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ACTIVE NOT RECRUITING Phase 2

Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases

NCT04647916 · View on ClinicalTrials.gov ↗

Study Summary

This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse.

Interventions

  • BIOLOGICAL Sacituzumab Govitecan

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine — Anchorage
  • Anchorage Radiation Therapy Center — Anchorage
  • Alaska Breast Care and Surgery LLC — Anchorage
  • Alaska Oncology and Hematology LLC — Anchorage
  • Alaska Women's Cancer Care — Anchorage
  • Anchorage Oncology Centre — Anchorage
  • Katmai Oncology Group — Anchorage
  • Providence Alaska Medical Center — Anchorage
  • Fairbanks Memorial Hospital — Fairbanks

California

  • Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank
  • UC Irvine Health Cancer Center-Newport — Costa Mesa
  • Epic Care-Dublin — Dublin
  • Bay Area Breast Surgeons Inc — Emeryville

Arizona

  • Cancer Center at Saint Joseph's — Phoenix
  • University of Arizona Cancer Center-Orange Grove Campus — Tucson
  • Banner University Medical Center - Tucson — Tucson
  • University of Arizona Cancer Center-North Campus — Tucson

Arkansas

  • Mercy Hospital Fort Smith — Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs — Hot Springs

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2021-06-08
Est. Completion 2028-12
Phase Phase 2

Sponsor

SWOG Cancer Research Network

212 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04647916

The ClinicalTrials.gov registry entry for NCT04647916 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 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 1 intervention — of which Sacituzumab Govitecan 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: NCT04647916 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Alaska, California, Arizona. 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 NCT04647916 about?

NCT04647916 is a clinical study titled "Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases". This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a...

What is the current status of trial NCT04647916?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2021-06-08. Estimated completion is 2028-12.

What conditions does trial NCT04647916 study?

This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Prognostic Stage IV Breast Cancer AJCC v8, Metastatic HER2 Negative Breast Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04647916?

The interventions under investigation include: Sacituzumab Govitecan (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04647916?

This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04647916 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California. 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