Breast Cancer
Conditions
Keywords
breast cancer
Brief 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.
Interventions
DRUGSNDX-275
Sponsors
Syndax Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate changes in gene and/or protein expression of exploratory biomarkers in invasive breast cancer tissue before and after SNDX-275 administration, as tissue sample permits. | 14 days |
| Evaluate safety and tolerability of SNDX-275 as measured by adverse events and changes in laboratory safety parameters | 14 days |
Countries
United States
Outcome results
None listed