Breast CancerPhase 2NCT07618390

A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

A Phase 2 study testing Inavolisib + Ribociclib + Fulvestrant in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This is a prospective, multicenter, open-label, single-arm phase II investigator-initiated study designed to evaluate the efficacy and safety of inavolisib in combination with ribociclib and fulvestrant as first-line treatment in Chinese patients with PIK3CA-mutant, hormone receptor-positive (HR+), HER2-negative… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Inavolisib + Ribociclib + Fulvestrant
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: No sites listed yet
Study dates: Jun 2026to Dec 2028
Phase: Phase 2
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must meet all of the following criteria:
Signed informed consent form (ICF).
Female, aged ≥18 years at the time of signing the ICF.
Must meet one of the following definitions of postmenopausal status:
Age ≥60 years; OR
Age <60 years with amenorrhea for ≥12 consecutive months in the absence of oral contraceptives, hormone replacement therapy, or gonadotropin-releasing hormone (GnRH) agonists/antagonists, and with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range per local laboratory assessment; OR

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Documented bilateral oophorectomy performed ≥14 days before Cycle 1 Day 1 (first treatment), with recovery to baseline status.
For premenopausal or perimenopausal women (i.e., those not meeting postmenopausal criteria), the following is also required:
Ongoing treatment with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin or leuprorelin) initiated at least 2 weeks before Cycle 1 Day 1 and continued throughout study treatment.
Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and not amenable to curative surgery or radiotherapy.
Estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor per ASCO/CAP guidelines, defined as ≥1% of tumor cells showing positive staining on the most recent tumor biopsy.
HER2-negative per ASCO/CAP guidelines, defined as: HER2 IHC score 0 or 1+, or IHC 2+ with negative ISH (FISH/CISH/SISH), or HER2/CEP17 ratio <2.0 on the most recent biopsy, based on local laboratory assessment.
Biomarker eligibility: PIK3CA mutation status must be determined by PCR or NGS testing of blood or tumor tissue at a local or regional laboratory. Blood samples should represent metastatic disease and be collected after the most recent anticancer therapy; tumor tissue should preferably be from metastatic lesions.
Disease progression during or within 12 months after completion of adjuvant endocrine therapy (aromatase inhibitor or tamoxifen). If CDK4/6 inhibitor was used in neoadjuvant/adjuvant setting, time from completion of CDK4/6 inhibitor to progression must be >12 months.
At least one measurable lesion per RECIST v1.1. Patients with only bone metastases are not eligible, even if lesions are measurable.
Women of childbearing potential must agree to abstinence or use effective non-hormonal contraception (failure rate <1% per year) during treatment and for specified post-treatment periods (depending on study drug), and must not donate oocytes.
ECOG performance status 0-1.
Life expectancy >6 months.
Adequate hematologic and organ function within 14 days prior to treatment initiation, including:
ANC ≥1500/μL Hemoglobin ≥9 g/dL Platelets ≥100,000/μL Fasting glucose <126 mg/dL and HbA1c <6.0% Total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome) Albumin ≥2.5 g/dL AST/ALT ≤2.5×ULN (≤5×ULN with liver metastases) ALP ≤2.5×ULN (≤5×ULN with liver/bone metastases) Creatinine clearance ≥60 mL/min (Cockcroft-Gault) INR <1.5×ULN and aPTT <1.5×ULN (with specified exceptions for anticoagulation)
Ability and willingness to comply with study procedures as judged by the investigator.

Who cannot join

Metaplastic breast carcinoma.
Any history of leptomeningeal disease or carcinomatous meningitis.
Prior systemic therapy for metastatic breast cancer (mBC).
Prior treatment with fulvestrant or other selective estrogen receptor degraders (SERDs), except neoadjuvant use ≤6 months.
Prior exposure to PI3K, AKT, or mTOR inhibitors, or any drugs targeting the PI3K-AKT-mTOR pathway.
Requirement for cytotoxic chemotherapy at study entry (e.g., visceral crisis as per local guidelines).

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Type 2 diabetes requiring ongoing systemic treatment at enrollment, or history of type 1 diabetes.
Inability or unwillingness to take oral medication or receive intramuscular injections.
Malabsorption syndrome or any condition affecting gastrointestinal absorption.
Untreated or active CNS metastases (progressive disease or requiring anticonvulsants or corticosteroids for symptom control).
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage more frequently than every 2 weeks.
Severe infection requiring intravenous antibiotics within 7 days prior to enrollment.
Any concurrent ocular or intraocular disease requiring intervention during the study to prevent or treat potential vision loss.
Active inflammatory or infectious ocular disease, or history of autoimmune/idiopathic uveitis.
Requirement for daily supplemental oxygen therapy.
Symptomatic active pulmonary disease, including pneumonia.
Active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), or current immunosuppressive treatment for such disease.
Any active intestinal inflammation, including diverticulitis.
Symptomatic hypercalcemia requiring ongoing bisphosphonate or denosmab therapy.
Clinically significant active liver disease, including severe hepatic impairment (Child-Pugh B/C), viral hepatitis, cirrhosis, or current alcohol abuse.
Known HIV infection.
Any severe, uncontrolled systemic disease (e.g., significant cardiopulmonary, metabolic, or infectious disease) that may affect study safety or interpretation.
Anticancer therapy within 2 weeks prior to first dose.
Investigational drug use within 4 weeks prior to first dose.
Prior irradiation of ≥25% of bone marrow, or prior stem cell/bone marrow transplantation.
Unresolved toxicities from prior therapy (except alopecia, hot flashes, or peripheral neuropathy ≤Grade 2).
Other malignancy within 5 years prior to screening, except low-risk cancers (e.g., treated cervical carcinoma in situ, non-melanoma skin cancer, or stage I uterine cancer).
Significant cardiovascular disease, including:
Stroke or TIA within 6 months
Myocardial infarction within 6 months
NYHA class III-IV heart failure or clinically significant CHF
Uncontrolled arrhythmias or ventricular arrhythmias requiring treatment
Clinically significant coronary artery disease or unstable angina
QTc prolongation (>470 ms using Fridericia formula) or history of long/short QT syndrome, Brugada syndrome, or torsades de pointes
Clinically significant ECG abnormalities (e.g., complete LBBB, high-grade AV block)
Evidence of prior myocardial infarction on ECG
Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia).
Chronic use of ≥10 mg/day prednisone equivalent or other systemic corticosteroids/immunosuppressants.
Known hypersensitivity to inavolisib, ribociclib, or fulvestrant components.
Use of strong CYP3A4 inhibitors or inducers within 1 week or 5 half-lives (whichever is longer) prior to treatment initiation.
Pregnancy, breastfeeding, or planning pregnancy during study or within defined post-treatment periods (inavolisib 7 days, ribociclib 21 days, fulvestrant up to 2 years).
Major surgery or significant trauma within 28 days prior to Cycle 1 Day 1, or expected need for major surgery during the study.
Minor surgery within 7 days prior to first dose without adequate recovery (including proper wound healing).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jianli Zhao contact

15920589334

zhaojianii1988@126.com

About this study

The study consists of a screening period of up to 28 days, a treatment period, and a post-treatment follow-up period.

PIK3CA mutation status must be determined in blood or tumor tissue using polymerase chain reaction (PCR)-based assays or next-generation sequencing (NGS) performed in a local clinical laboratory. Patients with locally confirmed PIK3CA mutations who meet all eligibility criteria will be enrolled and receive study treatment with inavolisib, ribociclib, and fulvestrant. Details of the treatment regimen are provided in the Study Treatment section. Study treatment will continue until radiologically confirmed disease progression as determined by the investigator, unacceptable toxicity, withdrawal of informed consent, or study termination, whichever occurs first.

Patients must have measurable disease according to RECIST v1.1. Patients with bone-only metastases are not eligible, even if the lesions are considered measurable. Locally advanced disease must be unsuitable for surgical resection or other local treatment with curative intent.

Conditions: Breast Cancer
Being tested: Inavolisib + Ribociclib + Fulvestrant
Keywords: breast cancer, PIK3CA-mutant, HER2-negative, HR-positive
Medical subject headings: Breast Neoplasms

What participants receive

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

Inavolisib + Ribociclib + FulvestrantDrug
A total of 160 Chinese patients who meet the eligibility criteria and are confirmed to have PIK3CA-mutant breast cancer will receive the following treatment regimen:
- Inavolisib: 9 mg tablet, administered orally once daily (PO QD), on Days 1-28 of each 28-day cycle, starting from Cycle 1 Day 1;
- Ribociclib: 600 mg capsule or tablet, administered orally once daily (PO QD), on Days 1-21 of each 28-day cycle, starting from Cycle 1 Day 1;
- Fulvestrant: 500 mg administered by intramuscular injection (IM) on Days 1 and 15 of Cycle 1, and thereafter on Day 1 of each subsequent 28-day cycle (approximately every 4 weeks).

Study groups in NCT07618390
Study group	Role	What they receive
Inavolisib + Ribociclib + Fulvestrant	Experimental	Not described Receives: Drug: Inavolisib + Ribociclib + Fulvestrant

What is being measured

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

Progression-free survival (PFS)
Progression-free survival (PFS), defined as the time from initiation of the first study treatment to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first, as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months

Secondary outcomes (3)

Objective Response Rate (ORR)
Objective response rate (ORR), defined as the proportion of patients who achieve a confirmed complete response (CR) and/or partial response (PR) on at least two consecutive assessments performed at least 4 weeks apart, as assessed by the investigator according to RECIST v1.1.
Measured: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months
Duration of Response (DOR)
Duration of response (DOR), defined as the time from the first documented CR or PR to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first, as assessed by the investigator according to RECIST v1.1.
Measured: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months
Clinical Benefit Rate (CBR)
Clinical benefit rate (CBR), defined as the proportion of patients who achieve CR, PR, and/or stable disease (SD) lasting for at least 24 weeks, as assessed by the investigator according to RECIST v1.1.
Measured: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months

Timeline

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

Jun 2026Dec 2028

First posted1 Jun 2026
Study startJun 2026 (estimated)
Primary completionDec 2028 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07618390
Sponsor's protocol ID: SYSKY-2026-061-01
Status last verified: May 2026
First submitted: 25 May 2026
Last updated: 1 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Jianli Zhao

15920589334

zhaojianii1988@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.
ClinicalTrials.gov ID: NCT07618390
Acronym / sponsor ID: SYSKY-2026-061-01
Conditions: Breast Cancer
Keywords: breast cancer, PIK3CA-mutant, HER2-negative, HR-positive
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 160 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Collaborators: Hoffmann-La Roche, Novartis
Study start: Jun 2026 (estimated)
Primary completion: Dec 2028 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 1 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study consists of a screening period of up to 28 days, a treatment period, and a post-treatment follow-up period.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Inavolisib + Ribociclib + Fulvestrant	Experimental	Drug: Inavolisib + Ribociclib + Fulvestrant

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Patients must meet all of the following criteria:
For premenopausal or perimenopausal women (i.e., those not meeting postmenopausal criteria), the following is also required:
ANC ≥1500/μL Hemoglobin ≥9 g/dL Platelets ≥100,000/μL Fasting glucose <126 mg/dL and HbA1c <6.0% Total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome) Albumin ≥2.5 g/dL AST/ALT ≤2.5×ULN (≤5×ULN with liver metastases) ALP ≤2.5×ULN (≤5×ULN with liver/bone metastases) Creatinine clearance ≥60 mL/min (Cockcroft-Gault) INR <1.5×ULN and aPTT <1.5×ULN (with specified exceptions for anticoagulation)

Key exclusion criteria (43 listed)

Metaplastic breast carcinoma.
Any history of leptomeningeal disease or carcinomatous meningitis.
Prior systemic therapy for metastatic breast cancer (mBC).
Prior treatment with fulvestrant or other selective estrogen receptor degraders (SERDs), except neoadjuvant use ≤6 months.
Prior exposure to PI3K, AKT, or mTOR inhibitors, or any drugs targeting the PI3K-AKT-mTOR pathway.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inavolisib + Ribociclib + FulvestrantA total of 160 Chinese patients who meet the eligibility criteria and are confirmed to have PIK3CA-mutant breast cancer will receive the following treatment regimen: * Inavolisib: 9 mg tablet, administered orally once daily (PO QD), on Days 1-28 of each 28-day cycle, starting from Cycle 1 Day 1; * Ribociclib: 600 mg capsule or tablet, administered orally once daily (PO QD), on Days 1-21 of each 28-day cycle, starting from Cycle 1 Day 1; * Fulvestrant: 500 mg administered by intramuscular injection (IM) on Days 1 and 15 of Cycle 1, and thereafter on Day 1 of each subsequent 28-day cycle (approximately every 4 weeks).	Drug	Inavolisib + Ribociclib + Fulvestrant

Primary outcome

Progression-free survival (PFS)
Time frame: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months
Progression-free survival (PFS), defined as the time from initiation of the first study treatment to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first, as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

3 secondary outcomes

Objective Response Rate (ORR)
Time frame: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months
Duration of Response (DOR)
Time frame: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months
Clinical Benefit Rate (CBR)
Time frame: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jianli Zhao contact

15920589334

zhaojianii1988@126.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inavolisib + Ribociclib + Fulvestrant in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

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 21 inclusion and 43 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: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jianli Zhao (15920589334, zhaojianii1988@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From the date of first study treatment until documented disease progression or death from any cause, whichever occurs first, assessed up to 33 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 NCT07618390.

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 1 Jun 2026.