Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)

Part of paid clinical trials in San Francisco, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04434040
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab is a type of antibody and is administered intravenously.
  • Sacituzumab govitecan — DRUG
    Sacituzumab govitecan is an antibody drug conjugate and is administered intravenously

Study Details

The purpose of this study is to determine if a combination of two drugs sacituzumab govitecan and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood. This research study involves the following investigational drugs: * Sacituzumab govitecan * Atezolizumab

Key Dates

Start date
Jul 2, 2020
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab and Sacituzumab govitecan
    Patients will receive the following treatment: Atezolizumab and Sacituzumab govitecan treatment will continue for 6 cycles (18 total weeks). * Atezolizumab intravenously (IV) at a pre-determined dose on day 1 in a 21-day cycle * Sacituzumab govitecan: intravenously (IV) at a pre-determined dose on days 1 and 8 in a 21-day cycle

Primary Outcome Measure

Rate of undetectable circulating tumor cfDNA- 6 Cycles [ Time Frame: 18 Weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94115
Jo Chien, MD
[email protected]
Jo Chien, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois60637-
University of Chicago Comprehensive Cancer Center at Silver Cross HospitalNew LenoxIllinois60451-
University of Chicago Medical Center for Advanced Care Orland ParkOrland ParkIllinois60462-
Dana-Farber Cancer InstituteBostonMassachusetts02215
Elizabeth A Mittendorf, MD, PhD
[email protected]
617-582-9980
Elizabeth A Mittendorf, MD, PHD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania-Abramson Cancer CenterPhiladelphiaPennsylvania19104
Angela DeMichele, MD
[email protected]
215-349-5319
Angela DeMichele, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232
Vandana Abramson, MD
[email protected]
Vandana Abramson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of California San Francisco· San Francisco, CAUniversity of Chicago Medical Center· Chicago, ILUniversity of Chicago Comprehensive Cancer Center at Silver Cross Hospital· New Lenox, ILUniversity of Chicago Medical Center for Advanced Care Orland Park· Orland Park, ILDana-Farber Cancer Institute· Boston, MAUniversity of Pennsylvania-Abramson Cancer Center· Philadelphia, PA

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