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ACTIVE NOT RECRUITING Phase 2

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

NCT06100874 · View on ClinicalTrials.gov ↗

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

Interventions

  • DRUG Trastuzumab
  • DRUG Sacituzumab Govitecan
  • DRUG Trastuzumab and Hyaluronidase-oysk

Study Locations (4)

Massachusetts

  • Dana Farber Cancer Institite — Boston
  • DFCI @ South Shore Hospital — South Weymouth

Florida

  • Miami Cancer Institute at Baptist Health — Miami

Tennessee

  • SCRI Oncology Partners — Nashville

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2023-11-20
Est. Completion 2027-11-30
Phase Phase 2

Sponsor

Adrienne G. Waks

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06100874

The ClinicalTrials.gov registry entry for NCT06100874 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adrienne G. Waks, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Breast Cancer Female appearing as the primary indexed condition, and to 3 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06100874 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Massachusetts, Florida, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06100874 about?

NCT06100874 is a clinical study titled "A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)". 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...

What is the current status of trial NCT06100874?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2023-11-20. Estimated completion is 2027-11-30.

What conditions does trial NCT06100874 study?

This clinical trial studies the following conditions: Breast Cancer Female, Breast Cancer Metastatic, Her 2 Positive Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06100874?

The interventions under investigation include: Trastuzumab (DRUG), Sacituzumab Govitecan (DRUG), Trastuzumab and Hyaluronidase-oysk (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06100874?

This trial is sponsored by Adrienne G. Waks, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06100874 being conducted?

This trial has 4 study locations across Florida, Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial