Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Ana C Garrido-Castro, MD
Study ID
NCT04448886
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    (iv) fixed dose, administered once per cycle
  • Sacituzumab Govitecan — DRUG
    (iv) fixed dose, administered twice per cycle

Study Details

This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer. The names of the study interventions involved in this study are: * Sacituzumab govitecan (IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)

Key Dates

Start date
Sep 23, 2020
Status verified
Dec 2025
Primary completion
Mar 9, 2024
Completion
Jun 1, 2027

Study Design

Enrollment
110 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab Govitecan + Pembrolizumab
    The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days * Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle * Pembrolizumab (iv) fixed dose administered once per cycle
  • Experimental: Sacituzumab Govitecan
    The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. \- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle
  • Experimental: Retreatment
    Participants who have attained a confirmed complete response (CR) who have been treated for at least 24 weeks on protocol therapy and had at least three cycles (with pembrolizumab and sacituzumab govitecan (Arm A) or sacituzumab govitecan alone (Arm B)) beyond the date when the initial CR was declared may be eligible for additional sacituzumab govitecan and/or pembrolizumab therapy if they progress after stopping study treatment. This retreatment is termed the Second Course Phase of this study and is only available if the study remains open and the subject meets protocol-specified conditions.

Primary Outcome Measure

Progression Free Survival [ Time Frame: Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration to primary analysis of PFS is 38 months. The reported data is as of data cutoff of 3/9/2024. ]

Locations (8)

FacilityCityStateZIPSite coordinators
Emory University/Winship Cancer InstituteAtlantaGeorgia30322-
University of Chicago Medical CenterChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02215-
DFCI @ FoxboroughFoxboroughMassachusetts02035-
DFCI @ Milford Regional HospitalMilfordMassachusetts01757-
DF/BWCC in Clinical Affiliation with South Shore HospitalSouth WeymouthMassachusetts02190-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
University of Pennsylvania-Abramson Cancer CenterPhiladelphiaPennsylvania19104-

Related coverage on Hipa.ai

Find similar trials in Atlanta, GA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Emory University/Winship Cancer Institute· Atlanta, GAUniversity of Chicago Medical Center· Chicago, ILDana Farber Cancer Institute· Boston, MADFCI @ Foxborough· Foxborough, MADFCI @ Milford Regional Hospital· Milford, MADF/BWCC in Clinical Affiliation with South Shore Hospital· South Weymouth, MA

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