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Advancements in Cancer Research: Progress and Promise

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Larvol Clinic
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Primary Outcome Measures :

  1. Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years [ Time Frame: At 3 years ]

  2. iBCFS is defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or contralateral invasive BC. iBCFS will be assessed using STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator.

  3. The iBCFS rate at 3 years will be assessed

Secondary Outcome Measures :

  1. Invasive Disease-Free Survival (iDFS) [ Time Frame: Up to approximately 6 years ]

  2. iDFS is defined as the time from the date of first dose of study treatment to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed using STEEP 2.0 as assessed by the investigator.

  3. Distant Relapse-Free Survival (DRFS) [ Time Frame: Up to approximately 6 years ]

  4. Distant Relapse Free Survival (DRFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site or death (any cause). DRFS will be assessed using STEEP 2.0 as assessed by the investigator

  5. Recurrence-Free Interval (RFI) [ Time Frame: Up to approximately 6 years ]

  6. RFI is defined as the time from date of first dose to date of first event of invasive recurrence in the ipsilateral breast or locoregionally, at a distant site, or death from breast cancer. RFI will be assessed using STEEP 2.0 as per investigator assessment

  7. Relative dose intensity (RDI) of ribociclib [ Time Frame: Up to 3 years ]

  8. RDI is defined as the ratio of the dose intensity delivered to the planned dose intensity.

  9. Overall Survival (OS) [ Time Frame: Up to approximately 6 years ]

  10. OS is defined as time from the start of study treatment to date of death due to any cause.

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