MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-003019-21-ES

Lead Sponsor: Immunomedics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 328

Inclusion Criteria

• Female or male patients, >18 years of age, able to understand and give written informed consent.
• Histologically or cytologically confirmed TNBC per ASCO/CAP criteria, based on the most recent analyzed biopsy or other pathology specimen.
• Metastatic disease documented by CT or MRI imaging.
• Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.
• Brain MRI must be done for patients with brain metastasis and patient must have had stable CNS disease for at least 4 weeks
• At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids = 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).
• Refractory to or relapsed after at least two prior standard of care chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer. (These regimens will qualify regardless of triple-negative status at the time they were given. There is no upper limit in the number of prior chemotherapies and earlier adjuvant or neoadjuvant therapy for more limited disease will qualify as one of the required prior regimens if the development of unresectable, locally advanced or metastatic disease occurred within a 12-month period of time after completion of chemotherapy).
• All patients must have been previously treated with a taxane regardless of disease stage (adjuvant, neoadjuvant or advanced) when it was given.
• Eligible for one of the chemotherapy options listed as TPC (Eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.
• ECOG performance score of 0 or 1.
• Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
• Adequate renal and hepatic function (creatinine clearance of > 60 ml/min, may be calculated using Cockcroft-Gault equation; bilirubin = 1.5 IULN, AST and ALT = 3.0 x IULN or 5 x IULN if known liver metastases).
• Recovered from all toxicities to Grade 1 or less by NCI CTCAE v4.00 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Patients with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
• Patients must have completed all prior cancer treatments at least 2 weeks prior to randomization including chemotherapy (includes also endrocrine treatment), radiotherapy and major surgery. Note: Prior antibody treatment for cancer must have been completed at least 3 weeks prior to randomization.
• Prior investigational agents are permitted, provided completion according to the timeframes above.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 263
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

• Women who are pregnant or lactating.
• Women of childbearing potential or fertile men unwilling to use effective contraception during study until conclusion of 4-week post-treatment evaluation period.
• Patients with Gilbert’s disease.
• Presence of bulky disease (defined as any single mass > 7 cm in its greatest dimension).
• Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
• Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
• Known history of unstable angina, MI, or CHF present within 6 months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
• Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months of randomization.
• Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of randomization.
• Infection requiring antibiotic use within one week of randomization.
• Patients with a history of an anaphylactic reaction to irinotecan.
• Other concurrent medical or psychiatric conditions that, in the Investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by progression-free survival (PFS) in patients with metastatic TNBC previously treated with at least two systemic chemotherapy regimens.;Secondary Objective: The secondary objectives of the study are to compare between the two treatment groups for:<br>- Overall Survival (OS)<br>- Independently-determined Objective Response Rate (ORR), duration of response and time to onset of response per RECIST 1.1 criteria<br>- Quality of life<br>- Safety (adverse events, safety laboratories, incidence of dose delays and dose reductions, treatment discontinuations due to adverse events);Primary end point(s): Progression-free survival (PFS) as determined by an independent centralized blinded assessment.;Timepoint(s) of evaluation of this end point: Monitored throughout the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Overall survival (OS)<br>- Objective response rate (ORR), duration of response, and time to onset of response<br>- Quality of life<br>- Safety, including: adverse events; safety laboratories and evaluations; incidence of dose delays and dose reductions; and treatment discontinuations due to adverse events;Timepoint(s) of evaluation of this end point: Monitored throughout the study

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