Actively Recruiting
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-11-10
88
Participants Needed
9
Research Sites
324 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
T
Translational Research in Oncology-U.S
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated operable invasive breast cancer greater than 2.0 cm in size
- Clinical node negative or positive disease deemed operable
- No distant metastasis confirmed by staging
- Tumor is HER2-low by immunohistochemistry (IHC 1+ or 2+ with non-amplified FISH if 2+)
- Hormone receptor positive tumor
- ECOG performance status 0 or 1
- Normal cardiac function with LVEF \u2265 50% within 28 days before enrollment
- Platelet count \u2265 100,000/mm\u00b3 within 14 days before enrollment
- Hemoglobin \u2265 9.0 g/dL within 14 days before enrollment
- Absolute neutrophil count \u2265 1500/mm\u00b3 within 14 days before enrollment
- Creatinine clearance \u2265 30 mL/min or serum creatinine \u2264 1.5 x ULN within 14 days before enrollment
- ALT and AST \u2264 3 x ULN within 14 days before enrollment
- Total bilirubin \u2264 1.5 x ULN (or \u2264 2.0 x ULN with Gilbert's syndrome) within 14 days before enrollment
- Serum albumin \u2265 2.5 g/dL within 14 days before enrollment
- INR/PT and aPTT \u2264 1.5 x ULN within 14 days before enrollment
- Adequate washout period before enrollment (major surgery \u2265 4 weeks, chloroquine/hydroxychloroquine >14 days)
- Negative pregnancy test for women of childbearing potential
- Agreement to use highly effective contraception during and after the study for reproductive participants
- No sperm donation for males during and 4 months after study
- No ovum donation for females during and 7 months after study
- Estradiol levels in postmenopausal range prior to baseline biopsy
- Premenopausal or perimenopausal women amenable to ovarian function suppression treatment started at least 28 days before dosing
You will not qualify if you...
- Recurrent or metastatic breast cancer
- Bilateral breast cancer (multifocal or multicentric allowed if HER2-low and HR-positive)
- Inflammatory breast cancer
- Prior systemic therapy for invasive cancer (except tamoxifen for DCIS)
- Prior ipsilateral chest wall radiation
- Major surgery less than 4 weeks before enrollment
- Recent myocardial infarction within 6 months or symptomatic congestive heart failure
- Unable to swallow oral medications
- Pregnant, lactating, or planning pregnancy
- Prolonged QT interval on ECG
- Known hypercoagulable disorder requiring anticoagulants
- Significant gastrointestinal disorders affecting oral medication
- History or presence of interstitial lung disease or pneumonitis
- Multiple primary malignancies within 3 years except certain treated non-breast cancers
- Concurrent anti-cancer therapy excluding ovarian suppression or bone modifying agents
- Substance abuse or significant medical/psychological conditions interfering with study
- Known HIV infection or active hepatitis B or C infection
- Recent serious cardiac arrhythmias or cardiac arrest
- Prior stem-cell transplant
- Active systemic infections requiring IV antibiotics
- Current ovarian hormonal replacement therapy
- History of severe hypersensitivity to monoclonal antibodies or study drugs
- Severe pulmonary compromise or autoimmune pulmonary disorders
- Life expectancy less than 3 months
AI-Screening
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Trial Site Locations
Total: 9 locations
1
St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
Actively Recruiting
2
Cancer Blood and Specialty Clinic
Los Alamitos, California, United States, 90720
Actively Recruiting
3
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
4
Torrance Memorial Physician Network / Cancer Care
Torrance, California, United States, 90602
Actively Recruiting
5
PIH Health
Whittier, California, United States, 90602
Actively Recruiting
6
Orlando Health, Inc. d/b/a Orlando Health UF Health Center
Orlando, Florida, United States, 32806
Withdrawn
7
Ft. Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46804
Withdrawn
8
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
Actively Recruiting
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
T
TRIO-US
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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