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Locally Advanced Breast CancerreaINAVONCT07347600

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

An observational study of Locally Advanced Breast Cancer and Metastatic Breast Cancer, run by Hoffmann-La Roche at 32 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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-)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inavolisib, Palbociclib and Fulvestrant
How many people
500 participants
Where
32 sitesChina
Study dates
21 Jan 2026to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: ML46361 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

32 sites in 1 country

China32 sites, 32 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, 610072

    Recruiting

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016

    Recruiting

  • Chongqing Cancer Hospital

    Chongqing, 400030

    Recruiting

  • Sun Yat-sen Memorial Hospital

    Guangzhou, 510120

    Recruiting

  • Zhujiang Hospital, Southern Medical University

    Guangzhou, 510280

    Recruiting

  • Guangdong Provincial Traditional Chinese Medicine Hospital

    Guangzhou, 510335

    Recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, 550002

    Recruiting

  • Hainan Provincial Peoples Hospital

    Haikou, 570311

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

    Recruiting

  • Shandong Provincial Hospital

    Jinan, 250021

    Recruiting

  • Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)

    Lanzhou, Gansu, 730050

    Recruiting

  • Luoyang Central Hospital

    Luoyang, 471000

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, 330006

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, 210029

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

    Recruiting

  • Liaoning cancer Hospital & Institute

    Shenyang, 110042

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, 030013

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, 317000

    Recruiting

  • Weifang People's Hospital

    Weifang, 261041

    Recruiting

  • Wenzhou Medical University Affiliated Second Hospital

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, 430079

    Recruiting

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Recruiting

  • Subei People's Hospital of Jiangsu province

    Yangzhou, 225001

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, 450008

    Recruiting

  • Zhongshan City People's Hospital

    Zhongshan, 528403

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Inavolisib, Palbociclib, Fulvestrant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InavolisibDrug

    Also called GDC-0077

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

  • PalbociclibDrug

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

  • FulvestrantDrug

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

Study groups in NCT07347600
Study groupRoleWhat they receive
InavolisibParticipants 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.
Receives: Drug: Inavolisib; Drug: Palbociclib; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Real-world Progression-free Survival (rwPFS)

    Measured: 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 (10)

  1. Number of Participants With Adverse Events (AEs)

    Measured: Up to approximately 36 months

  2. Real-world Time to Progression (rwTTP)

    Measured: 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

    Measured: Up to approximately 36 months

  4. Real-world Duration of Response (rwDoR)

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

  5. Real-world Time-to-treatment Discontinuation (rwTTD)

    Measured: From index date to inavolisib discontinuation, new anti-cancer therapy initiation or death from any cause (up to approximately 36 months)

  6. Real-world Time to Next Treatment (rwTTNT)

    Measured: From index date to new anti-cancer therapy (up to approximately 36 months)

  7. Real-world Time to Chemotherapy (rwTTC)

    Measured: From index date to date of chemotherapy initiation (up to approximately 36 months)

  8. Treatment Duration of Inavolisib

    Measured: Up to approximately 36 months

  9. Total Dose of Inavolisib Received

    Measured: Up to approximately 36 months

  10. Number of Participants Who Experience Dose Modification, Including Missing Doses, Dose Interruption, Dose Reduction, or Early Discontinuation

    Measured: Up to approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start21 Jan 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07347600
Sponsor's protocol ID
ML46361
Acronym
reaINAVO
Status last verified
Nov 2026
First submitted
9 Jan 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Locally Advanced Breast Cancer and Metastatic Breast Cancer, run by Hoffmann-La Roche at 32 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: ML46361 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07347600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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