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Trial · NCT06081244

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primarypathological complete remission (pCR)at surgeryno invasive tumour in breast and lymph nodes (ypT0/is and ypN0)
Primaryinvasive disease-free survival rate (iDFS),after 3 yearstime from date of first diagnosis to any invasive breast cancer event, death or secondary malignancy according to STEEP 2.0 criteria
SecondaryOverall survival (OS)6 yearstime from first diagnosis to death
Secondarydistant disease-free survival (dDFS)after 3 yearsdistant disease-free survival
Secondarydistant disease-free interval (dDFI)after 3 yearsdistant disease-free interval
Secondaryrecurrence-free survival (RFS)after 3 yearsrecurrence-free survival
Secondarylocal recurrence-free survival (LRFS)after 3 yearslocal recurrence-free survival
SecondaryBreast cancer free interval (BCFI)after 3 yearsBreast cancer free interval
SecondaryHealth-related Quality of Life: Quality of Life Questionnaire C30Baseline to end of cycle 2 (each cycle is 21 days)change in QLQ-C30-Score; min 0 - max 100 points; the higher the better quality of life
SecondaryHealth-related Quality of Life: Quality of Life Questionnaire BR45Baseline to end of cycle 2 (each cycle is 21 days)change in BR45-Score; min 0 - max 100 points; the higher points on functional scale the better the function; the higher points on symptom scale the higher the symptomatology.
SecondaryHealth-related Quality of Life: Quality of Life Questionnaire C30Baseline to end of cycle 4 (each cycle is 21 days)change in QLQ-C30-Score; min 0 - max 100 points; the higher the better quality of life
SecondaryHealth-related Quality of Life: Quality of Life Questionnaire BR45Baseline to end of cycle 4 (each cycle is 21 days)change in BR45-Score; min 0 - max 100 points; the higher points on functional scale the better the function; the higher points on symptom scale the higher the symptomatology.
SecondaryHealth-related QoL: EORTC QLQ-C30Baseline to end of cycle 6 (each cycle is 21 days)change in QLQ-C30-Score; min 0 - max 100 points; the higher the better quality of life
SecondaryHealth-related Quality of Life: Quality of Life Questionnaire BR45Baseline to end of cycle 6 (each cycle is 21 days)change in BR45-Score; min 0 - max 100 points; the higher points on functional scale the better the function; the higher points on symptom scale the higher the symptomatology.
SecondaryHealth-related QoL: EORTC QLQ-C30Baseline to timepoint before surgerychange in QLQ-C30-Score; min 0 - max 100 points; the higher the better quality of life
SecondaryHealth-related QoL: EORTC QLQ-BR45Baseline to timepoint before surgerychange in QLQ-BR45-Score
SecondaryHealth-related Quality of Life: Quality of Life Questionnaire C30Baseline to timepoint 1 year after surgerychange in QLQ-C30-Score; min 0 - max 100 points; the higher the better quality of life
SecondaryHealth-related Quality of Life: Quality of Life Questionnaire BR45Baseline to timepoint 1 year after surgerychange in BR45-Score; min 0 - max 100 points; the higher points on functional scale the better the function; the higher points on symptom scale the higher the symptomatology.
OtherOther pCR-definitionsat time of surgeryypT0/is, any ypN * ypT0, ypN0 * near pCR (ypT1a/is, any ypN)
Otherstromal tumour infiltrating lymphocytes (sTIL)at baseline and after 3 weeks of therapypercentage of sTIL

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.

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