Clinical trial · Interventional
Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma
A Single Arm Phase II Pilot Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma
NCT03787303CI-TRIAL-00058482B-TREUHterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Relocation of Principal Investigator
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Thyroid Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Triiodothyronine (T3) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Triiodothyronine (T3)
- description
- Following discontinuation of L-thyroxine (T4), triiodothyronine (T3) will be initiated at a 3:1 ratio. The dose will be titrated by the investigator to maintain levels of free T4 \< 50% of normal range while maintaining a euthyroid state. Triiodothyronine (T3) tablets for oral administration will be prescribed once or twice daily depending on the total dose. Treatment duration will be approximately 9 months during which time the subjects will continue to be treated and monitored as usual for their metastatic breast cancer. During the study period and at the conclusion of the study period, there will be continuous evaluations of the disease status and thyroid status with the option of resuming the original thyroid replacement or continuation of the triiodothyronine (T3).
- interventionNames
- Drug: Triiodothyronine (T3)
Primary outcomes (1)
- measure
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 105 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.