Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast… (NCT03546686) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer
United States51 participantsStarted 2019-11-12
Plain-language summary
The purpose of this study is to determine the impact of pre-operative cryoablation, and immune checkpoint inhibition (ICI) on on 3-year Event Free Survival (EFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuvant chemotherapy.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Women age 18 years or older
✓. Confirmed histologic diagnosis of invasive carcinoma of the breast
✓. Pathology confirmation of invasive carcinoma (reported or requested and pending)
✓. ER, PR and HER2 negative on outside or Cedars Sinai biopsy report, where ER and PR negative are defined as staining present in ≤10% of invasive cancer cells by IHC, and HER2-negative is defined as IHC 0-1+ or FISH \<2.0. If ER, PR and HER2 status are not reported the results must be requested and pending.
✓. Operable tumor measuring ≥1.0 cm in maximal diameter
✓. Any nodal status allowed, including negative nodal status.
✓. Multifocal and multicentric disease is permitted if all foci have been biopsied and also meet the criteria for TNBC.
✓. Synchronous bilateral invasive breast cancer is permitted if all foci have been biopsied and also meet the criteria for TNBC.
Exclusion criteria
✕. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
✕. Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent or poorly controlled diarrhea.
What they're measuring
1
Event-Free Survival
Timeframe: 36 Months
Trial details
NCT IDNCT03546686
SponsorUniversity of Texas Southwestern Medical Center
✕. A history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer, or ovarian cancer.
✕. Has known active hepatitis B or hepatitis C.
✕. Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses). Brief periods of steroid use, for example for the management of chemotherapy-associated toxicities, are allowed. The use of corticosteroids on study is allowed for the treatment of immune related adverse events (irAEs) and other medical conditions including adrenal insufficiency.
✕. Any non-oncology live vaccine therapy used for prevention of infectious diseases within 3 weeks prior to first dose of ICI.
✕. Prior investigational agents within 3 weeks prior to ICI administration