Trial · NCT05023967
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of occurrence of dose limiting toxicity | Up to 4-6 weeks | Defined as a hypoglycemic event requiring permanent discontinuation of study treatment or any grade 3 or greater adverse event possibly, probably, or definitely related to the study drug. |
| Primary | Change in pre-post treatment Ki67 labeling index in invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) (in the absence of IBC) | Baseline up to 4-6 weeks | Generalized linear models will be used to assess differences between treatment arms for Ki67. Log transformation will be considered to obtain normal distribution of residuals. Will also evaluate the need to adjust for baseline characteristics and significant confounders (such as body mass index \[BMI\] and HER2 status). |
| Primary | Difference in post-treatment adjacent DCIS (in the presence of IBC), if present, or intraepithelial neoplasia Ki67 between arms | Post-treatment (4-6 weeks) | Generalized linear models will be used to assess differences between treatment arms for Ki67. Log transformation will be considered to obtain normal distribution of residuals. Will also evaluate the need to adjust for baseline characteristics and significant confounders (such as BMI and HER2 status). |
| Secondary | Change in circulating biomarkers | Baseline up to 4-6 weeks | Will include Homeostatic model assessment index, highly sensitive C-reactive protein, C-peptide, IGF-I, IGFBP-1, IGFBP-3, free IGF-I, Hb1Ac, lipid profile, leptin and adiponectin. Will present full distributions and median values of circulating biomarkers, Ki67, at baseline, after treatment, and of changes and percentage changes (with interquartile ranges) of all continuous variables, by arms. Analysis of covariance (ANCOVA) models will evaluate the associations of post values (after treatment) and changes from baseline by study arms adjusting for baseline values, explanatory variables and possible confounders (such as age and BMI). Normal distribution of residuals from full models will be checked and, if needed, a transformation will be considered. |
| Secondary | Change of CIP2A-PP2A-GSK3beta-MCL-1 axis in cancer tissue | Baseline up to 4-6 weeks | Will present full distributions and median values of circulating biomarkers, Ki67, at baseline, after treatment, and of changes and percentage changes (with interquartile ranges) of all continuous variables, by arms. ANCOVA models will evaluate the associations of post values (after treatment) and changes from baseline by study arms adjusting for baseline values, explanatory variables and possible confounders (such as age and BMI). Normal distribution of residuals from full models will be checked and, if needed, a transformation will be considered. |
| Secondary | Change of Ki67 in cancer tissue | Baseline up to 4-6 weeks | Will depend upon next generation sequencing mutational profile obtained in post-treatment surgical specimens. Will present full distributions and median values of circulating biomarkers, Ki67, at baseline, after treatment, and of changes and percentage changes (with interquartile ranges) of all continuous variables, by arms. ANCOVA models will evaluate the associations of post values (after treatment) and changes from baseline by study arms adjusting for baseline values, explanatory variables and possible confounders (such as age and BMI). Normal distribution of residuals from full models will be checked and, if needed, a transformation will be considered. |
| Secondary | Difference of M30 | Post-treatment | Will be assessed between arms. Will be assessed using IHC. |
| Secondary | Difference of phosphorylated S6 | Post-treatment | Will be assessed between arms. Will be assessed using IHC. |
| Secondary | Physiological distress | Up to 4-6 weeks | Will be correlated with response biomarkers. |
| Secondary | Eating habits | Up to 4-6 weeks | Will be correlated with response biomarkers. |
| Secondary | Tobacco | Up to 4-6 weeks | Will be correlated with response biomarkers. |
| Secondary | Alcohol consumption | Up to 4-6 weeks | Will be correlated with response biomarkers. |
| Secondary | Incidence of adverse events | Up to 4-6 weeks | Evaluated according to the Common Terminology Criteria for Adverse Events version 5.0. |
| Secondary | Difference of the area under the curve of glucose levels | Up to 4-6 weeks | Will be assessed between arms. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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