Breast CancerPhase 2optINAVONCT07368998
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
A Phase 2 study testing Inavolisib and Fulvestrant in people with Breast Cancer, run by Hoffmann-La Roche at 34 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Inavolisib and 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
- 80 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 18 Feb 2026to 31 Oct 2031
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
- Confirmation of biomarker eligibility: presence of >= 1 study-eligible PIK3CA mutation
- Life expectancy of > 6 months
- Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes
Who cannot join
- Metaplastic breast cancer
- Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
- Requirement for daily supplemental oxygen
- Symptomatic active lung disease, including pneumonitis
Trial locations and contacts
34 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
34 sites in 8 countries
Argentina6 sites, 6 recruiting
- Recruiting
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE
- Recruiting
Hospital Privado - Centro Medico de Córdoba
Córdoba, 5016
- Recruiting
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE
- Recruiting
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, S2000KPG
- Recruiting
Hospital Provincial del Centenario
Rosario, S2002KDS
- Recruiting
Centro Oncológico de Excelencia
San Juan, J5402BGA
United States4 sites, 4 recruiting
- Recruiting
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816
- Recruiting
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
- Recruiting
HCA Midwest Division
Kansas City, Missouri, 64132
- Recruiting
Los Angeles Cancer Network
Los Angeles, California, 90017-4803
Australia4 sites, 4 recruiting
- Recruiting
Bendigo Cancer Centre
Bendigo, Victoria, 3550
- Recruiting
Blacktown Hospital
Blacktown, New South Wales, NSW 2148
- Recruiting
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450
- Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Belgium4 sites, 4 recruiting
- Recruiting
Cliniques Universitaires St-Luc
Brussels, 1200
- Recruiting
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500
- Recruiting
UZ Leuven Gasthuisberg
Leuven, 3000
- Recruiting
Clinique Ste-Elisabeth
Namur, 5000
Mexico4 sites, 4 recruiting
- Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
- Recruiting
RENATI INNOVATION S.A.P.I. de C.V
Guadalajara, Jalisco, 44680
- Recruiting
CENEIT Oncologicos
Mexico City, 03100
- Recruiting
Centro de Infusion Tratamiento e Investigacion Oncologica S DE R
Queretaro Qro, Querétaro, 76090
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron;Oncology
Barcelona, 08035
- Recruiting
Hospital Universitario San Cecilio
Granada, 18016
- Recruiting
Hospital Universitario 12 De Octubre
Madrid, 28041
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Adana Baskent University Hospital
Adana, 01120
- Recruiting
Memorial Ankara Hastanesi
Ankara, 06520
- Recruiting
Bagcilar Medipol Mega Universitesi Hastanesi
Bağcılar, Istanbul, 34214
- Recruiting
Medical Park Seyhan Hospital
Seyhan
United Kingdom4 sites, 4 recruiting
- Recruiting
Blackpool Victoria Hospital
Blackpool, FY3 8NR
- Recruiting
Princess Alexandra Hospital
Harlow, CM20 1QX
- Recruiting
Mount Vernon Cancer Centre
Northwood, Middlesex, HA6 2RN
- Recruiting
Churchill Hospital - Oxford Cancer & Haematology Centre
Oxford, OX3 7LE
About this study
Official title: A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
- Conditions
- Breast Cancer
- Being tested
- Inavolisib, 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
Participants will receive Inavolisib as per the schedule given in the protocol.
FulvestrantDrug
Participants will receive Fulvestrant as per the schedule given in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Inavolisib Dose A plus Fulvestrant | Experimental | Participants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection. Receives: Drug: Inavolisib; Drug: Fulvestrant |
| Inavolisib Dose B plus Fulvestrant | Experimental | Participants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection. Receives: Drug: Inavolisib; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Objective Response Rate (ORR)
Measured: Up to approximately 2 years
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to approximately 2 years
Secondary outcomes (10)
Duration of Response (DOR)
Measured: Up to approximately 2 years
Time to Response (TTR)
Measured: Up to approximately 2 years
Progression-free Survival (PFS)
Measured: Up to approximately 2 years
Percentage of Participants With Treatment Discontinuation due to Adverse Events
Measured: Up to approximately 2 years
Number of Participants Reporting Presence, Frequency, Severity and/or Degree of Interference With Daily Activities of Symptomatic Treatment Toxicities as Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Measured: Up to approximately 2 years
Percentage of Participants Reporting Presence and Frequency of Selected Hyperglycemia Symptoms as Assessed by European Organisation for Research and Treatment of Cancer (EORTC) IL382
Measured: Up to approximately 2 years
Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item General Population, Question 5 (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Measured: Up to approximately 2 years
Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
Measured: Baseline, Up to approximately 2 years
Change from Baseline in Selected Hyperglycemia Symptoms as Assessed by EORTC IL382
Measured: Baseline, Up to approximately 2 years
Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item
Measured: Baseline, Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start18 Feb 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2031 (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.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368998
- Sponsor's protocol ID
- WO46063
- Other IDs
- 2025-522805-39-00, 2025
- Acronym
- optINAVO
- Status last verified
- Nov 2026
- First submitted
- 22 Jan 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07368998
- Acronym / sponsor ID
- optINAVO / WO46063
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2031 (estimated)
- First posted
- 27 Jan 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 purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inavolisib Dose A plus Fulvestrant | Experimental | Drug: Inavolisib, Drug: FulvestrantParticipants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection. |
| Inavolisib Dose B plus Fulvestrant | Experimental | Drug: Inavolisib, Drug: FulvestrantParticipants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
- Confirmation of biomarker eligibility: presence of >= 1 study-eligible PIK3CA mutation
Key exclusion criteria (6 listed)
- Metaplastic breast cancer
- Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
- Requirement for daily supplemental oxygen
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 |
|---|---|---|
| InavolisibParticipants will receive Inavolisib as per the schedule given in the protocol. | Drug | Inavolisib Dose A plus Fulvestrant, Inavolisib Dose B plus Fulvestrant |
| FulvestrantParticipants will receive Fulvestrant as per the schedule given in the protocol. | Drug | Inavolisib Dose A plus Fulvestrant, Inavolisib Dose B plus Fulvestrant |
Primary outcome
Percentage of Participants With Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years
10 secondary outcomes
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to Response (TTR)
Time frame: Up to approximately 2 years
Progression-free Survival (PFS)
Time frame: Up to approximately 2 years
Percentage of Participants With Treatment Discontinuation due to Adverse Events
Time frame: Up to approximately 2 years
Number of Participants Reporting Presence, Frequency, Severity and/or Degree of Interference With Daily Activities of Symptomatic Treatment Toxicities as Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Up to approximately 2 years
Percentage of Participants Reporting Presence and Frequency of Selected Hyperglycemia Symptoms as Assessed by European Organisation for Research and Treatment of Cancer (EORTC) IL382
Time frame: Up to approximately 2 years
Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item General Population, Question 5 (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Time frame: Up to approximately 2 years
Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
Time frame: Baseline, Up to approximately 2 years
Change from Baseline in Selected Hyperglycemia Symptoms as Assessed by EORTC IL382
Time frame: Baseline, Up to approximately 2 years
Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item
Time frame: Baseline, Up to approximately 2 years
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 3 Nov 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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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.
Reference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
34 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inavolisib and Fulvestrant in people with Breast Cancer, run by Hoffmann-La Roche at 34 sites in 8 countries.
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 7 inclusion and 6 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 3 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 34 sites in Argentina, United States, Australia, Belgium, Mexico and 3 more countries. 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.
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 Reference Study ID Number: WO46063 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?
Percentage of Participants With Objective Response Rate (ORR) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.