RecruitingPhase 2NCT04553770

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

A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

88 participants

Start Date

Oct 9, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a targeted drug called trastuzumab deruxtecan — alone or combined with a hormone-blocking drug (anastrozole) — can shrink breast tumors before surgery in women with early-stage, hormone-sensitive, HER2-low breast cancer. **You may be eligible if...** - You have early-stage invasive breast cancer larger than 2 cm - Your tumor is HER2-low (a specific low level of the HER2 protein) and hormone receptor-positive - You have not yet been treated for this breast cancer - You have good heart function (ejection fraction 50% or higher) - You are in good general health **You may NOT be eligible if...** - Your tumor is HER2-negative (zero expression) or HER2-positive (high expression) - Your cancer has spread beyond the breast to distant parts of the body - You have significant heart, lung, or other organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnastrozole

Given PO

PROCEDURETherapeutic Conventional Surgery

Undergo surgery

BIOLOGICALTrastuzumab Deruxtecan

Given IV


Locations(9)

St. Joseph Heritage Healthcare

Fullerton, California, United States

Cancer Blood and Specialty Clinic

Los Alamitos, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Torrance Memorial Physician Network / Cancer Care

Torrance, California, United States

PIH Health

Whittier, California, United States

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

Orlando, Florida, United States

Ft. Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT04553770


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