Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by Immunomedics, Inc.
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT02574455
First received: October 8, 2015
Last updated: March 27, 2017
Last verified: March 2017
  Purpose

This is an international, multi-center, open-label, randomized, Phase III study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs to be selected prior to randomization from one of the 4 allowed regimens. Randomization will be stratified by number of prior chemotherapies for advanced disease (2-3 vs > 3) and geographical location (North America vs Europe).

Patients will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor progression leading to treatment withdrawal will be assessed by the investigator. Starting with the initial dose of sacituzumab govitecan or TPC, CT scans (or MRI if contrast allergic) will be obtained at least every 8 weeks until the occurrence of progression of disease requiring discontinuation of further treatment.All patients, including those prematurely terminating study participation, will be followed every 4 weeks during the first year and every 8 weeks thereafter for survival follow-up.


Condition Intervention Phase
Breast Cancer
Drug: Sacituzumab govitecan
Drug: Eribulin
Drug: Capecitabine
Drug: Gemcitabine
Drug: Vinorelbine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • Progression-Free Survival (PFS): [ Time Frame: 3 YEARS ]
    PFS


Secondary Outcome Measures:
  • Overall Survival (OS): [ Time Frame: 3 YEARS ]

    OS will compared between the two treatment groups.

    PFS will be measured by an independent centralized and blinded group of radiology experts who will be assessing tumor response using RECIST 1.1 criteria. FDA definitions and guidance as described in Guidance for Industry:


  • Objective Response Rate [ Time Frame: 3 years ]
    ORR will compared between the two treatment groups.

  • Duration of Response [ Time Frame: 3 years ]
    Duration of response will compared between the two treatment groups.

  • Time to Onset of response [ Time Frame: 3 years ]
    Time to onset of response will compared between the two treatment groups.


Estimated Enrollment: 328
Anticipated Study Start Date: March 31, 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMMU-132
Sacituzumab govitecan (10 mg/kg on Days 1 and 8 of 21-day cycles)
Drug: Sacituzumab govitecan
Sacituzumab govitecan (10 mg/kg on Days 1 and 8 of 21-day cycles)
Other Name: IMMU-132
Active Comparator: Control Arm

Treatment of Physician's Choice determined before randomization from only one of the following treatments (see Appendix 2 for more details on administration and dosing management):

Eribulin (1.4 mg/m2 intravenously on Days 1 and 8 of a 21-day cycle). Capecitabine (1250 mg/m2 orally twice day for 2 weeks followed by a 1 week rest period given as a 21-day cycle).

Gemcitabine (1250 mg/m2 intravenously on Days 1 and 8 of a 21-day cycle). Vinorelbine (30 mg/m2 weekly; IV injection over 6-10 min) No combination of the four choices is permitted

Drug: Eribulin
Eribulin (1.4 mg/m2 intravenously on Days 1 and 8 of a 21-day cycle)
Other Name: Halaven
Drug: Capecitabine
Capecitabine (1250 mg/m2 orally twice daily for 2 weeks followed by a 1 week rest period given as a 21-day cycle)
Other Name: Xeloda
Drug: Gemcitabine
Gemcitabine (1250 mg/m2 intravenously on Days 1 and 8 of a 21-day cycle)
Other Name: Gemzar
Drug: Vinorelbine
Vinorelbine (30 mg/m2) weekly IV injection
Other Name: Navelbine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male patients, >18 years of age, able to understand and give written informed consent.
  • Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. TNBC determination as per local institution as per standard guidelines.
  • Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC. Prior use of cisplatin (or carboplatin) is permitted.
  • Prior exposure to a taxane (paclitaxel or docetaxel)-based regimen in localized or advanced/metastatic setting.
  • 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 .
  • Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.
  • At least 2 weeks beyond prior treatment (chemotherapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy and/or radiation therapy) or major surgery, and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).
  • At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
  • 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 ≤ 2.0 x IULN, bilirubin ≤ 1.5 IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if known liver metastases).
  • Otherwise, all toxicity at study entry < Grade 1 by NCI CTCAE v4.00 (Patients with ≤ Grade 2 neuropathy are eligible).
  • Patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.

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 a mass over 7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.
  • Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • 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 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.
  • Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of study treatment.
  • Infection requiring intravenous antibiotic use within one week of enrollment.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02574455

Contacts
Contact: Heather Horne hhorne@immunomedics.com

Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Chair: William Wegener, MD,PhD Immunomedics, Inc.
  More Information

Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT02574455     History of Changes
Other Study ID Numbers: IMMU-132-05
Study First Received: October 8, 2015
Last Updated: March 27, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 26, 2017