OncoMatch/Clinical Trials/NCT04553770
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
Is NCT04553770 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab Deruxtecan and Anastrozole for invasive breast cancer.
Treatment: Anastrozole · Trastuzumab Deruxtecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) low expression (IHC 1+ or 2+ (if 2+, FISH non-amplified))
Tumor is HER2-low by immunohistochemistry (IHC), defined as 1+ or 2+, confirmed by central testing... If HER2 is 2+ by IHC, FISH must be performed... and the FISH result must be HER2 non-amplified
Required: ESR1 positive
Tumor is HR positive (HR+) per ASCO CAP guidelines with known estrogen and progesterone receptor status, locally defined
Required: PR (PGR) positive
Tumor is HR positive (HR+) per ASCO CAP guidelines with known estrogen and progesterone receptor status, locally defined
Disease stage
Required: Stage II, IIA, IIB, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy for invasive cancer
Exception: Prior tamoxifen for history of ductal breast carcinoma in situ (DCIS) allowed, but no prior aromatase inhibitor, no prior chemotherapy and no prior HER2-targeted therapy
Prior systemic therapy for invasive cancer
Cannot have received: ipsilateral chest wall radiation
Prior ipsilateral chest wall radiation
Lab requirements
Blood counts
Platelet count >= 100,000/mm^3 (no transfusion within 1 week); hemoglobin >= 9.0 g/dL (no transfusion within 1 week); ANC >= 1500/mm^3 (no G-CSF within 1 week)
Kidney function
Creatinine clearance >= 30 mL/min (Cockcroft-Gault) or serum creatinine <= 1.5 x ULN
Liver function
ALT, AST <= 3 x ULN; total bilirubin <= 1.5 x ULN (Gilbert's syndrome: total bilirubin <= 2.0 x ULN and direct bilirubin within normal limits); serum albumin >= 2.5 g/dL
Cardiac function
Normal cardiac function (LVEF >= 50%) by ECHO or MUGA within 28 days before randomization/enrollment
Normal cardiac function (left ventricular ejection fraction [LVEF] >= 50%)... Platelet count >= 100 000/mm^3... Hemoglobin >= 9.0 g/dL... ANC >=1500/mm^3... Creatinine clearance >= 30 mL/min... ALT, AST <= 3 x ULN... Total bilirubin <= 1.5 x ULN... Serum albumin >= 2.5 g/dL... INR/PT and aPTT <= 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Joseph Heritage Healthcare · Fullerton, California
- Cancer Blood and Specialty Clinic · Los Alamitos, California
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, California
- Torrance Memorial Physician Network / Cancer Care · Torrance, California
- PIH Health · Whittier, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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