Clinical trial · Interventional
A Phase I, Multicenter, Open Label Study on the Effects of SNDX-275 on Expression of Biomarkers in Subjects With Newly Diagnosed Breast Cancer
NCT00754312CI-TRIAL-00058919terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNDX-275 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- ER positive
- interventionNames
- Drug: SNDX-275
- type
- EXPERIMENTAL
- label
- 2
- description
- ER negative and/or PR negative histology
- interventionNames
- Drug: SNDX-275
- type
- EXPERIMENTAL
- label
- 3
- description
- triple negative histology (for ER, PR, HER-2)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.