NCT07368998

Brief 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 kinase inhibitor (CDKi) setting.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
66mo left

Started Feb 2026

Typical duration for phase_2 breast-cancer

Geographic Reach
5 countries

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Feb 2026Oct 2031

First Submitted

Initial submission to the registry

January 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2031

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

January 22, 2026

Last Update Submit

April 9, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Objective Response Rate (ORR)

    Up to approximately 2 years

  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Up to approximately 2 years

Secondary Outcomes (10)

  • Duration of Response (DOR)

    Up to approximately 2 years

  • Time to Response (TTR)

    Up to approximately 2 years

  • Progression-free Survival (PFS)

    Up to approximately 2 years

  • Percentage of Participants With Treatment Discontinuation due to Adverse Events

    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)

    Up to approximately 2 years

  • +5 more secondary outcomes

Study Arms (2)

Inavolisib Dose A plus Fulvestrant

EXPERIMENTAL

Participants will recieve an inavolisib tablet orally (PO) along with fulvestrant as an intramuscular (IM) injection.

Drug: InavolisibDrug: Fulvestrant

Inavolisib Dose B plus Fulvestrant

EXPERIMENTAL

Participants will recieve an inavolisib tablet PO along with fulvestrant as an IM injection.

Drug: InavolisibDrug: Fulvestrant

Interventions

InavolisibDRUG

Participants will receive Inavolisib as per the schedule given in the protocol.

Inavolisib Dose A plus FulvestrantInavolisib Dose B plus Fulvestrant
FulvestrantDRUG

Participants will receive Fulvestrant as per the schedule given in the protocol.

Inavolisib Dose A plus FulvestrantInavolisib Dose B plus Fulvestrant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Los Angeles Cancer Network

Los Angeles, California, 90017-4803, United States

RECRUITING

Astera Cancer Care East Brunswick

East Brunswick, New Jersey, 08816, United States

RECRUITING

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

RECRUITING

Jessa Zkh (Campus Virga Jesse)

Hasselt, 3500, Belgium

RECRUITING

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Hospital Universitari Vall d'Hebron;Oncology

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario San Cecilio

Granada, 18016, Spain

RECRUITING

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Bagcilar Medipol Mega Universitesi Hastanesi

Bağcılar, Istanbul, 34214, Turkey (Türkiye)

RECRUITING

Adana Baskent University Hospital

Adana, 01120, Turkey (Türkiye)

RECRUITING

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Medical Park Seyhan Hospital

Seyhan, Turkey (Türkiye)

RECRUITING

Blackpool Victoria Hospital

Blackpool, FY3 8NR, United Kingdom

RECRUITING

Princess Alexandra Hospital

Harlow, CM20 1QX, United Kingdom

RECRUITING

Mount Vernon Cancer Centre

Northwood, Middlesex, HA6 2RN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

inavolisibFulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WO46063 https://forpatients.roche.com/

CONTACT

888-662-6728global-roche-genentech-trials@gene.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 27, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

October 31, 2031

Study Completion (Estimated)

October 31, 2031

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

Locations

ES(4)TU(4)GB(3)US(2)BE(3)