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

NCT06100874 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-02-24

No results posted yet for this study

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

Conditions

  • Her 2 Positive Breast Cancer
  • Breast Cancer Female
  • Breast 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.

Sponsors & Collaborators

Principal Investigators

  • Adrienne Waks, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2026-02-09
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06100874 on ClinicalTrials.gov