Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03546686
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembro will be administered 1-20 days before the cryoablation date per SOC and q3 weeks after surgery for 9 cycles per SOC.
  • Core Biopsy/Cryoablation — PROCEDURE
    US-guided core biopsy and cryoablation 7-10 days prior to surgery.
  • Breast Surgery — PROCEDURE
    Standard-of-care definitive surgery.
  • Ipilimumab — DRUG
    ipilimumab 1mg/Kg IV is administered 1-5 days prior to cryoablation.
  • Nivolumab — DRUG
    nivolumab 240mg IV flat dose is administered 1-5 days prior to cryoablation and 240mg IV every 2 weeks ± 3 days starting 3 (+/-1) weeks after surgery.

Study Details

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.

Key Dates

Start date
Nov 12, 2019
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Pembrolizumab + Core Biopsy/Cryoablation + Breast Surgery +Post Surgery pembrolizumab OR Ipilimumab and Nivolumab + Core Biopsy/Cryoablation + Breast Surgery +Post Surgery Nivolumab

Primary Outcome Measure

Event-Free Survival [ Time Frame: 36 Months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Ohio State University Medical CenterColumbusOhio43210-
Providence Cancer InstitutePortlandOregon97213-
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cedars Sinai Medical Center· Los Angeles, CAOhio State University Medical Center· Columbus, OHProvidence Cancer Institute· Portland, ORUT Southwestern Medical Center· Dallas, TX

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