Actively Recruiting
A Phase II Trial to Evaluate Trastuzumab Deruxtecan With or Without Anastrozole for 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
N/A
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
Researchers are evaluating trastuzumab deruxtecan alone or combined with anastrozole for treating patients with early-stage HER2 low, hormone receptor positive breast cancer. This phase II trial aims to find which treatment shows the strongest effect based on the pathologic complete response rate and to assess safety, molecular tumor changes, and quality of life during treatment. Participants are randomly assigned to one of two groups. One group receives trastuzumab deruxtecan intravenously every 21 days for up to six cycles, followed by surgery. The second group receives the same trastuzumab deruxtecan treatment plus daily oral anastrozole during each 21-day cycle, also followed by surgery. After completing treatment, patients have a follow-up visit 21 to 28 days later. During the study, patients undergo various assessments including tumor biopsies, molecular biomarker tests, and quality of life questionnaires. Researchers monitor adverse events from the first treatment cycle through study completion, usually about six months. The main outcome measured is the pathologic complete response rate from baseline to surgery, along with other tumor and biomarker analyses.
CONDITIONS
Brief 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 larger than 2.0 cm
- Clinical node negative or positive disease deemed operable
- In the United States
- Tumor is HER2-low (IHC 1+ or 2+) confirmed locally or centrally
- If HER2 is 2+, FISH must show no HER2 amplification
- Tumor is hormone receptor positive per guidelines
- ECOG performance status of 0 or 1
- Normal heart function with LVEF ≥ 50% within 28 days before enrollment
- Platelet count ≥ 100,000/mm³ within 14 days before enrollment
- Hemoglobin ≥ 9.0 g/dL within 14 days before enrollment
- Absolute neutrophil count ≥ 1500/mm³ within 14 days before enrollment
- Creatinine clearance ≥ 30 mL/min or serum creatinine ≤ 1.5x ULN within 14 days before enrollment
- ALT and AST ≤ 3x ULN within 14 days before enrollment
- Total bilirubin ≤ 1.5x ULN (or ≤ 2.0x ULN with Gilbert's syndrome) within 14 days before enrollment
- Serum albumin ≥ 2.5 g/dL within 14 days before enrollment
- INR/PT and aPTT ≤ 1.5x ULN within 14 days before enrollment
- Adequate treatment washout period before enrollment
- Negative pregnancy test for women of childbearing potential
- Agreement to use highly effective contraception during and after study
- Postmenopausal or pre/perimenopausal with ovarian function suppression started 28 days before treatment
You will not qualify if you...
- Recurrent or metastatic breast cancer
- Bilateral breast cancer
- 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 or symptomatic heart failure
- Unable to swallow oral medications
- Pregnant, lactating, or planning pregnancy
- Prolonged QT interval on ECG
- Hypercoagulable disorder requiring anticoagulants
- Significant gastrointestinal disorders affecting oral medication absorption
- History or current interstitial lung disease or pneumonitis
- Multiple primary malignancies within 3 years except certain treated cancers
- Other anti-cancer therapy concurrent with study treatment
- Substance abuse or medical conditions interfering with participation
- Known HIV or active hepatitis B or C infection
- Recent serious cardiovascular events
- Prior stem-cell transplant
- Active systemic infections requiring IV antibiotics
- Concurrent ovarian hormone replacement therapy
- History of severe hypersensitivity to monoclonal antibodies or study drugs
- Severe pulmonary compromise
- Life expectancy less than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles of 21 days each)
Participants receive trastuzumab deruxtecan intravenously every 21 days for up to 6 cycles. Participants in one arm also take anastrozole orally once daily during each 21-day cycle. Treatment continues in the absence of disease progression or unacceptable toxicity.
6 visits (in-person) every 21 days
Duration - 1 week
Participants undergo surgery after completing study treatment to remove the tumor and assess response to therapy.
1 visit (in-person)
Duration - 3 to 4 weeks
Participants are followed up to monitor safety and recovery after surgery and treatment completion.
1 visit (in-person)
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
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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