Metastatic Breast Cancer Clinical Trial
— B-TREUHOfficial title:
A Single Arm Phase II Pilot Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma
Verified date | May 2022 |
Source | Aultman Health Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 7 |
Est. completion date | March 9, 2022 |
Est. primary completion date | March 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 105 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Aultman Medical Group Hematology and Oncology | Canton | Ohio |
Lead Sponsor | Collaborator |
---|---|
Aultman Health Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Progression-free Survival at 12 Months Based Upon Clinical and Radiological Assessments Completed as Part of Routine Care | To prospectively evaluate the progression-free survival in hypothyroid patients with metastatic breast carcinoma who are rendered euthyroid and hypothyroxinemic. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the nadir sum of the longest diameter (SLD) of target lesions, or unequivocal progression (overall level of substantial worsening) in existing non-target lesions, or the appearance of one or more new lesions. | 12 months | |
Secondary | Number of Patients With Both Metastatic Breast Cancer and Hypothyroidism in All Screened Patients. | To quantitate the prevalence of hypothyroidism in metastatic breast cancer patients at a community oncology practice. | Study duration, planned was 48 months but actual was 36 months [March 1, 2019 to March 9, 2022] due to premature closure due to planned relocation of the PI. | |
Secondary | Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire | Functional Assessment of Cancer Therapy - Breast (FACT-B) Total Score comprised of Physical Well Being (PWB), Social Well Being (SWB), Emotional Well Being (EWB), Functional Well Being (FWB), and Breast Cancer Subscale (BCS). Range is 0-148. A higher score indicates higher quality of life. Missing scores were handled by prorating values. | Baseline, 3, 6, 9, and 12 months | |
Secondary | Measurement of Energy Level Across Time Using FACT-B Question. | Functional Assessment of Cancer Therapy - Breast (FACT-B) Lack of energy on 5 point Likert scale as measured on FACT-B Physical Well-being subscale. Score of 0 indicates no lack of energy with score of 4 indicating total lack of energy. | Baseline, 3, 6, 9, 12 months | |
Secondary | Time to Achieve Euthyroid Hypothyroxinemia State | To study the average time required to achieve euthyroid hypothyroxinemia state in qualifying patients. Thyroid function laboratory testing was performed at baseline and then at every 4 weekly intervals until 12 weeks then every 3 monthly thereafter, unless thyroid-stimulating hormone (TSH) was abnormal. If a normal TSH level was not achieved by the 12 week visit, repeat TSH measurements were ordered every 4-6 weeks until the TSH value was within the laboratory normal reference range. Initial euthyroid state defined by number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value. | Number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value for each participant, assessed up to 12 months |
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