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

NCT06100874 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-531
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

Brief 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

Breast Cancer Female; Breast Cancer Metastatic; Her 2 Positive Breast Cancer

Keywords

HER2 + Breast Cancer; HER 2 Positive Breast Cancer; Breast Cancer Female; Breast Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria.

  3 years

Secondary Outcomes (5)

• Median Progression-Free Survival (PFS)

  3 years

• Median Overall Survival (OS)

  10 years

• Clinical Benefit Rate (CBR)

  3 years

• Median Duration of Overall Response (DOR)

  3 years

• Grade 3-5 Treatment-related Toxicity Rate

  3 years

Study Arms (1)

Sacituzumab Govitecan + Trastuzumab (or Biosimilar)

EXPERIMENTAL

Participants will complete the following: * Baseline visit with assessments. * CT or MRI scans every 9 weeks for 27 weeks and then every 12 weeks. * Echocardiogram or MUGA scan every 12 weeks for 24 weeks and then every 16 weeks. * Cycle 1 through Cycle 2: * Days 1 and 8 of 21 day cycle: Predetermined dose of Sacituzumab govitecan 1x daily. * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab either intravenously or subcutaneously 1x daily. * Cycle 2: * Day 1: Optional tumor biopsy * Days 1 and 8 of 21 day cycle: Predetermined dose of Sacituzumab govitecan 1x daily. * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab either intravenously or subcutaneously 1x daily. * Cycle 3 through End of Treatment: * Days 1 and 8 of 21 day cycle: Predetermined dose of Sacituzumab govitecan 1x daily. * Day 1 of 21 day cycle: Predetermined dose of Trastuzumab either intravenously or subcutaneously 1x daily. * End of treatment: * Follow up visits every 6 months.

Drug: Sacituzumab Govitecan; Drug: Trastuzumab; Drug: Trastuzumab and Hyaluronidase-oysk

Interventions

Sacituzumab Govitecan DRUG

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

Also known as: Trodelvy

Sacituzumab Govitecan + Trastuzumab (or Biosimilar)

Trastuzumab DRUG

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

Also known as: Herceptin

Sacituzumab Govitecan + Trastuzumab (or Biosimilar)

Trastuzumab and Hyaluronidase-oysk DRUG

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

Also known as: Herceptin Hylecta

Sacituzumab Govitecan + Trastuzumab (or Biosimilar)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically or cytologically confirmed invasive breast cancer, with unresectable locally advanced or metastatic disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.
• At least one measurable lesion that can be accurately assessed at baseline by CT (MRI where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.149 (see Section 11).
• NOTE: If the only site of measurable of disease has been previously irradiated, there must be evidence of post-radiation progression.
• Either the primary tumor or the metastasis (or both) must be HER2+ per ASCO/CAP 2018 guidelines.1 Central confirmation of HER2 status is not required.
• Any ER and PR expression are permitted but must be known.
• Participants must have received prior treatment with a taxane, trastuzumab, and T-DXd. These agents may have been administered in the curative or the advanced setting. Prior progression on these agents is not required. T-DXd does not need to be the most recent prior therapy.
• Participants must have discontinued all chemotherapy, biologic treatment or investigational agent at least 14 days prior to study treatment initiation (any prior endocrine therapy does not require washout).
• All toxicities related to prior chemotherapy must have resolved to CTCAE v5.0 grade 1 or lower, except alopecia can be any grade and neuropathy can be grade 2 or lower.
• Participants on bisphosphonates or RANK ligand inhibitors may continue receiving therapy during study treatment and also may initiate therapy with these agents on study if clinically indicated.
• Prior radiation therapy must be completed at least 7 days prior to study treatment initiation, and all toxicities related to prior radiation therapy must have resolved to CTCAE v5.0 grade 1 or lower, unless otherwise specified in 3.1.14.
• Previously treated brain metastases are permitted, with the following provisions: (1) Prior SRS should be completed ≥ 7 days before study treatment initiation; (2) Prior WBRT should be completed ≥ 7 days before study treatment initiation. (3) Any corticosteroid use for brain metastases must have been discontinued for ≥ 7 days prior to study treatment initiation.
• Pre- and postmenopausal women or male patients ≥ 18 years old.
• ECOG performance status of 0 - 2 (Karnofsky \> 50%).
• Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
• Participants must have normal organ and bone marrow function as defined below:

You may not qualify if:

• Prior therapy with any Trop-2 directed ADC, including sacituzumab govitecan.
• Prior hypersensitivity to trastuzumab, sacituzumab govitecan, or the excipients of trastuzumab or sacituzumab govitecan.
• Known history of UDP-glucuronosyltransferase 1A1 (UGT1A1) \*28 allele homozygosity, which is associated with increased risk for neutropenia and diarrhea related to irinotecan.50 UGT1A1 genotyping is not required for eligibility.
• Note: Concurrent administration of strong UGT1A1 inhibitors or inducers is not allowed during the study (See Section 5.5).
• Known brain metastases that are untreated, symptomatic, or require corticosteroid therapy to control symptoms.
• Known leptomeningeal disease.
• Major surgery within 2 weeks prior to study treatment initiation. Patients must have recovered from any effects of any recent major surgery.
• Individuals with a history of a second malignancy are ineligible except for the following circumstances:
• Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy.
• Individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin.
• Patients with other cancers diagnosed within the past 3 years and felt to be at low
• risk of recurrence should be discussed with the study principal investigator to determine eligibility.
• Uncontrolled, significant intercurrent or recent illness including, but not limited to, ongoing or active infection, uncontrolled non-malignant systemic disease, uncontrolled seizures, or psychiatric illness/social situation that would limit compliance with study requirements in the opinion of the treating investigator.
• Participants who are pregnant or breast-feeding are not eligible for enrollment.

Sponsors & Collaborators

• Adrienne G. Waks: lead
• Gilead Sciences: collaborator

Study Sites (4)

Miami Cancer Institute at Baptist Health

Miami, Florida, 33176, United States

Location

Dana Farber Cancer Institite

Boston, Massachusetts, 02215, United States

Location

DFCI @ South Shore Hospital

South Weymouth, Massachusetts, 02190, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sacituzumab govitecan; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Adrienne Waks, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: November 20, 2023
• Primary Completion: February 9, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (4)