An observational study in Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by Novartis Pharmaceuticals · Observational
This was a retrospective observational study of patients with advanced breast cancer (BC). This non-interventional study was conducted using discrete structured data and medical record abstraction, if needed, from patients treated at Texas Oncology, the designated research organization and a community oncology practice. The first date of a new diagnosis of advanced BC (de novo or progressed to advanced BC) defined the study index date. To allow for an adequate potential duration of follow-up (retrospectively observed) after the index date over which PIK3CA testing and treatment patterns was observed, a minimum follow-up opportunity of 6 months after the diagnosis of advanced BC at the time of data pull and/or abstraction was required.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 1,093 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
This was a retrospective, noninterventional cohort study
Not ever enrolled in the following interventional clinical trials evaluating PI3K inhibitors:
Exclusion Criteria:
None
Number of patients with PIK3CA mutations
Time frame: Up to approximately 6 years
Time from first BC diagnosis to first PIK3CA evaluation
Time frame: Up to approximately 6 years
Time from advanced BC diagnosis to first PIK3CA evaluation
Time frame: Up to approximately 6 years
Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation
Time frame: Up to approximately 6 years
Number of tests for patients with CDK4/6 inhibitor treatment
Time frame: Up to approximately 6 years
Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation
Time frame: Up to approximately 6 years
Year of (first, where applicable) PIK3CA evaluation
Time frame: Up to approximately 6 years
Result of PIK3CA evaluation (negative, positive, unknown)
Time frame: Up to approximately 6 years
Type of biopsy
Time frame: Up to approximately 6 years
Type of tissue sample, for patients who had tissue biopsy
Time frame: Up to approximately 6 years
Source of tissue sample, for patients who had tissue biopsy
Time frame: Up to approximately 6 years
Analytical method used for PIK3CA evaluation
Time frame: Up to approximately 6 years
Age at advanced breast cancer diagnosis
Time frame: Up to approximately 6 years
Stage when patients were diagnosed with BC
Time frame: Up to approximately 6 years
Number of patients with known metastatic sites
Time frame: Up to approximately 6 years
Performance as assessed by Karnofsky Performace Scale
The Karnofsky Performance Scale is a measure of functional impairment.
Time frame: Up to approximately 6 years
Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Time frame: Up to approximately 6 years
Height
Time frame: Up to approximately 6 years
Weight
Time frame: Up to approximately 6 years
Body mass index (BMI)
Time frame: Up to approximately 6 years
Number of patients per stage of cancer
Time frame: Up to approximately 6 years
Number of patients per line of treatment
Time frame: Up to approximately 6 years
Time from advanced diagnosis to initiation of lines of treatment
Time frame: Up to approximately 6 years
Number of patients per systemic therapy
Time frame: Up to approximately 6 years
Number of patients per treatment sequence
Time frame: Up to approximately 6 years
Number of patients per supportive treatment
Time frame: Up to approximately 6 years
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals