Study on Combining Chemotherapy, Endocrine Therapy, and HER2-Targeted Therapy Before Surgery in HER2+ Breast Cancer
Sponsor: Legacy Health System
Sponsor score: 0
ClinicalTrials ID:NCT07506876
This clinical trial is exploring whether adding endocrine therapy to the usual chemotherapy and HER2-targeted treatment can improve the response in patients with hormone receptor positive, HER2 positive breast cancer before surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
The standard treatment for hormone receptor positive, HER2 positive breast cancer typically involves chemotherapy and HER2-targeted therapy, followed by endocrine therapy and surgery. This study aims to find out if starting endocrine therapy alongside chemotherapy and HER2-directed therapy can enhance the effectiveness of the treatment before surgery.
Eligibility Criteria
Inclusion Criteria
- Adults over 18 years old with newly diagnosed, untreated hormone receptor positive (HR+), HER2 positive breast cancer.
- Endocrine therapy for the current breast cancer can be started up to 28 days before joining the trial and must begin before the second cycle of chemotherapy/HER2-directed therapy.
- The type of endocrine therapy will be decided by the treating doctor.
- Patients should have Stage IIA to IIIC breast cancer and plan to undergo at least 4 cycles of a specific chemotherapy regimen (TCHP).
- Patients must have a specific breast cancer subtype (Luminal A, Luminal B, or HER2 enriched) as determined by a test on the initial biopsy.
Exclusion Criteria
- Individuals under 18 years old, pregnant women, prisoners, and adults who cannot make decisions for themselves.
- Patients who have had any other type of cancer in the past 2 years.
- Patients who have had breast cancer in the past 5 years.
- Patients with recurrent breast cancer.
- Patients with Stage IV breast cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Legacy Mount Hood Medical Center | 97030 | Gresham | Oregon |
| Legacy Good Samaritan Medical Center | 97210 | Portland | Oregon |
| Legacy Meridian Park Medical Center | 97062 | Tualatin | Oregon |
| Legacy Salmon Creek Medical Center | 98686 | Vancouver | Washington |
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