Northwestern University Feinberg School of Medicine
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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:

Northwestern University
(312) 472-0585

Duke University
Clancy Leahy
(919) 681-2172

Kim Turnage
(919) 681-5559

Memorial Sloan Kettering Cancer Center
(646) 888-5217

Cleveland Clinic
Barbara Bevier
(216) 445-9159

Mayo Clinic
Lisa Seymour
(507) 293-7698

St Elizabeth Hospital
Kimberly Schmidt
(859) 301-9418




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