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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Inavolisib
  Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
• Препарат Palbociclib
  Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
• Препарат Fulvestrant
  Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

Первичные конечные точки

• Real-world Progression-free Survival (rwPFS) [Срок оценки: From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 months)]

Вторичные конечные точки (10)

• Number of Participants With Adverse Events (AEs) [Срок оценки: Up to approximately 36 months]
• Real-world Time to Progression (rwTTP) [Срок оценки: From index date to first occurrence of PD (up to approximately 36 months)]
• Number of Participants With Real-world Tumor Response (rwTR) to the Treatment [Срок оценки: Up to approximately 36 months]
• Real-world Duration of Response (rwDoR) [Срок оценки: From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months)]
• Real-world Time-to-treatment Discontinuation (rwTTD) [Срок оценки: From index date to inavolisib discontinuation, new anti-cancer therapy initiation or death from any cause (up to approximately 36 months)]
• Real-world Time to Next Treatment (rwTTNT) [Срок оценки: From index date to new anti-cancer therapy (up to approximately 36 months)]
• Real-world Time to Chemotherapy (rwTTC) [Срок оценки: From index date to date of chemotherapy initiation (up to approximately 36 months)]
• Treatment Duration of Inavolisib [Срок оценки: Up to approximately 36 months]
• Total Dose of Inavolisib Received [Срок оценки: Up to approximately 36 months]
• Number of Participants Who Experience Dose Modification, Including Missing Doses, Dose Interruption, Dose Reduction, or Early Discontinuation [Срок оценки: Up to approximately 36 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 28 центров

• The First Affiliated Hospital of Xiamen University — Xiamen
• Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditio — Lanzhou
• The First Hospital of Jilin University — Changchun
• Wenzhou Medical University Affiliated Second Hospital — Wenzhou
• Peking University First Hospital — Пекин
• Peking University Third Hospital — Пекин
• Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Чэнду
• Chongqing Cancer Hospital — Чунцин
• … и ещё 20 центров

Идентификаторы

NCT: NCT07347600 · ML46361

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗