Trial · NCT03787303
Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma
NCT03787303, Phase 2, Terminated, Aultman Health Foundation; results first posted 2022-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma. Trials, record NCT03787303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03787303
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma
- NCT number
- NCT03787303
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Aultman Health Foundation
- Conditions
- Metastatic Breast Cancer, Thyroid Dysfunction
- Interventions
- Triiodothyronine (T3)
- First posted
- 2018-12-26
- Last updated
- 2022-05-13
- Results first posted
- 2022-05-13
- Limitations and caveats
- Limitation is small sample size due to pandemic affecting clinical trial accrual. A larger sample is needed to adequately answer the research question.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression-free Survival at 12 Months Based Upon Clinical and Radiological Assessments Completed as Part of Routine Care | 12 months | 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. |
| Secondary | Number of Patients With Both Metastatic Breast Cancer and Hypothyroidism in All Screened Patients. | 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. | To quantitate the prevalence of hypothyroidism in metastatic breast cancer patients at a community oncology practice. |
| Secondary | Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire | Baseline, 3, 6, 9, and 12 months | 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. |
| Secondary | Measurement of Energy Level Across Time Using FACT-B Question. | Baseline, 3, 6, 9, 12 months | 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. |
| Secondary | Time to Achieve Euthyroid Hypothyroxinemia State | Number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value for each participant, assessed up to 12 months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progression-free Survival at 12 Months Based Upon Clinical and Radiological Assessments Completed as Part of Routine Care | 12 months | Last enrolled subject was only able to be followed for 9 months due to early termination of study. Subject not included in primary outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Both Metastatic Breast Cancer and Hypothyroidism in All Screened Patients. | 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. | Outcome was number of practice patients with both metastatic breast cancer and hypothyroidism. Of the 26 identified, 7 patients consented to enroll on the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire | Baseline, 3, 6, 9, and 12 months | Of the 7 subjects enrolled only 5 of the patients completed Quality of Life FACT-B questionnaires for all five timepoint. Two subjects did not complete the 12 months surveys due to death or premature study termination. | score on a scale | MEAN |
| SECONDARY | Measurement of Energy Level Across Time Using FACT-B Question. | Baseline, 3, 6, 9, 12 months | Of the 7 subjects enrolled only 5 of the patients completed Quality of Life FACT-B questionnaires for all five timepoint. Two subjects did not complete the 12 months surveys due to death or premature study termination. | score on a scale | MEAN |
| SECONDARY | Time to Achieve Euthyroid Hypothyroxinemia State | Number of days between initiation of triiodothyronine (T3) and documentation of first normal TSH value for each participant, assessed up to 12 months | days | MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progression-free Survival at 12 Months Based Upon Clinical and Radiological Assessments Completed as Part of Routine Care | Triiodothyronine (T3) | 4 | Participants | ||
| Number of Patients With Both Metastatic Breast Cancer and Hypothyroidism in All Screened Patients. | Triiodothyronine (T3) | 26 | Participants | ||
| Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire | Triiodothyronine (T3) | Baseline | 114 | Standard Deviation 24.56 | score on a scale |
| Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire | Triiodothyronine (T3) | At 3 months | 114 | Standard Deviation 16.80 | score on a scale |
| Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire | Triiodothyronine (T3) | At 6 months | 116 | Standard Deviation 20.71 | score on a scale |
| Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire | Triiodothyronine (T3) | At 9 months | 112 | Standard Deviation 26.92 | score on a scale |
| Measurement of Quality of Life Total Score Across Time Using Validated FACT-B Questionnaire | Triiodothyronine (T3) | At 12 months | 110 | Standard Deviation 23.68 | score on a scale |
| Measurement of Energy Level Across Time Using FACT-B Question. | Triiodothyronine (T3) | Baseline | 2.9 | Standard Deviation 1.07 | score on a scale |
| Measurement of Energy Level Across Time Using FACT-B Question. | Triiodothyronine (T3) | 3 months | 2.4 | Standard Deviation 1.3 | score on a scale |
| Measurement of Energy Level Across Time Using FACT-B Question. | Triiodothyronine (T3) | 6 months | 3.0 | Standard Deviation 1.16 | score on a scale |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Triiodothyronine (T3) | 7 | |
| Overall Study | COMPLETED | Triiodothyronine (T3) | 5 | |
| Overall Study | NOT COMPLETED | Triiodothyronine (T3) | 2 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Edema limbs | General disorders | Triiodothyronine (T3) | 1 | 7 | 1 |
| other | Nail changes | Skin and subcutaneous tissue disorders | Triiodothyronine (T3) | 2 | 7 | 2 |
| other | Memory Impairment | Nervous system disorders | Triiodothyronine (T3) | 3 | 7 | 3 |
| other | Hypertension | Vascular disorders | Triiodothyronine (T3) | 5 | 7 | 7 |
| other | Dyspepsia | Gastrointestinal disorders | Triiodothyronine (T3) | 2 | 7 | 2 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Triiodothyronine (T3) | 3 | 7 | 3 |
| other | Bronchial infection | Infections and infestations | Triiodothyronine (T3) | 1 | 7 | 1 |
| other | Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Triiodothyronine (T3) | 2 | 7 | 2 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Triiodothyronine (T3) | 3 | 7 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Triiodothyronine (T3) | 2 | 7 | 2 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triiodothyronine (T3) | 1 | 7 |
| Total, other adverse events | Triiodothyronine (T3) | 7 | 7 |
| Total, serious adverse events | Triiodothyronine (T3) | 2 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03787303
GET https://conductscience.org/api/trials/v1/NCT03787303/events?page=2