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NCT Number: NCT05982886

Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who met the following criteria were eligible for abstraction:
  • Newly diagnosed advanced BC between 01 January 2015, and 30 June 2020
  • Evaluated for a PIK3CA mutation and identified PIK3CA gene status
  • No evidence of active other malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of advanced BC
  • At least 18 years of age at the time of first diagnosis of BC
  • Patients may be alive or deceased at the time of abstraction
  • Not ever enrolled in the following interventional clinical trials evaluating PI3K inhibitors:
  • SOLAR-1 trial (NCT0243731) evaluating alpelisib (BYL719)
  • BELLE-2 or BELLE-3 trial (NCT01610284, NCT01633060) evaluating buparlisib (BKM120)
  • SANDPIPER trial (NCT02340221) evaluating taselisib (GDC-0032)

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  1. Number of patients with PIK3CA mutations

    Time frame: Up to approximately 6 years

  2. Time from first BC diagnosis to first PIK3CA evaluation

    Time frame: Up to approximately 6 years

  3. Time from advanced BC diagnosis to first PIK3CA evaluation

    Time frame: Up to approximately 6 years

  4. Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation

    Time frame: Up to approximately 6 years

  5. Number of tests for patients with CDK4/6 inhibitor treatment

    Time frame: Up to approximately 6 years

  6. Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation

    Time frame: Up to approximately 6 years

  7. Year of (first, where applicable) PIK3CA evaluation

    Time frame: Up to approximately 6 years

  8. Result of PIK3CA evaluation (negative, positive, unknown)

    Time frame: Up to approximately 6 years

  9. Type of biopsy

    Time frame: Up to approximately 6 years

  10. Type of tissue sample, for patients who had tissue biopsy

    Time frame: Up to approximately 6 years

  11. Source of tissue sample, for patients who had tissue biopsy

    Time frame: Up to approximately 6 years

  12. Analytical method used for PIK3CA evaluation

    Time frame: Up to approximately 6 years

Secondary outcomes

  1. Age at advanced breast cancer diagnosis

    Time frame: Up to approximately 6 years

  2. Stage when patients were diagnosed with BC

    Time frame: Up to approximately 6 years

  3. Number of patients with known metastatic sites

    Time frame: Up to approximately 6 years

  4. Performance as assessed by Karnofsky Performace Scale

    Time frame: Up to approximately 6 years

    The Karnofsky Performance Scale is a measure of functional impairment.

  5. Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale

    Time frame: Up to approximately 6 years

    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.

  6. Height

    Time frame: Up to approximately 6 years

  7. Weight

    Time frame: Up to approximately 6 years

  8. Body mass index (BMI)

    Time frame: Up to approximately 6 years

  9. Number of patients per stage of cancer

    Time frame: Up to approximately 6 years

  10. Number of patients per line of treatment

    Time frame: Up to approximately 6 years

  11. Time from advanced diagnosis to initiation of lines of treatment

    Time frame: Up to approximately 6 years

  12. Number of patients per systemic therapy

    Time frame: Up to approximately 6 years

  13. Number of patients per treatment sequence

    Time frame: Up to approximately 6 years

  14. Number of patients per supportive treatment

    Time frame: Up to approximately 6 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2023
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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