A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
Purpose
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.
Condition
- Breast Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen. - Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent. - Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:. - Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC. - Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1. - Has a severe auto-immune disease or other contraindication. - Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments. - No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting). - Measurable disease by CT or MRI as per RECIST v1.1. - Other protocol-defined Inclusion/
Exclusion Criteria
apply.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A1 |
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|
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Experimental Arm A2 |
|
|
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Active Comparator Arm B |
|
Recruiting Locations
Helios Clinical Research
Cerritos 5335663, California 5332921 90703
Cerritos 5335663, California 5332921 90703
Contact:
Omkar Marathe, Site 0328
562-693-4477
Omkar Marathe, Site 0328
562-693-4477
USC/Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Contact:
Daphne Stewart, Site 0290
323-865-3906
Daphne Stewart, Site 0290
323-865-3906
Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067
Los Angeles 5368361, California 5332921 90067
Contact:
David Berz, Site 0283
424-535-1874
David Berz, Site 0283
424-535-1874
USC Norris Oncology/Hematology-Newport Beach
Newport Beach 5376890, California 5332921 92663
Newport Beach 5376890, California 5332921 92663
Contact:
Daphne Stewart, Site 0353
323-397-5954
Daphne Stewart, Site 0353
323-397-5954
Medical Oncology Hematology Consultants, PA
Newark 4143861, Delaware 4142224 19713
Newark 4143861, Delaware 4142224 19713
Contact:
Jamal Misleh, Site 0304
302-366-1200
Jamal Misleh, Site 0304
302-366-1200
Decatur Memorial Hospital
Decatur 4236895, Illinois 4896861 62526
Decatur 4236895, Illinois 4896861 62526
Contact:
James Wade, Site 0275
217-876-6611
James Wade, Site 0275
217-876-6611
Minnesota Oncology Hematology
Maple Grove 5036493, Minnesota 5037779 55369
Maple Grove 5036493, Minnesota 5037779 55369
Contact:
Eric Lander, Site 0313
Eric Lander, Site 0313
Clinical Research Alliance
Westbury 5144040, New York 5128638 11590
Westbury 5144040, New York 5128638 11590
Contact:
James D'Olimpio, Site 0295
646-872-8630
James D'Olimpio, Site 0295
646-872-8630
White Plains Hospital
White Plains 5144336, New York 5128638 10601
White Plains 5144336, New York 5128638 10601
Contact:
Dan Costin, Site 0285
914-849-7630
Dan Costin, Site 0285
914-849-7630
Willamette Valley Cancer Institute
Eugene 5725846, Oregon 5744337 97401
Eugene 5725846, Oregon 5744337 97401
Contact:
Miho Dougherty, Site 0316
Miho Dougherty, Site 0316
Texas Oncology - Northeast Texas
Flower Mound 4691585, Texas 4736286 75028
Flower Mound 4691585, Texas 4736286 75028
Contact:
Vibha Thomas, Site 0305
303-925-0700
Vibha Thomas, Site 0305
303-925-0700
(USOR) Texas Oncology
Houston 4699066, Texas 4736286 77024-2843
Houston 4699066, Texas 4736286 77024-2843
Contact:
Dhatri Kodali, Site 0314
555-555-5555
Dhatri Kodali, Site 0314
555-555-5555
Bon Secours St. Francis Medical Center
Midlothian 4772943, Virginia 6254928 23114
Midlothian 4772943, Virginia 6254928 23114
Contact:
William Irvin, Site 0277
William Irvin, Site 0277
Shenandoah Oncology, P.C.
Winchester 4794120, Virginia 6254928 22601
Winchester 4794120, Virginia 6254928 22601
Contact:
William Houck, Site 0302
540-662-1108
William Houck, Site 0302
540-662-1108
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Study Connect Contact Center www.BMSStudyConnect.com855-907-3286
Clinical.Trials@bms.com