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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy in routine clinical practice in China.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Inavolisib

    Drug

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

  • Palbociclib

    Drug

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

  • Fulvestrant

    Drug

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

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Inavolisib3 interventions

Trial outcomes

Primary outcomes

1

Real-world Progression-free Survival (rwPFS)

Time frame
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)

Secondary outcomes

1

Number of Participants With Adverse Events (AEs)

Time frame
Up to approximately 36 months
2

Real-world Time to Progression (rwTTP)

Time frame
From index date to first occurrence of PD (up to approximately 36 months)
3

Number of Participants With Real-world Tumor Response (rwTR) to the Treatment

Time frame
Up to approximately 36 months
4

Real-world Duration of Response (rwDoR)

Time frame
From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months)

Other outcomes

Sponsors and contacts

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