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Compares treatment options for Breast Cancer
Official title Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
ClinicalTrials.gov ID: NCT06072612
What this study is testing
What is SV-BR-1-GM?
SV-BR-1-GM is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as Part of the Bria-IMT regimen.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully treated (e.g. hypothyroidism or hypopituitarism treated with...
- 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...
See the full eligibility criteria
Who can 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.
- 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...
- 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
What rules you out
- 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.
- 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 \ 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Anaheim, California, United States
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Corona, California, United States
- Fountain Valley, California, United States
- Glendale, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Pasadena, California, United States
- Riverside, California, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Torrance, California, United States
- Van Nuys, California, United States
- West Hollywood, California, United States
- New Haven, Connecticut, United States
- Aventura, Florida, United States
- Coral Gables, Florida, United States
+ 43 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Anaheim, California, United States; Bakersfield, California, United States; Beverly Hills, California, United States; Corona, California, United States and 57 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.