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RECRUITING Phase 2

Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

NCT04553770 · View on ClinicalTrials.gov ↗

Study Summary

This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.

Interventions

  • DRUG Anastrozole
  • PROCEDURE Therapeutic Conventional Surgery
  • BIOLOGICAL Trastuzumab Deruxtecan

Study Locations (9)

California

  • St. Joseph Heritage Healthcare — Fullerton
  • Cancer Blood and Specialty Clinic — Los Alamitos
  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles
  • Torrance Memorial Physician Network / Cancer Care — Torrance
  • PIH Health — Whittier

Florida

  • Orlando Health, Inc. d/b/a Orlando Health UF Health Center — Orlando

Indiana

  • Ft. Wayne Medical Oncology and Hematology, Inc. — Fort Wayne

Kansas

  • Cancer Center of Kansas — Wichita

Massachusetts

  • Massachusetts General Hospital — Boston

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2020-10-09
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

Jonsson Comprehensive Cancer Center

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04553770

The ClinicalTrials.gov registry entry for NCT04553770 describes a study currently listed as 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 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jonsson Comprehensive Cancer Center, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Stage II Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Anastrozole 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: NCT04553770 reports 9 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Indiana. 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 NCT04553770 about?

NCT04553770 is a clinical study titled "Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer". This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called derux...

What is the current status of trial NCT04553770?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2020-10-09. Estimated completion is 2026-12-31.

What conditions does trial NCT04553770 study?

This clinical trial studies the following conditions: Stage II Breast Cancer, Invasive Breast Cancer, Stage III Breast Cancer, Stage IIA Breast Cancer, Stage IIB 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 NCT04553770?

The interventions under investigation include: Anastrozole (DRUG), Therapeutic Conventional Surgery (PROCEDURE), Trastuzumab Deruxtecan (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04553770?

This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04553770 being conducted?

This trial has 9 study locations across California, Florida, Indiana, Kansas, Massachusetts. 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