A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 20, 2023

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2027

Conditions
Her 2 Positive Breast CancerBreast Cancer FemaleBreast Cancer Metastatic
Interventions
DRUG

Sacituzumab Govitecan

Trop-2-directed antibody-drug conjugate, 180 mg single-dose glass vial, via intravenous infusion per protocol.

DRUG

Trastuzumab

Humanized IgG1 kappa monoclonal antibody, 150mg single-dose vial, via intravenous infusion per protocol.

DRUG

Trastuzumab and Hyaluronidase-oysk

Recombinant monoclonal antibody, 6 mL vial, via subcutaneous injection per protocol.

Trial Locations (4)

33176

RECRUITING

Miami Cancer Institute at Baptist Health, Miami

37203

RECRUITING

SCRI Oncology Partners, Nashville

02215

RECRUITING

Dana Farber Cancer Institite, Boston

02190

RECRUITING

DFCI @ South Shore Hospital, South Weymouth

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Adrienne G. Waks

OTHER