A Phase IIB Randomized Trial of Oral Tamoxifen vs. Topical 4-hydroxytamoxifen Gel vs. Control in Women with Atypical Hyperplasia or Lobular Carcinoma In Situ
A Study to Evaluate Oral Tamoxifen vs. TamGel vs. Control in Women with Atypical Hyperplasia or Lobular Carcinoma In Situ
- Willing to return to enrolling institution for follow-up.
- Willing to complete required testing.
- Ability to complete questionnaire by themselves or with assistance.
- Female (sex that was assigned at birth).
- Ipsilateral intact breast with histology confirmation of atypical ductal or lobular hyperplasia, or LCIS, within the last 12 months, whether surgically excised or not.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Willingness to agree to use ONE effective form of birth control (abstinence is not an allowed method) prior to study entry and for the duration of study participation, and for 2 months following the last dose of study medications. Effective birth control methods are:
- copper IUD [intrauterine device];
- diaphragm/cervical cap/shield;
- contraceptive sponge;
- Women of childbearing potential must have a negative pregnancy test within five days before starting study medications. Should a participant become pregnant or suspect she is pregnant while participating in this study; the participant should inform the study physician immediately.
- Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e., tanning beds) for the duration of the study.
- Participants must have acceptable organ and marrow function as defined below within 30 days of randomization: judged by treating physician's evaluation of baseline laboratory data.
- Negative urine pregnancy test, if of childbearing potential and / or FSH to verify menopausal status.
- Clinically suspicious mass/lesions.
- Breast cancer in the past 5 years.
- Prior thromboembolism within last 5 years (history of varicose veins and superficial phlebitis is allowed).
- Current pregnancy or lactation.
- History of other prior breast cancer-specific therapy within the previous 2 years (chemotherapy, anti-HER2 agents, endocrine agents, everolimus, CDK4-6 inhibitors).
- Cytotoxic chemotherapy for any indication in last 2 years.
- Prior use of SERMS or AIs including tamoxifen, raloxifene, anastrozole, letrozole, or exemestane for prevention or therapy within 5 years.
- Exogenous sex steroid, including oral contraceptive pill use within 1 month prior to research core needle biopsy (CNB).
- Use of vaginally administered estrogens and hormone coated IUD such as Mirena is permitted.
- History of any prior ipsilateral breast radiotherapy. Previous unilateral radiation of the contralateral side is allowed.
- Skin lesions on the breast that disrupt the stratum corneum (e.g., eczema, ulceration).
- History of endometrial neoplasia.
- Current smoker. Cessation for at least 6 weeks.
- Current users of potent inhibitors of tamoxifen metabolism. The potent inhibitors of tamoxifen metabolism are: bupropion, cinacalcet, fluoxetine, paroxetine, quinidine.
- Participants may not be receiving any other investigational agents within 90 days of enrollment or during this study.
- History of allergic reactions to tamoxifen.
- Uncontrolled intercurrent illness that in the judgement of the treating physician would make them unsuitable for study participation.
- Anticoagulation meds and clinical concern for discontinuing meds for study research biopsy.
- Identification of a clinically suspicious mass on examination.
Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.
Therapeutic and Side Effects of Invasive and Noninvasive Brain Stimulation
A Study to Evaluate Therapeutic and Side Effects of Brain Stimulation
Key Inclusion Criteria:
Patients that receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes and brain tumors.
Key Exclusion Criteria:
Patients that do not receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes, and brain tumors.