AzTrials
AzTrials

Breast CancerPhase 3BRIA-ABCNCT06072612

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

A Phase 3 study testing SV-BR-1-GM, Cyclophosphamide and Interferon infiltration of the inoculation site in people with Breast Cancer and Metastatic Breast Cancer, run by BriaCell Therapeutics Corporation at 79 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SV-BR-1-GM, Cyclophosphamide and Interferon infiltration of the inoculation site
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
79 sitesUnited States
Study dates
5 Dec 2023to Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be ≥ 18 years of age.
  • Have signed informed consent.
  • Have histological confirmation of breast cancer with either locally recurrent unresectable and/or metastatic lesions, and have failed prior therapy:
  • Patients with persistent disease and local recurrence must not be amenable to local treatment.
  • For patients with metastatic disease, late-stage MBC with no meaningful alternative therapies available and the following class specific treatment histories:
  • Human epidermal growth factor 2 (HER2) positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen.
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  • Estrogen receptor (ER), progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy demonstrated by progression on at least 2 hormonal agents in 2 separate lines of hormone directed therapy.
  • Triple Negative tumors: Must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens, which can include regimens in neoadjuvant and adjuvant settings.
  • Cancers with known germline or genomic actionable targets, e.g. g/mBRCA, must have been treated with all tumor directed indicated treatment e.g. PARPi, if tolerated.
  • HER2 low patients, in addition to the appropriate therapies based on ER/PR status and germline or genomic actionable targets, must also have received at least one HER2-targeted agent approved for treatment of HER2 low patients.
  • HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens.
  • Patients with new or progressive breast cancer metastatic to the brain will be eligible provided:
  • The brain metastases must be clinically stable (without evidence of progressive disease by imaging for at least 4 weeks prior to first dose)
  • There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose
  • Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
  • If surgically debulked, must be healed with at least 3 weeks since surgery prior to the first dose
  • Has expected survival of at least 4 months.
  • ECOG performance status of 0, 1 or 2

Who cannot join

  • Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose.
  • Radiotherapy within 14 days of the first dose of study treatment.
  • Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support).
  • Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully treated (e.g. hypothyroidism or hypopituitarism treated with replacement therapy), .
  • Toxicity to prior CPI that has not resolved to grade 1 or less except for stable asymptomatic endocrinopathies.
  • History of clinical hypersensitivity to the designated therapy as specified in the protocol, including the proposed TPC, beef, or to any components used in the preparation of SV- BR-1-GM.
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  • History of hypersensitivity to any of the therapies proposed for treatment in this study.
  • Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) >2.0 × ULN or <30 mL/min for participants with creatinine levels >2.0 × institutional ULN.
  • Absolute granulocyte count <1000; platelets <80,000; hemoglobin ≤ 7 g/L.
  • Bilirubin ≥ 2 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >3x ULN. For patients with hepatic metastases, ALT/AST >5x ULN is exclusionary.
  • INR or PT or aPTT > 1.8 × ULN, unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
  • Receiving any medication listed in the prohibited medication section of the protocol.
  • Proteinuria >2+ on urinalysis
  • A history or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval >480 milliseconds is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is >480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is <480 milliseconds.
  • New York Heart Association stage 3 or 4 cardiac disease.
  • A pericardial effusion of moderate severity or worse.
  • Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
  • Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.
  • Men must have been sterile or, if they were potentially fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.
  • Women who are pregnant or nursing.
  • Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.
  • Patients who have uncontrolled HIV or have clinical or laboratory features indicative of AIDS.
  • Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Have an active autoimmune disease that has required systemic treatment in past year (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
  • Known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).
  • Active infections requiring systemic therapy within the past 14 days.
  • Patients with severe psychiatric disease (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator in consultation with the Medical Monitor.
  • Has received a live vaccine within 28 days of the first dose of study drug.
  • Patients may not be on a concurrent clinical trial, unless approved by the Investigator.

Trial locations and contacts

79 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Malobika Bhowmick contact

1-888-485-6340 ext. 2

mbhowmick@briacell.com

Marcela Salgado, MD contact

1-888-309-1868

MSalgado@briacell.com

79 sites in 1 country

United States79 sites, 79 recruiting

  • Los Angeles cancer Network_Anaheim

    Anaheim, California, 92801

    Amy Vuong, amy.vuong@lahomg.com

    Lasika Seneviratne, MD

    Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Madison Steininger, CCRC, 404-778-8145, madison.miller.stallings@emory.edu

    Keerthi Gogineni, MD

    Recruiting

  • University of Miami _SCCC - Aventura

    Aventura, Florida, 33180

    Yaima De La Fuente, 786-422-2551, Yaima.delaFuente@med.miami.edu

    Lawrence Negret, MD

    Recruiting

  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon)

    Babylon, New York, 11702

    Lauren Gianelli, 855-528-7322, lgianelli@nycancer.com

    Richard Zuniga, MD

    Recruiting

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

    Nicole Ward, 661-862-8548, nward@cbccusa.com

    Ravi Patel, MD

    Recruiting

  • The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A.

    Bethesda, Maryland, 20817

    Jenelle Larkin, CCRC, 301-571-0019 ext. 69355, Jenelle.Larkin@aoncology.com

    Natalie Bongiorno, RN, MSHS, 301-571-2016, Natalie.Bongiorno@aoncology.com

    Recruiting

  • Cedars-Sinai Cancer Beverly Hills

    Beverly Hills, California, 90211

    Amy Oppenheim, 310-423-3713, Amy.Oppenheim@cshs.org

    Yuan Yuan, MD

    Recruiting

  • Gabrail Cancer & Research Center

    Canton, Ohio, 44718

    Carrie Smith, RN, 330-492-3345, csmith@gabrailcancercenter.com

    Nashat Gabrail, MD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Nina Garcia, 312-695-1352, nina.garcia1@northwestern.edu

    Regina Stein, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Mariah Branem, CCRC, 866-320-4573, branemm@ccf.org

    Azka Ali, MD

    Recruiting

  • University of Miami-SCCC-Lennar

    Coral Gables, Florida, 33146

    Yisell Gongora, 305-270-3467, yxg780@med.miami.edu

    Irene Marino, 3052439221, idm32@med.miami.edu

    Recruiting

  • University of Miami_SCCC-Coral Springs

    Coral Springs, Florida, 33065

    Yaima De La Fuente, 786-422-2551, Yaima.delaFuente@med.miami.edu

    Lawrence Negret, MD

    Recruiting

  • Los Angeles Cancer Network_Corona

    Corona, California, 92879

    Elan Ingram, elan.ingram@lahomg.com

    Lasika Seneviratne, MD

    Recruiting

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

    Melissa Melendez-Salazar, RN, 214-370-1038, melissa.melende-salazar@usoncology.com

    Jessica Medina, CCRC, 214-370-1989, jessica.medina@usoncology.com

    Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas, 75251

    Akhil Valiyil, CCRC, 972-566-3061, avaliyil@marycrowley.org

    Angela Hotchkiss, 214-658-1958, ahotchkiss@marycrowley.org

    Recruiting

  • University of Miami Hospital and Clinics - Deerfield Beach

    Deerfield Beach, Florida, 33442

    Deborah Conte, CCRC, 954-210-1171, dmc238@med.miami.edu

    Lawrence M Negret, MD

    Recruiting

  • Northwest Cancer Center

    Dyer, Indiana, 46311

    Mariela Abad, 219-924-8178 ext. 279, mariela.abad@usoncology.com

    Shruti Singh, MD

    Recruiting

  • DHR Health Oncology Institute

    Edinburg, Texas, 78539

    Edgar Lopez, 956-362-2394, ed.lopez@dhr-rgv.com

    Vaney Capetillo, v.capetillo@dhr-rgv.com

    Recruiting

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

    Komel Sajjad, CCRC, 908-237-1201 ext. 262, ksajjad@hhsnj.org

    Myron E. Bednar, MD

    Recruiting

  • Los Angeles cancer Network_Fountain Vallley

    Fountain Valley, California, 92708

    Elan Ingram, elan.ingram@lahomg.com

    Lasika Seneviratne, MD

    Recruiting

  • Texas Oncology - Fredericksburg

    Fredericksburg, Texas, 78624

    Brenda Travieso, Brenda.Travieso@usoncology.com

    Emmalind Aponte, MD

    Recruiting

  • Hematology-Oncology Associates of Fredericksburg, Inc

    Fredericksburg, Virginia, 22408

    Ashley Lawrence, RN, OCN, 540-371-0079 ext. 149, alawrence@hoafredericksburg.com

    Amber Spurley, RN, 540-371-0079, research@hoafredericksburg.com

    Recruiting

  • Los Angeles Cancer Network_Glendale

    Glendale, California, 91206

    Amy Vuong, amy.vuong@lahomg.com

    Lasika Seneviratne, MD

    Recruiting

  • Texas Oncology - Harlingen

    Harlingen, Texas, 78550

    Nereida Salinas, nereida.salinas@usoncology.com

    Alvaro Restrepo, MD

    Recruiting

  • University of Miami_SCCC-Hollywood

    Hollywood, Florida, 33021

    Yaima De La Fuente, 786-422-2551, Yaima.delaFuente@med.miami.edu

    Lawrence Negret, MD

    Recruiting

  • Hoag Hospital Center

    Irvine, California, 92618

    Keeva Bromley, keeva.bromley@hoag.org

    Chaitali Nangia, MD

    Recruiting

  • Hoag Hospital Irvine

    Irvine, California, 92618

    Kevva Bromey, keeva.bromley@hoag.org

    Chaitali Nangia, MD

    Recruiting

  • Mayo Clinic Florida-Comprehensive Cancer Center

    Jacksonville, Florida, 32224

    Megan Skoglund, CCRC, 904-953-4350, Skoglund.Megan@mayo.edu

    Angelica Klosowski, 904-953-4529, Klosowski.Angelica@mayo.edu

    Recruiting

  • AMR Kansas City Oncology

    Kansas City, Kansas, 66204

    Jennifer Ross, CCRC, 913-386-7556, jennifer.ross@amrllc.com

    Jason Huntington, Site Manager, (913) 386-7556

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Rebecca Dabrowski, Rebecca.E.Dabrowski@Hitchcock.ORG

    Mary D. Chamberlin, MD

    Recruiting

  • Los Angeles Cancer Network

    Los Angeles, California, 90017

    Elizabeth Tica, 213-977-1214 ext. 3728, elizabeth.tica@lahomg.com

    Lasika C. Seneviratne, MD

    Recruiting

  • Cedars-Sinai Cancer at Cedars-Sinai Medical Facility

    Los Angeles, California, 90048

    Remona Delarea, 310-423-3713, Remona.Delarea@cshs.org

    Yuan Yuan, MD

    Recruiting

  • Los Angeles Cancer Network_Century City

    Los Angeles, California, 90067

    Amy Vuong, amy.vuong@lahomg.com

    Lasika Seneviratne, MD

    Recruiting

  • UCLA-Hematology/Oncology Medical Plaza

    Los Angeles, California, 90095

    Arika Fayton, 310-205-0771, AFayton@mednet.ucla.edu

    Kelly E McCann, MD, PhD

    Recruiting

  • UCLA-Hematology/Oncology_LA 2

    Los Angeles, California, 90095

    Rachelle Ancona, 310-205-0771, RAncona@mednet.ucla.edu

    Arika Fayton, AFayton@mednet.ucla.edu

    Recruiting

  • UCLA-Hematology/Oncology_LA

    Los Angeles, California, 90095

    Rachelle Ancona, 310-205-0771, RAncona@mednet.ucla.edu

    Kelly E. McCann, MD, PhD

    Recruiting

  • NYU Langone's Perlmutter Cancer Center

    Manhattan, New York, 10016

    Clevester Haynesworth, CCRC, 929-455-2451, Clevester.Haynesworth@nyulangone.org

    Nancy Chan, MD

    Recruiting

  • Care Access-Marrero

    Marrero, Louisiana, 70072

    William Robinson, RN, 351-227-7173, William.robinson@careaccess.com

    Shibu Varughese, MD

    Recruiting

  • Texas Oncology McAllen

    McAllen, Texas, 78503

    Nereida Salinas, RN, 956-687-5150, nereida.salinas@usoncology.com

    Alvaro Restrepo, MD

    Recruiting

  • University Of Miami-SCCC-Miami

    Miami, Florida, 33136

    Maynela Quinones, 305-243-2457, maynela@med.miami.edu

    Irene Marino, 305-243-9221, idm32@med.miami.edu

    Recruiting

  • University of Miami_SCCC - Kendall

    Miami, Florida, 33176

    Yaima De La Fuente, 786-422-2551, Yaima.delaFuente@med.miami.edu

    Lawrence Negret, MD

    Recruiting

  • Texas Oncology, New Braunfels

    New Braunfels, Texas, 78130

    Brenda Travieso, Brenda.Travieso@usoncology.com

    Emmalind Aponte, MD

    Recruiting

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06511

    Carl Brown, 475-241-1065, carl.brown@yale.edu

    Adriana Kahn, MD

    Recruiting

  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park)

    New Hyde Park, New York, 11042

    Lauren Gianelli, lgianelli@nycancer.com

    Richard Zuniga, MD

    Recruiting

  • Manhattan Hematology /Oncology Associates

    New York, New York, 10016

    Patricia Mccullough, RN, 212-689-6791, patriciarose13@gmail.com

    Alec Goldenberg, MD

    Recruiting

  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY)

    New York, New York, 10028

    Lauren Gianelli, lgianelli@nycancer.com

    Richard Zuniga, MD

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Heather Cordes, CCRC, 402-691-6970, hcordes@nebraskacancer.com

    Scott Degenhardt, 402-691-5257, sdegenhardt@nebraskacancer.com

    Recruiting

  • Advent Health - Orlando

    Orlando, Florida, 32804

    Ashley Young, CCRC, 407-303-2284, ashley.young@adventhealth.com

    Valeria BURKOVSKAYA, CCRC, 407-303-2283, valeria.burkovskaya@adventhealth.com

    Recruiting

  • Los Angeles Cancer Network_Pasadena

    Pasadena, California, 91105

    Elan Ingram, elan.ingram@lahomg.com

    Lasika Seneviratne, MD

    Recruiting

  • New York Cancers & Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Patchogue)

    Patchogue, New York, 11772

    Lauren Bilka, LPN, 631-675-5075, research@nycancer.com

    Richard Zuniga, MD

    Recruiting

  • Mayo Clinic-Comprehensive Cancer Center-Breast Clinic

    Phoenix, Arizona, 85054

    Alicia Ortiz, CCRC, 480-574-2802, ortiz.alicia@mayo.edu

    Brenda J. Ernst, MD

    Recruiting

  • University of Miami-SCCC-Plantation

    Plantation, Florida, 33324

    Deborah Conte, CCRC, 954-210-1171, dmc238@med.miami.edu

    Irene Marino, 3052439221, idm32@med.miami.edu

    Recruiting

  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Port Jefferson Station2)

    Port Jefferson Station, New York, 11776

    Lauren Gianelli, 855-528-7322, lgianelli@nycancer.com

    Richard Zuniga, MD

    Recruiting

  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1)

    Port Jefferson Station, New York, 11776

    Lauren Gianelli, 855-528-7322, lgianelli@nycancer.com

    Richard Zuniga, MD

    Recruiting

  • New York Cancers & Blood Specialists

    Port Jefferson Station, New York, 11776

    Lauren Gianelli, 855-528-7322, lgianelli@nycancer.com

    Laura Brady-Parisi, LPN, LPN, 631-675-5075, lbrady@nycancer.com

    Recruiting

  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead)

    Riverhead, New York, 11901

    Lauren Gianelli, lgianelli@nycancer.com

    Richard Zuniga, MD

    Recruiting

  • Los Angeles cancer Network_Riverside

    Riverside, California, 92501

    Elan Ingram, elan.ingram@lahomg.com

    Lasika Seneviratne, MD

    Recruiting

  • Mayo Clinic-Comprehensive Cancer Center-Breast Clinic

    Rochester, Minnesota, 55905

    Jennifer Hager, CCRC, 507-266-0539, Hager.Jennifer@mayo.edu

    Ciara O'Sullivan, M.B., B.Ch.

    Recruiting

  • Texas Oncology-San Antonio Cancer Care

    San Antonio, Texas, 78216

    Shannon Syring, RN, 210-419-2608, shannon.syring@usoncology.com

    Norma Norris, RN, 210-595-5613, norma.norris@usoncology.com

    Recruiting

  • Texas Oncology - San Antonio Northeast

    San Antonio, Texas, 78217

    Brenda Travieso, Brenda.Travieso@usoncology.com

    Emmalind Aponte, MD

    Recruiting

  • Texas Oncology - San Antonio Stone Oak

    San Antonio, Texas, 78258

    Brenda Travieso, Brenda.Travieso@usoncology.com

    Emmalind Aponte, MD

    Recruiting

  • UC San Diego

    San Diego, California, 92037

    Odelia Ha, 858-534-8248, oha@health.ucsd.edu

    Rebecca A. Shatsky, MD

    Recruiting

  • St. John's Cancer Center

    Santa Monica, California, 90404

    Pamela Torres, CCRC, pamela.torres@providence.org

    Parvin Peddi, MD

    Recruiting

  • UCLA-Department of Medicine Hematology/Oncology-Parkside

    Santa Monica, California, 90404

    Rachelle Ancona, 310-205-0771, RAncona@mednet.ucla.edu

    Kelly E. McCann, MD, PhD

    Recruiting

  • UCLA-Hetamtology/Oncology_S Monica

    Santa Monica, California, 90404

    Arika Fayton, 310-205-0771, AFayton@mednet.ucla.edu

    Kelly E. McCann, MD, PhD

    Recruiting

  • Sheboygan Cancer & Blood Specialists

    Sheboygan, Wisconsin, 53081

    Maria Splittgerber, 920-452-1650 ext. 318, msplittgerber@physhealthnet.com

    S. Mark Bettag, MD

    Recruiting

  • Cancer Care Northwest-1 (601 S. Sherman)

    Spokane, Washington, 99202

    Ronaye Wagner, Ronaye.wagner@ccnw.net

    Kristine Rinn, MD

    Recruiting

  • Cancer Care Northwest_2 (605 E. Holland)

    Spokane, Washington, 99218

    Ronaye Wagner, Ronaye.wagner@ccnw.net

    Kristine Rinn, MD

    Recruiting

  • Cancer Care Northwest

    Spokane Valley, Washington, 99218

    Ronaye Wagner, RN, MSN, 509-228-1680, Ronaye.wagner@ccnw.net

    Bethany Giachetti, BS, CCRC, 509-228-1684, Bethany.giachetti@ccnw.net

    Recruiting

  • Southern Illinois University-Simmons

    Springfield, Illinois, 62702

    Kathy Robinson, 217-545-1946, krobinson@siumed.edu

    Krishna Rao, MD

    Recruiting

  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Brox)

    The Bronx, New York, 10469

    Lauren Gianelli, 855-528-7322, lgianelli@nycancer.com

    Richard Zuniga, MD

    Recruiting

  • Torrance Memorial Cancer Center

    Torrance, California, 90505

    Jessica Yoshinaga, 310-750-3378, jyoshinaga@mednet.ucla.edu

    Crystal Taylor, ctaylor@trio-us.org

    Recruiting

  • University of Arizona-Cancer Center

    Tucson, Arizona, 85719

    Stanna Calderon, SC, 520-621-5901, stannacalderon@arizona.edu

    Sima Ehsani, MD

    Recruiting

  • Carle Foundation Cancer Institute-Urbana

    Urbana, Illinois, 61801

    Christine Rogers, 217-383-3394, christine.rogers@carle.com

    Kendrith Rowland, MD

    Recruiting

  • Los Angeles Cancer Network_Valley Pres

    Van Nuys, California, 91405

    Elan Ingram, elan.ingram@lahomg.com

    Lasika Seneviratne, MD

    Recruiting

  • Tranquil Clinical Research

    Webster, Texas, 77598

    Veronica D. Mohammed, RN, 713-907-6054, veronicam@tranquilityresearch.com

    Patricia Roark, RN, 346-435-9438, patriciar@tranquilityresearch.com

    Recruiting

  • Texas Oncology - Weslaco

    Weslaco, Texas, 78596

    Nereida Salinas, RN, nereida.salinas@usoncology.com

    Alvaro Restrepo, MD

    Recruiting

  • Cedars-Sinai Breast Health Services Building

    West Hollywood, California, 90048

    Remona Delarea, 310-423-3713, Remona.Delarea@cshs.org

    Yuan Yuan, MD

    Recruiting

  • Regional Medical Oncology Center_Wlson

    Wilson, North Carolina, 27893

    Taylor Bryant, RN, 252-991-5261, taylor.bryant@regionaloncology.com

    Keith Lerro, MD

    Recruiting

Other trials in United States

About this study

Official title: Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

Read the detailed description

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available. A secondary objective will be to evaluate the activity of the Bria-IMT regimen alone in comparison with the Bria-IMT regimen in combination with CPI.

Initial randomization will be 1:1:1 to the Bria-IMT regimen + CPI (combination therapy), TPC, and the Bria-IMT regimen alone (monotherapy). After the first 150 patients have enrolled in the study, the monotherapy arm will be discontinued and patients allowed to cross over to the combination therapy if needed. Randomization will continue 1:1 between the combination therapy vs TPC.

For the Bria regimen +/- CPI arms, treatment cycles occur every 3 weeks. TPC cycle details will be according to the site's SOC. In the absence of progressive disease or major safety issues, the patient will continue with therapy cycles, with imaging assessment every 6 weeks x2 then every 8 weeks thereafter.

The Bria-IMT regimen includes:

Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon intra-dermally within each Bria-IMT inoculation site

Being tested
SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Keywords
Breast, metastatic, advanced, cancer, late line
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SV-BR-1-GMBiological

    Also called Part of the Bria-IMT regimen

    SV-BR-1-GM is an experimental, allogeneic, whole cell breast tumor cell line stably transfected with the CSF2 gene (encoding GM-CSF) to secrete GM-CSF in vivo to consequently augment dendritic cell activity

  • CyclophosphamideDrug

    Cyclophosphamide is an alkylating agent with indications for treatment of malignant diseases including breast cancer. Cyclophosphamide (Cytoxan) 300 mg/m2 I.V., single dose, will be given to patients assigned to the SV-BR-1-GM. Cyclophosphamide will be administered 2-3 days prior to SV-BR-1-GM inoculations.

  • Interferon infiltration of the inoculation siteDrug

    Interferon is a cytokine released by cells to regulate immune responses to viral infections. For this study, 0.1 mcg Pegasys per injection site (x 4 injection sites) will be administered.

  • RetifanlimabDrug

    Retifanlimab is a checkpoint inhibitor. A total dose of 375mg will be administered at first cycle on or about day +2 (+/-1d). In all other cycles, Retifanlimab is permitted to be administered between Day -2/-3 to Day 2±1 of the cycle based on the convenience of the patients and the clinical sites. However once the timing of the CPI is chosen for C1, it must be given on the same day thereafter throughout the trial.

  • Treatment of Physician's ChoiceDrug

    Patients in the TPC arm of the study will be treated with one or a combination of the following: carboplatin, taxanes, capecitabine, gemcitabine, vinorelbine or eribulin in accordance with the investigators and institutional standard of care. For HER2+ patients, a HER2-targeted agent of the physician's choice can be part of TPC.

Study groups in NCT06072612
Study groupRoleWhat they receive
Bria-IMT Regimen + CPIExperimentalThe Bria-IMT regimen: Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon administered intra-dermally within each SV-BR-1-GM inoculation site
Receives: Biological: SV-BR-1-GM; Drug: Cyclophosphamide; Drug: Interferon infiltration of the inoculation site; Drug: Retifanlimab
Treatment of Physician's ChoiceActive comparatorTPC consists of eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine or taxanes in accordance with the investigators' and institutional standard of care. The specific details of the selected regimen must include every detail of administration including frequency, sequencing (for multi-agent regimens), duration of infusion or oral administration, planned dose, dose prescribed, dose administered, dose adjustments after initial prescription or start of TPC treatment, and any other change in TPC from its initial election prior to randomization.
Receives: Drug: Treatment of Physician's Choice
Bria-IMT Regimen AloneExperimentalThe Bria-IMT regimen: Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon administered intra-dermally within each SV-BR-1-GM inoculation site
Receives: Biological: SV-BR-1-GM; Drug: Cyclophosphamide; Drug: Interferon infiltration of the inoculation site

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    To evaluate the effect of the Bria-IMT regimen in combination with Check Point Inhibitor (CPI) on overall survival (OS) compared to treatment of physician's choice (TPC) chemotherapy in patients with metastatic breast cancer with no approved alternative therapies available as per the Inclusion criteria.

    Measured: Up to 60 months

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    To evaluate the effect of the Bria-IMT regimen with CPI on progression-free survival (PFS)

    • To assess the single agent activity of the Bria-IMT regimen in the sample cohort using PFS, ORR, and CBR

    Measured: Up to 60 months

  2. Clinical Benefit Rate (CBR)

    To evaluate the efficacy of the Bria-IMT regimen with CPI using Clinical Benefit Rate (CBR)

    Measured: Up to 60 months

  3. Overall response rate (ORR)

    To evaluate the efficacy of the Bria-IMT regimen with CPI using best overall response rate (ORR)

    Measured: Up to 60 months

  4. Quality of life (QoL)

    To compare the effect of the Bria-IMT regimen with CPI on quality of life (QoL) including time without symptoms and time without toxicities (TWiST) adjusted for time on study.

    Measured: Up to 60 months

  5. CNS Event free survival (EFS)

    CNS event free survival for subjects with and without known CNS metastases at baseline

    Measured: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start5 Dec 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
404 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06072612
Sponsor's protocol ID
BC-IMT-04
Acronym
BRIA-ABC
Status last verified
Sep 2026
First submitted
25 Sep 2023
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SV-BR-1-GM, Cyclophosphamide and Interferon infiltration of the inoculation site in people with Breast Cancer and Metastatic Breast Cancer, run by BriaCell Therapeutics Corporation at 79 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Malobika Bhowmick (1-888-485-6340 ext. 2, mbhowmick@briacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06072612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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