NWU2015-06-04 - TopTam2
Phase IIB Pre-Surgical Trial of Oral Tamoxifen Versus Transdermal 4-Hydroxytamoxifen in Women with DCIS of the Breast
Finding Alternatives for DCIS Treatment: Tamoxifen taken by mouth versus a gel applied directly to the breast before surgery
Why Is This Study Being Done?
- Treatment of DCIS usually involves surgery, then radiation, often followed by tamoxifen taken as a pill by mouth.
- Many women hesitate to take pills after surgery because of the possibility of side effects.
- We are testing a medicated gel containing an active form of tamoxifen (4-OHT) that can be applied to the breast skin and will go directly to the breast.
- Previous studies show that this stays mainly in the breast and very little gets into the blood.
- This study is looking at whether the gel will work as well as tamoxifen pills, but with fewer side effects.
You May Be Eligible To Participate If You:
- Have been diagnosed with ER positive DCIS.
- Are not pregnant or breastfeeding.
- Have no history of uterine cancer or blood clots.
- Have not taken tamoxifen or a similar drug within 5 years.
You Will Receive
- Treatment for 6 to 10 weeks before surgery.
- Optional peer-to-peer counseling with ABCD (After Breast Cancer Diagnosis).
- Up to $300 compensation for your time and extra expenses (childcare, travel, absence from work, etc.).
- OncotypeDX Breast DCIS Scoreto discuss with your doctor, to help you decide whether to take radiation or not.
If You Take Part in This Study, You Will
- Start with an office visit, give a blood sample, and complete a short questionnaire.
- Take a pill and apply a gel to both breasts daily for up to 10 weeks before surgery.
- Have phone calls with us to check in (weeks 1, 2, 4, and 8.
- Come back the day of surgery, for a blood sample, and a short questionnaire.
- At surgery, we will take a small sample of breast tissue to measure the amount of tamoxifen present.
- At your usual post-surgery visit you will complete a short assessment.
If you would like to learn more about this study, please contact the study coordinators:
Memorial Sloan Kettering Cancer Center
St Elizabeth Hospital
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