[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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Study’s contact

Call center

+41613241111

Email address

novartis.email@novartis.com

Condition

Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation

Treatment type

Observational

Investigational product

Alpelisib

Sponsor

Novartis

ClinicalTrials.gov identifier

NCT04967248

Study number

CBYL719C2404

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About the study

This is a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Signed informed consent from the patient or a legally acceptable representative, obtained before any study-related activities are undertaken
  2. Patients diagnosed with HR+, HER2
  3. locally advanced or metastatic breast cancer with a PIK3CA mutation
  4. Patients who have disease progression following endocrine therapy as monotherapy
  5. Patients must be postmenopausal women, or men, ≥18 years of age
  6. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant
Exclusion criteria

  1. Use of alpelisib prior to signing the informed consent form for this study
  2. Participation in an interventional study within 30 days prior to the initiation of alpelisib

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site