NCT07368998RecruitingPhase 2
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 22 Jan 2026
- Start date
- 18 Feb 2026
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07368998
- EU CT number
- 2025-522805-39-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 18 Feb 2026 to the primary completion date, 31 Oct 2028
- 34 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
- Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
Other illness
- Metaplastic breast cancer
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Symptomatic active lung disease, including pneumonitis
Other
- Requirement for daily supplemental oxygen
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Oncologico Korben Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Hospital Privado Centro Medico de Cordoba Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Centro Oncologico Riojano Integral (Cori) Coordinator of this site? Confirm its status | La Rioja | Argentina | Recruiting |
| Hospital Provincial del Centenario Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Instituto de Oncología de Rosario Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Centro Oncologico de Excelencia Coordinator of this site? Confirm its status | San Juan | Argentina | Recruiting |
| Bendigo Cancer Centre Coordinator of this site? Confirm its status | Bendigo | Australia | Recruiting |
| Blacktown Hospital Coordinator of this site? Confirm its status | Blacktown | Australia | Recruiting |
| Coffs Harbour Health Campus Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Recruiting |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Namur | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Blackpool Victoria Hospital Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Recruiting |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Harlow | United Kingdom | Recruiting |
| Mount Vernon Cancer Centre Coordinator of this site? Confirm its status | Northwood, Middlesex | United Kingdom | Recruiting |
| Churchill Hospital - Oxford Cancer & Haematology Centre Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
| Renati Innovation S.A.P.I. DE C.V. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Hospital Civil de Guadalajara Fray Antonio Alcalde Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| CENEIT Oncologicos Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
| Centro de Infusion Tratamiento e Investigacion Oncologica S DE R Coordinator of this site? Confirm its status | Queretaro Qro | Mexico | Recruiting |
| Astera Cancer Care - East Brunswick Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| Cancer Specialists of North Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| HCA Midwest Division Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Los Angeles Cancer Network Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Adana Baskent University Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| Memorial Ankara Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Bagcilar Medipol Mega Universitesi Hastanesi Coordinator of this site? Confirm its status | Bağcılar | Turkey (Türkiye) | Recruiting |
| Medical Park Seyhan Hospital Coordinator of this site? Confirm its status | Seyhan | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.