Study Summary
This trial is investigating whether trastuzumab deruxtecan, either alone or in combination with anastrozole, is effective in treating patients with HER2 low, hormone receptor positive breast cancer.
Eligible Conditions
- Hormone Receptor Positive Breast Cancer
- Stage IIA Breast Cancer
- Breast Cancer, Stage III
- Breast Cancer, Stage II
- Stage IIB Breast Cancer
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Baseline to surgery
Baseline to surgery
Biomarker analyses
Clinical objective response
Molecular changes in tumor biomarkers including Ki67 expression
Pathologic complete response (pCR) rate
Month 6
Quality of life assessment: questionnaire
Month 6
Incidence of adverse events
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Arm A (trastuzumab deruxtecan)
1 of 2
Arm B (trastuzumab deruxtecan, anastrozole)
1 of 2
Active Control
Experimental Treatment
88 Total Participants · 2 Treatment Groups
Primary Treatment: Trastuzumab Deruxtecan · No Placebo Group · Phase 2
Arm B (trastuzumab deruxtecan, anastrozole)Experimental Group · 3 Interventions: Anastrozole, Trastuzumab Deruxtecan, Therapeutic Conventional Surgery · Intervention Types: Drug, Biological, Procedure
Arm A (trastuzumab deruxtecan)ActiveComparator Group · 2 Interventions: Trastuzumab Deruxtecan, Therapeutic Conventional Surgery · Intervention Types: Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrozole
FDA approved
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to surgery
Who is running the clinical trial?
Daiichi Sankyo Co., Ltd.Industry Sponsor
113 Previous Clinical Trials
48,665 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
339 Previous Clinical Trials
21,639 Total Patients Enrolled
Translational Research in Oncology-U.SUNKNOWN
Sara A HurvitzPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:People who have lymph nodes that are clinically involved should not have radiological evidence of distant disease according to the standard of care staging prior to signing the patient informed consent form (PICF).
The subject's cardiac function is normal (left ventricular ejection fraction [LVEF] is >= 50%) based on an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization/enrollment.
They will not allow you to have a blood transfusion if your hemoglobin levels are 9.0 g/dL or higher.
The patient must have an ANC of at least 1500/mm3 and not have received G-CSF within the week before the screening assessment.
The subject must have a platelet count of at least 100,000/mm3 prior to screening
, the President is the head of state
A cancer that is 2.0 cm or larger, based on a physical exam or imaging, that has not been treated before
The tumor is HR positive, as per the ASCO CAP guidelines, and the estrogen and progesterone receptor statuses are known
This text refers to a measure of a person's ability to carry out usual activities, called the Eastern Cooperative Oncology Group (ECOG) performance status
Tumor is HER2-low by immunohistochemistry (IHC), defined as 1+ or 2+, confirmed by central testing (central testing results not required for enrollment, unless no local results available).
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Conditions
Cancer Related
Treatments