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)

June 11, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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
      • Shenyang, China, 110042
        • Recruiting
        • Liaoning Cancer Hospital & Institute
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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