Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Si… (NCT04570956) | Clinical Trial Compass
TerminatedPhase 2
Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer Risk
Stopped: grant and funding expired
United States65 participantsStarted 2021-07-26
Plain-language summary
The investigators plan to prospectively study breast tissue changes after a short course of Tamoxifen (Tam).
Who can participate
Age range18 Years – 80 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:
* 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 lobular carcinoma in situ (LCIS), within the last 12 months, whether surgically excised or not.; OR neither AH nor LCIS but increased breast cancer risk defined as either:
* Gail model (Breast Cancer Risk Assessment Tool) 5 year breast cancer risk of \>= 3%, or
* International Breast Intervention Study model 10 year breast cancer risk of \>= 5%.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
* The effects of topical afimoxifene (4-OHT) gel on the developing human fetus at the recommended therapeutic dose are unknown. However, oral tamoxifen is Pregnancy Category D-positive evidence of human fetal risk. For this reason, and because triphenylethylene antiestrogens, including tamoxifen, are known to be teratogenic, women of childbearing potential and their male partners must agree to use at least 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 (participant can resume oral birth control pills for effective birth control measures after post-treatment biopsy …
What they're measuring
1
The purpose of this research is to evaluate short-term changes in background breast tissue induced by oral tamoxifen or 4-OHT gel in women with atypical hyperplasia or lobular carcinoma in situ (LCIS).