OncoMatch/Clinical Trials/NCT06072612
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
Is NCT06072612 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast cancer.
Treatment: SV-BR-1-GM · Cyclophosphamide · Interferon infiltration of the inoculation site · Retifanlimab · Treatment of Physician's Choice — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) positive
HER2 positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen
Required: ESR1 positive
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
Required: PR (PGR) positive
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
Required: HER2 (ERBB2) low (HER2-low)
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
Required: HER2 (ERBB2) negative (HER2-negative)
HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens
Required: ESR1 negative (ER-negative)
Triple Negative tumors: Must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens
Required: PR (PGR) negative (PR-negative)
Triple Negative tumors: Must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens
Allowed: BRCA1 germline or genomic actionable mutation
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
Allowed: BRCA2 germline or genomic actionable mutation
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
Disease stage
Metastatic disease required
locally recurrent unresectable and/or metastatic lesions
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-HER2 therapy — HER2-positive
HER2 positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen
Must have received: chemotherapy — HER2-positive
HER2 positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen
Must have received: hormonal therapy — Hormone Receptor-Positive
ER, 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
Must have received: chemotherapy — Triple Negative
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
Must have received: PARP inhibitor — germline or genomic actionable targets (e.g. g/mBRCA)
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
Must have received: anti-HER2 therapy — HER2-low
HER2 low patients...must also have received at least one HER2-targeted agent approved for treatment of HER2 low patients
Must have received: hormonal therapy — HER2-negative (if indicated)
HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens
Must have received: chemotherapy — HER2-negative
HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens
Lab requirements
Blood counts
Absolute granulocyte count <1000; platelets <80,000; hemoglobin ≤ 7 g/L.
Kidney function
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.
Liver function
Bilirubin ≥ 2 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase >5x ULN; ALT/AST >3x ULN. For patients with hepatic metastases, ALT/AST >5x ULN is exclusionary.
Cardiac function
A history or presence of an abnormal 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.
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 ULN; ALT/AST >3x ULN. For patients with hepatic metastases, ALT/AST >5x ULN is exclusionary. A history or presence of an abnormal 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic-Comprehensive Cancer Center-Breast Clinic · Phoenix, Arizona
- University of Arizona-Cancer Center · Tucson, Arizona
- Los Angeles cancer Network_Anaheim · Anaheim, California
- Comprehensive Blood and Cancer Center · Bakersfield, California
- Cedars-Sinai Cancer Beverly Hills · Beverly Hills, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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