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A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

Recruitingn/aAges 18 Years - anyAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy * Participants must receive the treatment of inavolisib for the first time * PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\] by testing of blood or tumor tissue prior to the initiation of inavolisib Exclusion Criteria: * Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant * Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling * At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study
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What it tests

  • Inavolisib
  • Palbociclib
  • Fulvestrant
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Where

32 sites
The First Affiliated Hospital of Xiamen University
Xiamen, China
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
Lanzhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
The First Hospital of Jilin University
Changchun, China
Wenzhou Medical University Affiliated Second Hospital
Wenzhou, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, China

โ€ฆand 24 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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