Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer (NCT02876640) | Clinical Trial Compass
TerminatedPhase 1
Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer
Stopped: Inadequate Accrual Rate
United States27 participantsStarted 2018-03-16
Plain-language summary
This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a necessary feature of agents under development for cancer prevention.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female only. The sample size of males affected by breast cancer is limited, hence we will not be able to collect significant data for analysis of the effect of study drug on breast cancer in males
* Age \>= 18 years. Because no dosing or adverse event data is currently available on the use of 9cUAB30 in participants \<18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 or Karnofsky \>= 70%
* Invasive breast cancer diagnosed by needle core biopsy between 0.5 cm and 5 cm in size based on imaging, that is estrogen receptor positive (ER+) or estrogen receptor negative (ER-), Her2neu positive or negative OR ductal carcinoma in situ (DCIS) of the breast diagnosed by core needle biopsy and at least 1.0 cm in size based on imaging. Grade 3 ER+ DCIS will be allowed as well as ER- DCIS of any grade. For DCIS-only lesions, the imaging abnormality corresponding to the cancer must be at least 1.0 cm in size (i.e. calcifications, distortion or mass on mammogram, or mass or non-mass enhancement on magnetic resonance imaging \[MRI\])
* White blood cells (WBC) \>= 3000/mm\^3
* Platelets \>= 100,000/mm\^3
* Hemoglobin \> 10 g/dL
* Bilirubin =\< upper limit of institutional normal
* Aspartate aminotransferase (AST) =\< upper limit of institutional normal
* Creatinine =\< upper limit of institutional normal
* Triglycerides =\< 1.5 x upper limit of normal (ULN)
* Cholesterol =\< 1.5 x ULN
* Participants must agree to discontinue all suppleme…
What they're measuring
1
Absolute Change in Ki-67 Expression in Breast Epithelial Cells of Patients Treated With 9cUAB30