Breast Cancer Clinical Trial
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
Summary
The primary objective of the study is to evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration.
Eligibility Criteria
Inclusion criteria:
Is scheduled for breast biopsy due to a suspicious mass palpable or ≥1 cm on mammogram
Must be able to receive two doses of study medication 7 days apart prior to surgery
Has histologically confirmed invasive breast cancer with ER positive, ER and/or PR negative histology or triple negative (for ER, PR, HER-2) histology
Has an ECOG performance status ≤ 2
Has no clinically significant laboratory or cardiac abnormalities
Has a negative serum pregnancy test at Screening as is either post menopausal, sterile or willing to use an approved method of contraception.
Is able to swallow and retain oral medication
Exclusion criteria:
Has a concomitant medical condition that precludes adequate study treatment compliance or assessment, such as: a. Bleeding disorders that would increase risks of additional core biopsy for biomarkers b. Morbid obesity
Is currently receiving treatment with a medication on the prohibited medication list
Has allergy to benzamides or inactive components of study drug
Is participating in another clinical trial or has received another investigational agent within 30 days prior to informed consent
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There is 1 Location for this study
Indianapolis Indiana, , United States
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