Title Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients
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Principal Investigator Stephen Edge, MD
Study Number 110907
PhasePilot
Summary The patients for this study will have early stage breast cancer that is potentially curable. This type of cancer usually treated with certain hormonal therapy such as Tamoxifen pills in order to reduce the chance of cancer recurrence. Tamoxifen has been shown to reduce the risk of recurrence of hormonal receptor positive breast cancer (also referred to estrogen receptor and progesterone receptor positive breast cancer). However Tamoxifen does not work equally well to everyone and certain patients may develop recurrence despite appropriate therapy. The reasons for failure of tamoxifen in these patients are not fully elucidate and is a subject of intense research. This study will help us better understand the interaction between the hormonal therapy Tamoxifen, estrogen receptors and certain genes in the cancer cell. This knowledge may eventually help us to choose appropriate therapy in the future patients with the same type of cancer.
Eligibility
- The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines
- Biopsy must show invasive carcinoma
- Tumor should be ER receptor positive
- The tumor should be approximately 1cm, but at least 5mm to account for variability in imaging and imaging occult disease
- Patients in whom surgical excision of the tumor is part of standard of care management
- PS less than or equal to 1
- Negative serum or urine b-hCG pregnancy test at screening for patients of childbearing potential and willing to practice suitable contraception for at least 3 months following surgery
- Consent to participate in DBBR