NCT06100874

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Adrienne G. Waks · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: * Sacituzumab govitecan (a type of antibody-drug conjugate) * Trastuzumab (Herceptin) (a type of monoclonal antibody) * Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) * Trastuzumab biosimilar drug

Detailed description

This is an open-label, multi-center, single-arm phase II trial to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. Participants may receive a biosimilar drug to trastuzumab, which is a nearly identical "copycat" of an original drug that is manufactured by a different company The U.S. Food and Drug Administration (FDA) has not approved sacituzumab govitecan for Human-epidermal growth receptor 2-positive (HER2+) breast cancer, but it has been approved for triple negative breast cancer and hormone receptor positive but HER2-negative breast cancer. The U.S. FDA has approved Trastuzumab to be administered as an IV (intravenous) or subcutaneous (injection under the skin) for HER2+ breast cancer. The research study procedures include screening for eligibility, blood tests, Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans, biopsies, study treatment visits, echocardiograms and/or Multigated Acquisition (MUGA) scans. It is expected that about 40 people will take part in this research study. Gilead Sciences Inc. is supporting this research study by providing funding for the trial as well as one of the study drugs, sacituzumab govitecan.

Conditions

• Her 2 Positive Breast Cancer
• Breast Cancer Female
• Breast Cancer Metastatic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-20
• Primary completion: 2026-02-09
• Completion: 2027-11-30
• First posted: 2023-10-25
• Last updated: 2026-02-24

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study