A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: SNDX-275


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ER positive | Drug: SNDX-275<br> <br> |
| Experimental: 2<br>ER negative and/or PR negative histology | Drug: SNDX-275<br> <br> |
| Experimental: 3<br>triple negative histology (for ER, PR, HER-2) | Drug: SNDX-275<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate changes in the expression of targeted biomarkers in invasive breast cancer tissue before and after SNDX-275 administration |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer