T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Krishnamurthy, Jairam
Eligibility: https://clinicaltrials.gov/ct2/show/study/NCT04457596?term=NCT04457596&draw=2&rank=1#eligibility
Summary
Primary Outcome Measures :
Modified invasive disease-free survival (iDFS) [ Time Frame: From randomization to one of the following events: invasive local, regional or distant recurrence, invasive contralateral breast cancer or death from any cause, assessed up to 10 years ]
A Kaplan-Meier method will be used to estimate the survival curves and a stratified log-rank test will be used to compare the invasive disease-free survival (iDFS) of the two arms. A stratified Cox model will be used to estimate the hazard ratio. If there appears to be clinically significant imbalances of baseline variables between the treatment arms, a secondary analysis of the primary endpoint will use stratified Cox model to compare the treatment effects that include the variables that are deemed imbalanced between the arms as adjusting variables. The randomization stratification variables will be the stratified variables in the model.
Secondary Outcome Measures :
Unmodified invasive disease-free survival (iDFS) [ Time Frame: Up to 10 years ]
Will be defined as the time from randomization to one of the following events: invasive local, regional or distant recurrence, invasive contralateral breast cancer secondary primary invasive cancer (other than basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix), or death from any cause, assessed up to 10 years. A Kaplan-Meier method will be used to estimate the survival curves and a stratified log-rank test will be used to compare the iDFS of the two arms. A stratified Cox model will be used to estimate the hazard ratio.
Other Outcome Measures:
Quality of life [ Time Frame: Up to 8 cycles of treatment (each cycle is 21 days) ]
Will be assessed by the Functional Assessment of Cancer Therapy (FACT)-Breast Cancer (B) Trial Outcome Index questionnaire. The mixed model will compare the cycle 9 day 1 and cycle 14 day 1 time points between randomized arms. In addition to a randomized arm covariate, the model will include a randomized arm-by-time interaction term and will use the planned cycle of assessment as the categorical time value. Unstructured covariance will initially be used, though alternative covariance structures will be investigated with the final covariance structure selected based on minimization of the Akaike information criterion. A contrast will be used to compare mean change from baseline at cycle 9 day 1 between arms. If the two-sided 95% confidence interval excludes a difference of 5 favoring the trastuzumab emtansine (T-DM1) + placebo arm, then non-inferiority will be concluded.
Quality of life [ Time Frame: Up to 13 cycles of treatment (each cycle is 21 days) ]
Will be assessed by the Functional Assessment of Cancer Therapy (FACT)-Breast Cancer (B) Trial Outcome Index questionnaire. The mixed model will compare the mean change from baseline at cycle 14 day 1 between arms. If the two-sided 95% confidence interval excludes a difference of 5 favoring the T-DM1 + placebo arm, then non-inferiority will be concluded at this time point.