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
NCT ID: NCT07347600
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2026-01-21
2029-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Inavolisib
Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy will be observed for effectiveness and safety of inavolisib.
Inavolisib
Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Palbociclib
Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Fulvestrant
Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Interventions
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Inavolisib
Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Palbociclib
Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Fulvestrant
Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Reference Study ID Number: ML46361 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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ML46361
Identifier Type: -
Identifier Source: org_study_id
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