Trial · NCT01966471
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation | Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above. | The ITT lymph node positive population was a subpopulation of the randomized participant population including patients with positive lymph node. | Percent Probability | NUMBER |
| PRIMARY | Invasive Disease-Free Survival (IDFS) in the Overall Population | First participant randomized up to approximately 7.5 years | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Percent Probability | NUMBER |
| SECONDARY | IDFS Plus Second Primary Non-Breast Cancer | Baseline up to approximately 70 months | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Percent Probability | NUMBER |
| SECONDARY | Disease-Free Survival (DFS) | Baseline up to approximately 70 months | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Percent Probability | NUMBER |
| SECONDARY | Distant Recurrence-Free Interval (DRFI) | Baseline up to approximately 70 months | Percent Probability | NUMBER | |
| SECONDARY | Overall Survival (OS) | First participant randomized up to approximately 7.5 years | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Percent Probability | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events | From randomization to approximately 7.5 years | The safety population included all randomized participants who received at least one full or partial dose of any study treatment. 8 participants were randomized but did not receive any study treatment (5 in the Anthracycline, Trastuzumab, Pertuzumab, and Taxane \[AC-THP\] arm, 3 in the Anthracycline, Trastuzumab Emtansine and Pertuzumab \[AC-KP\] arm). 16 participants in the AC-THP and 13 participants in the AC-KP arm only received AC but no HER2 targeted therapy and were assigned to the AC-THP arm. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | First participant randomized up to approximately 7.5 years. | The safety population included all randomized participants who received at least one full or partial dose of any study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 | The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. The variation of the number of participants in the table reflects the number of participants with corresponding scores at the given visits and at baseline. | Units on a Scale | MEAN |
| SECONDARY | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 | The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. The variation of the number of participants in the table reflects the number of participants with corresponding scores at the given visits and at baseline. | Units on a Scale | MEAN |
| SECONDARY | Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment | From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above. | The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. This subset population includes only participants who received HER2-targeted therapy. | months | MEDIAN |
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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