Trial · NCT05501886
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Approximately 48 months | PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR) |
| Secondary | Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | From date of randomization to the date of death due to any cause, up to approximately 48 months | OS is defined as the length of time from randomization until the date of death from any cause method, where PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR) |
| Secondary | Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Up to approximately 48 months | Percentage of subjects who achieved an objective response according to RECIST v1.1 criteria (complete response \[CR\] or partial response \[PR\]) as assessed by BICR) |
| Secondary | Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Up to approximately 48 months | Time from the assessment of initial response (PR or better) to death or first documented disease progression as assessed by BICR, whichever occurs first |
| Secondary | Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Up to approximately 48 months | Time form randomization to the first assessment of PR or better as assessed by BICR, whichever comes first |
| Secondary | Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | Up to approximately 48 months | Percentage of subjects with CR, PR, or stable disease (SD) \>24 weeks as assessed by BICR |
| Secondary | Quality of Life (QOL)Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI) Questions in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | From baseline to 30 Day Safety Follow-up | The FACT-B TOI is an abbreviated (24-item) version of the full FACT-B which focuses only on the patient's Physical Well-being (PWB), Functional Well-being (FWB), and Breast Cancer Subscale (BCS) components using a 5-level scale, (Not at all, A little bit, Some-what, Quite a bit, Very much). |
| Secondary | Quality of Life (QOL) NCCN-FACT Breast Symptom Index -16 (NFBSI-16) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | From baseline to 30 Day Safety Follow-up | NCCN-FACT is derived from the FACT-B and only 4 additional items will be administered to enable optional scoring of the NFBSI subscales and total score using a 5-level scale (Not at all, A little bit, Some-what, Quite a bit, Very much). |
| Secondary | Patient-Reported Outcomes in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | From baseline to 30 Day Safety Follow-up | Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Form v2.0 - Physical Function 8c using a 5-level scale (Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do) |
| Secondary | EuroQol 5 in Patients with PIK3CA WT and PIK3CA MT Breast Cancer | From baseline to 30 Day Safety Follow-up | EuroQol 5 Dimension 5 Level (EQ-5D-5L) - This is a 5 question, self-administered visual analog scale (VAS) where patients use 0 (worst health) to 100 (best health) to indicate how they view their health. |
| Secondary | Adverse Events | Up to approximately 48 months | Safety and tolerability will be evaluated by review of type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05501886/registered