Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients (NCT01027416) | Clinical Trial Compass
CompletedNot Applicable
Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients
United States59 participantsStarted 2009-12-14
Plain-language summary
This study will help to understand the interaction between estrogen receptor-alpha (ER alpha) and tumor suppressor protein p53 as well as impact on patient tumor gene expression in response to the hormonal therapy Tamoxifen. This information may eventually help select the appropriate therapy for future patients with similar cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines
✓. The patient must be 18 years or older.
✓. Core biopsy should definitively demonstrate invasive carcinoma.
✓. Invasive carcinoma should be ER-apha receptor positive
✓. The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible.
✓. Patients in whom surgical excision of the tumor is part of standard of care management
✓. ECOG score of 0 or 1
✓. Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)
Exclusion criteria
✕. Male patients are not eligible for this study
✕. Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan.
✕. Patients with diagnosis by FNA cytology only
What they're measuring
1
Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm