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 (reaINAVO)

May 14, 2026 updated by: Hoffmann-La Roche

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
      • Chongqing, China, 400030
        • Recruiting
        • Chongqing Cancer Hospital
      • Guangzhou, China, 510280
        • Recruiting
        • Zhujiang Hospital, Southern Medical University
      • Guiyang, China, 550002
        • Recruiting
        • Guizhou Provincial People's Hospital
      • Haikou, China, 570311
        • Recruiting
        • Hainan Provincial Peoples Hospital
      • Harbin, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
      • Hefei, China, 230022
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
      • Jinan, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
      • Nanchang, China, 330006
        • Recruiting
        • Jiangxi Cancer Hospital
      • Nanjing, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
      • Taiyuan, China, 030013
        • Recruiting
        • Shanxi Provincial Cancer Hospital
      • Taizhou, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
      • Weifang, China, 261041
        • Recruiting
        • Weifang People's Hospital
      • Wuhan, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
      • Xi'an, China
        • Recruiting
        • The First Affiliated Hospital of Xian Jiao Tong University
      • Yangzhou, China, 225001
        • Recruiting
        • Subei People's Hospital of Jiangsu province
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • Wenzhou Medical University Affiliated Second Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Inavolisib
Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Other Names:
  • GDC-0077
Drug: Palbociclib
Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Drug: Fulvestrant
Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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 Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 36 months
Up to approximately 36 months
Real-world Time to Progression (rwTTP)
Time Frame: From index date to first occurrence of PD (up to approximately 36 months)
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
Time Frame: Up to approximately 36 months
Up to approximately 36 months
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)
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)
Time Frame: From index date to inavolisib discontinuation, new anti-cancer therapy initiation or death from any cause (up to approximately 36 months)
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)
Time Frame: From index date to new anti-cancer therapy (up to approximately 36 months)
From index date to new anti-cancer therapy (up to approximately 36 months)
Real-world Time to Chemotherapy (rwTTC)
Time Frame: From index date to date of chemotherapy initiation (up to approximately 36 months)
From index date to date of chemotherapy initiation (up to approximately 36 months)
Treatment Duration of Inavolisib
Time Frame: Up to approximately 36 months
Up to approximately 36 months
Total Dose of Inavolisib Received
Time Frame: Up to approximately 36 months
Up to approximately 36 months
Number of Participants Who Experience Dose Modification, Including Missing Doses, Dose Interruption, Dose Reduction, or Early Discontinuation
Time Frame: Up to approximately 36 months
Up to approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

September 9, 2029

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML46361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Breast Cancer

Clinical Trials on Inavolisib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe