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

NCT04553770 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-11-10

No results posted yet for this 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.

Conditions

Interventions

DRUG

Anastrozole

Given PO

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

BIOLOGICAL

Trastuzumab Deruxtecan

Given IV

Sponsors & Collaborators

  • Translational Research in Oncology-U.S

    collaborator UNKNOWN

  • Daiichi Sankyo Co., Ltd.

    collaborator INDUSTRY

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Nicholas P McAndrew, MD · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04553770 on ClinicalTrials.gov