Trial · NCT02448420
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 | Progression-Free Survival at 6 months | From randomization date to date of first documentation of progression or death , whichever came first, assessed up to 6 months. | For cohorts A,B1 and B2: This was defined as the proportion of patients alive and without progression (according to RECIST v1.1 criteria), 6 months after randomization. |
| Primary | Progression-Free Survival (PFS)as Assessed by the Investigator [ Time Frame: From randomization date to date of first documentation of progression or death | From randomization date to date of first documentation of progression or death , whichever came first, assessed up to 4 years | For cohorts C: This will be defined as the proportion of patients alive and without progression (according to RECIST v1.1 criteria) |
| Secondary | Rate of Disease control rate (DCR) in treatment arms (A and B) | up to 5 years | Number of patients with objective response (complete or partial) or stable disease according to RECIST 1.1 criteria for at least 12 weeks. |
| Secondary | Rate of Overall tumour objective response rate (ORR) in treatment arms (A and B). | up to 5 years | Number of patients who achieve complete or partial response according to RECIST 1.1 criteria during treatment. |
| Secondary | Evaluation of time to progression (Cohorts A and B) | up to 5 years | Time between treatment start and disease progression |
| Secondary | Cardiac Safety profile in arms A and B: Percentage of Participants with cardiac adverse events | up to 5 years | Frequency of cardiac events of any grade, frequency of grade III-IV grade cardiac events according to NYHA classification. |
| Secondary | Overall Survival in treatment arms (Cohorts A and B). | up to 5 years | Measured as time between treatment start and all-cause death. |
| Secondary | Rate of Disease control rate (DCR) in both treatment arms (C1 and C2) | up to 4 years | Number of patients with objective response (complete or partial) or stable disease according to RECIST 1.1 criteria for at least 8 weeks. |
| Secondary | Rate of Overall tumour objective response rate (ORR) in treatment arms (C1 and C2). | up to 4 years | Number of patients who achieve complete or partial response according to RECIST 1.1 criteria during treatment. |
| Secondary | Median duration of response in both treatment arms (C1 and C2). | up to 4 years | Time of median duration of response according to RECIST 1.1 by treatment arm. |
| Secondary | Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy FACT-B to assess patient reported breast cancer specific health related quality of life (HRQOL) and general health status in both treatment arms (C1 and C2). | From the date of randomization up to 5 years | The FACT-B consists of the Functional Assessment of Cancer Therapy-General (FACT-G) (27-items) and a breast-specific module: a 10-item instrument designed to assess patient concernsrelating to BC. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Patients are asked to respond to a Likert scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. |
| Secondary | Change From Baseline Between Treatment Comparison in Euroqol-5D (EQ-5D) to assess patient reported breast cancer specific health related quality of life (HRQOL) and general health status in both treatment arms (C1 and C2). | From the date of randomization up to 5 years | The EuroQol EQ-5D is designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 5 levels of function (1=no problem, 2=slight problem, 3=moderate problem, 4=severe problem, and 5=unable/extreme). The scores on the 5 descriptors are summarized to create a single summary score. The EQ-5D also includes a visual analog scale (VAS), in which the patients self-rate their overall health status on a scale from 0 (worst imaginable) to 100 (best imaginable). |
| Secondary | Safety profile in all treatment arms: Percentage of Participants with Adverse Events | up to 5 years | Measurements used to assess the safety profile will include adverse events of any grade, grade 3 and 4 adverse events, withdrawals due to adverse events and dose reductions due to adverse events. CTCAE v.5.0 will be used to evaluate AE grade. |
| Secondary | To investigate biomarkers as predictors of response or resistance to the study treatment. | up to 5 years | Beyond PAM50 test, peripheral blood samples will be collected, and plasma extracted for circulating tumoral DNA (ctDNA) determination. |
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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