TerminatedPhase 2

Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma

Stopped: Relocation of Principal Investigator

United States7 participantsStarted 2019-03-01

Plain-language summary

Up to one third of breast cancer patients have hypothyroidism or hyperthyroidism. L-thyroxine (T4), or Synthroid, is the most commonly prescribed agent for the management of hypothyroidism in the US. However, there are data suggesting that triiodothyronine (T3) may have benefits in preventing disease progression over l-thyroxine (T4).

Who can participate

Age range18 Years – 105 Years

SexALL

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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: * Age greater than or equal to 18 * Male or female with diagnosis of metastatic breast carcinoma and documented history of hypothyroidism . * TSH level within normal range at baseline * Life expectancy estimated \> 3 months * Ability and willingness to provide informed consent Exclusion Criteria: * Life expectancy estimated to be less than 3 months * Is currently pregnant or intends to become pregnant during the duration of the study * Active angina, New York Heart Association (NYHA) advanced \[Class III/IV\] congestive heart failure, or uncontrolled cardiac arrhythmia within 6 months of enrollment * History of thyrotoxicosis * History of adrenal insufficiency * Hypersensitivity to any active or extraneous constituents in Triiodothyronine (T3)/liothyronine sodium

What they're measuring

Number of Participants With Progression-free Survival at 12 Months Based Upon Clinical and Radiological Assessments Completed as Part of Routine Care

Timeframe: 12 months

Trial details

NCT IDNCT03787303

SponsorAultman Health Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-09

Results submitted2022-03-17

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