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New hope for late-stage breast cancer patients with no other options

NCT ID NCT06072612

Disease control Sponsor: BriaCell Therapeutics Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This study tests whether a new treatment called Bria-IMT, given with an immunotherapy drug, helps people with advanced metastatic breast cancer live longer compared to standard chemotherapy. About 404 adults whose cancer has not responded to other treatments will participate. The goal is to see if this combination improves survival and slows cancer growth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 404 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Be ≥ 18 years of age. 2. Have signed informed consent. 3. 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: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens. 7. 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 4. Has expected survival of at least 4 months. 5. ECOG performance status of 0, 1 or 2 Exclusion Criteria: 1. Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose. 2. Radiotherapy within 14 days of the first dose of study treatment. 3. 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). 4. 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), . 5. Toxicity to prior CPI that has not resolved to grade 1 or less except for stable asymptomatic endocrinopathies. 6. 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. 7. History of hypersensitivity to any of the therapies proposed for treatment in this study. 8. 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. 9. Absolute granulocyte count \<1000; platelets \<80,000; hemoglobin ≤ 7 g/L. 10. 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. 11. 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. 12. Receiving any medication listed in the prohibited medication section of the protocol. 13. Proteinuria \>2+ on urinalysis 14. 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. 15. New York Heart Association stage 3 or 4 cardiac disease. 16. A pericardial effusion of moderate severity or worse. 17. Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible. 18. 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. 19. 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. 20. Women who are pregnant or nursing. 21. 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. 22. Patients who have uncontrolled HIV or have clinical or laboratory features indicative of AIDS. 23. 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. 24. 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. 25. 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). 26. Active infections requiring systemic therapy within the past 14 days. 27. 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. 28. Has received a live vaccine within 28 days of the first dose of study drug. 29. Patients may not be on a concurrent clinical trial, unless approved by the Investigator.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Breast cancer metastatic Breast neoplasm End stage cancer Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    79 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AMR Kansas City Oncology

    RECRUITING

    Kansas City, Kansas, 66204, United States

  • Advent Health - Orlando

    RECRUITING

    Orlando, Florida, 32804, United States

  • Cancer Care Northwest

    RECRUITING

    Spokane Valley, Washington, 99218, United States

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

    RECRUITING

    Spokane, Washington, 99202, United States

  • Cancer Care Northwest_2 (605 E. Holland)

    RECRUITING

    Spokane, Washington, 99218, United States

  • Care Access-Marrero

    RECRUITING

    Marrero, Louisiana, 70072, United States

  • Carle Foundation Cancer Institute-Urbana

    RECRUITING

    Urbana, Illinois, 61801, United States

  • Cedars-Sinai Breast Health Services Building

    RECRUITING

    West Hollywood, California, 90048, United States

  • Cedars-Sinai Cancer Beverly Hills

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Cedars-Sinai Cancer at Cedars-Sinai Medical Facility

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Comprehensive Blood and Cancer Center

    RECRUITING

    Bakersfield, California, 93309, United States

  • DHR Health Oncology Institute

    RECRUITING

    Edinburg, Texas, 78539, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Gabrail Cancer & Research Center

    RECRUITING

    Canton, Ohio, 44718, United States

  • Hematology-Oncology Associates of Fredericksburg, Inc

    RECRUITING

    Fredericksburg, Virginia, 22408, United States

    Contact Email: •••••@•••••

  • Hoag Hospital Center

    RECRUITING

    Irvine, California, 92618, United States

  • Hoag Hospital Irvine

    RECRUITING

    Irvine, California, 92618, United States

  • Hunterdon Medical Center

    RECRUITING

    Flemington, New Jersey, 08822, United States

  • Los Angeles Cancer Network

    RECRUITING

    Los Angeles, California, 90017, United States

  • Los Angeles Cancer Network_Century City

    RECRUITING

    Los Angeles, California, 90067, United States

  • Los Angeles Cancer Network_Corona

    RECRUITING

    Corona, California, 92879, United States

  • Los Angeles Cancer Network_Glendale

    RECRUITING

    Glendale, California, 91206, United States

  • Los Angeles Cancer Network_Pasadena

    RECRUITING

    Pasadena, California, 91105, United States

  • Los Angeles Cancer Network_Valley Pres

    RECRUITING

    Van Nuys, California, 91405, United States

  • Los Angeles cancer Network_Anaheim

    RECRUITING

    Anaheim, California, 92801, United States

  • Los Angeles cancer Network_Fountain Vallley

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Los Angeles cancer Network_Riverside

    RECRUITING

    Riverside, California, 92501, United States

  • Manhattan Hematology /Oncology Associates

    RECRUITING

    New York, New York, 10016, United States

  • Mary Crowley Cancer Research

    RECRUITING

    Dallas, Texas, 75251, United States

  • Mayo Clinic Florida-Comprehensive Cancer Center

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic-Comprehensive Cancer Center-Breast Clinic

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic-Comprehensive Cancer Center-Breast Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • NYU Langone's Perlmutter Cancer Center

    RECRUITING

    Manhattan, New York, 10016, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

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

    RECRUITING

    The Bronx, New York, 10469, United States

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

    RECRUITING

    New York, New York, 10028, United States

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

    RECRUITING

    Babylon, New York, 11702, United States

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

    RECRUITING

    Port Jefferson Station, New York, 11776, United States

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

    RECRUITING

    Riverhead, New York, 11901, United States

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

    RECRUITING

    New Hyde Park, New York, 11042, United States

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

    RECRUITING

    Port Jefferson Station, New York, 11776, United States

  • New York Cancers & Blood Specialists

    RECRUITING

    Port Jefferson Station, New York, 11776, United States

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

    RECRUITING

    Patchogue, New York, 11772, United States

    Contact Email: •••••@•••••

  • Northwest Cancer Center

    RECRUITING

    Dyer, Indiana, 46311, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Regional Medical Oncology Center_Wlson

    RECRUITING

    Wilson, North Carolina, 27893, United States

  • Sheboygan Cancer & Blood Specialists

    RECRUITING

    Sheboygan, Wisconsin, 53081, United States

  • Smilow Cancer Hospital at Yale New Haven

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Southern Illinois University-Simmons

    RECRUITING

    Springfield, Illinois, 62702, United States

  • St. John's Cancer Center

    RECRUITING

    Santa Monica, California, 90404, United States

  • Texas Oncology - Fredericksburg

    RECRUITING

    Fredericksburg, Texas, 78624, United States

  • Texas Oncology - Harlingen

    RECRUITING

    Harlingen, Texas, 78550, United States

  • Texas Oncology - San Antonio Northeast

    RECRUITING

    San Antonio, Texas, 78217, United States

  • Texas Oncology - San Antonio Stone Oak

    RECRUITING

    San Antonio, Texas, 78258, United States

  • Texas Oncology - Weslaco

    RECRUITING

    Weslaco, Texas, 78596, United States

  • Texas Oncology McAllen

    RECRUITING

    McAllen, Texas, 78503, United States

  • Texas Oncology, New Braunfels

    RECRUITING

    New Braunfels, Texas, 78130, United States

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Texas Oncology-San Antonio Cancer Care

    RECRUITING

    San Antonio, Texas, 78216, United States

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

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Torrance Memorial Cancer Center

    RECRUITING

    Torrance, California, 90505, United States

  • Tranquil Clinical Research

    RECRUITING

    Webster, Texas, 77598, United States

  • UC San Diego

    RECRUITING

    San Diego, California, 92037, United States

  • UCLA-Department of Medicine Hematology/Oncology-Parkside

    RECRUITING

    Santa Monica, California, 90404, United States

  • UCLA-Hematology/Oncology Medical Plaza

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCLA-Hematology/Oncology_LA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCLA-Hematology/Oncology_LA 2

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCLA-Hetamtology/Oncology_S Monica

    RECRUITING

    Santa Monica, California, 90404, United States

  • University Of Miami-SCCC-Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Arizona-Cancer Center

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Miami Hospital and Clinics - Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • University of Miami _SCCC - Aventura

    RECRUITING

    Aventura, Florida, 33180, United States

  • University of Miami-SCCC-Lennar

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • University of Miami-SCCC-Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • University of Miami_SCCC - Kendall

    RECRUITING

    Miami, Florida, 33176, United States

  • University of Miami_SCCC-Coral Springs

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • University of Miami_SCCC-Hollywood

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

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