Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (34)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Oncologico Korben
Coordinator of this site? Confirm its status
Ciudad Autonoma Buenos AiresArgentinaRecruiting
Hospital Privado Centro Medico de Cordoba
Coordinator of this site? Confirm its status
CórdobaArgentinaRecruiting
Centro Oncologico Riojano Integral (Cori)
Coordinator of this site? Confirm its status
La RiojaArgentinaRecruiting
Hospital Provincial del Centenario
Coordinator of this site? Confirm its status
RosarioArgentinaRecruiting
Instituto de Oncología de Rosario
Coordinator of this site? Confirm its status
RosarioArgentinaRecruiting
Centro Oncologico de Excelencia
Coordinator of this site? Confirm its status
San JuanArgentinaRecruiting
Bendigo Cancer Centre
Coordinator of this site? Confirm its status
BendigoAustraliaRecruiting
Blacktown Hospital
Coordinator of this site? Confirm its status
BlacktownAustraliaRecruiting
Coffs Harbour Health Campus
Coordinator of this site? Confirm its status
Coffs HarbourAustraliaRecruiting
Sir Charles Gairdner Hospital
Coordinator of this site? Confirm its status
PerthAustraliaRecruiting
JESSA Ziekenhuis
Coordinator of this site? Confirm its status
HasseltBelgiumRecruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Coordinator of this site? Confirm its status
NamurBelgiumRecruiting
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumRecruiting
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Clínico San Cecilio
Coordinator of this site? Confirm its status
GranadaSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Blackpool Victoria Hospital
Coordinator of this site? Confirm its status
BlackpoolUnited KingdomRecruiting
Princess Alexandra Hospital
Coordinator of this site? Confirm its status
HarlowUnited KingdomRecruiting
Mount Vernon Cancer Centre
Coordinator of this site? Confirm its status
Northwood, MiddlesexUnited KingdomRecruiting
Churchill Hospital - Oxford Cancer & Haematology Centre
Coordinator of this site? Confirm its status
OxfordUnited KingdomRecruiting
Renati Innovation S.A.P.I. DE C.V.
Coordinator of this site? Confirm its status
GuadalajaraMexicoRecruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Coordinator of this site? Confirm its status
GuadalajaraMexicoRecruiting
CENEIT Oncologicos
Coordinator of this site? Confirm its status
Mexico CityMexicoRecruiting
Centro de Infusion Tratamiento e Investigacion Oncologica S DE R
Coordinator of this site? Confirm its status
Queretaro QroMexicoRecruiting
Astera Cancer Care - East Brunswick
Coordinator of this site? Confirm its status
East BrunswickUnited StatesRecruiting
Cancer Specialists of North Florida
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
HCA Midwest Division
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Los Angeles Cancer Network
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Adana Baskent University Hospital
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Recruiting
Memorial Ankara Hastanesi
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Bagcilar Medipol Mega Universitesi Hastanesi
Coordinator of this site? Confirm its status
BağcılarTurkey (Türkiye)Recruiting
Medical Park Seyhan Hospital
Coordinator of this site? Confirm its status
SeyhanTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.