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 range
18 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute Change in Ki-67 Expression in Breast Epithelial Cells of Patients Treated With 9cUAB30