A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ
Johns Hopkins Kimmel Cancer Center in Baltimore
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
Inclusion:• Women must have newly diagnosed histologically confirmed ER (+) DCIS scheduled to undergo surgical therapy. The pathology report (signed pathology report from attending pathologist) from each individual institution will be used to determine eligibility.• DCIS must be equal to 1cm based on extent of calcifications, presence of a mass on ultrasound OR enhancement on MRIORDCIS must be equal to 5mm of DCIS on one single core. Can be less than 5mm if DCIS is identified on multiple cores (at least 2 cores)• Women presenting after excision with positive margins are eligible. Ki-67, Cox-2, P-16, expression in immediately adjacent tissue is similar to what is found in DCIS.• Women must be postmenopausal (defined as no menstrual cycle for 12 months or surgical history of bilateral salpingoopherectomy). Postmenopausal women of all races and ethnic groups are eligible to participate for this trial. Men are not eligible.• Women in the age range of equal to 18-75 (inclusive)• ECOG performance status equal to 2 • Patients must have normal organ and marrow function as defined below• Patients must have the ability to swallow oral medication• Ability to understand and the willingness to sign a written informed consent document and comply with all procedures
This is a randomized prevention study with a total enrollment of 140 participants. Patients will be randomized to one of two arms; Arm I or Arm II.Patients on Arm I receive conjugated estrogens/bazedoxifene orally (PO) once daily (QD) for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. Patients on Arm II receive placebo PO QD for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. After completion of study treatment, patients are followed up for 30 days.
03/05/2019 05:03 AM