Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer (NCT03323658) | Clinical Trial Compass
CompletedPhase 1
Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer
United States24 participantsStarted 2018-06-15
Plain-language summary
This phase I trial studies the side effects and best dose of bexarotene in preventing breast cancer in patients at high risk for breast cancer. Bexarotene belongs to a class of drugs that are called rexinoids, and it may reduce the incidence of breast tumors.
Who can participate
Age range18 Years
SexFEMALE
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:
* Participants must be at high risk as defined by a history of breast cancer (invasive or ductal breast carcinoma in situ \[DCIS\]) and be at least 5 years out from diagnosis, or lobular carcinoma in situ (LCIS), or proliferative benign breast disease such atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH) or genetic test confirmation of BRCA 1/2 mutation carrier or have a breast cancer risk assessment \>= 1.7% in 5 years or a lifetime risk \>= 20%
* No evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator; diagnosis of invasive cancer must be at least 5 years prior to initiation on trial
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
* Leukocytes \>= 3,000/microliter
* Absolute neutrophil count \>= 1,500/microliter
* Platelets \>= 100,000/microliter
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional upper limit of normal (ULN)
* Creatinine =\< 1.5 x institutional ULN
* Hemoglobin \>= 10 g/dL
* Thyroid-stimulating hormone (TSH) within normal institutional limits
* Triglycerides =\< 300 mg/dl
* Total cholesterol =\< 300 mg/dl
* \>= 6 months from all previous breast cancer treatment (including endocrine therapy)
* Particip…
What they're measuring
1
Number of Participants With Incidence of Adverse Events (Dose Limiting Toxicities)
Timeframe: 4 weeks of treatment, Up to 30 days after completion of study drug for AE assessments