Menu
Recruiting NCT07368998

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

Phase II Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inavolisib, Fulvestrant.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Belgium, Mexico +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Argentina · 6 centers
  • Instituto de Oncologia de Rosario — Rosario
  • Centro Oncologico Korben — Ciudad Autonoma Buenos Aires
  • Hospital Privado - Centro Medico de Córdoba — Córdoba
  • Centro Oncologico Riojano Integral (CORI) — La Rioja
  • Hospital Provincial del Centenario — Rosario
  • Centro Oncológico de Excelencia — San Juan
Belgium · 4 centers
  • Cliniques Universitaires St-Luc — Brussels
  • Jessa Zkh (Campus Virga Jesse) — Hasselt
  • UZ Leuven Gasthuisberg — Leuven
  • Clinique Ste-Elisabeth — Namur
Mexico · 4 centers
  • Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara
  • RENATI INNOVATION S.A.P.I. de C.V — Guadalajara
  • Centro de Infusion Tratamiento e Investigacion Oncologica S DE R — Queretaro Qro
  • CENEIT Oncologicos — Mexico City
Spain · 4 centers
  • Hospital Universitari Vall d'Hebron;Oncology — Barcelona
  • Hospital Universitario San Cecilio — Granada
  • Hospital Universitario 12 De Octubre — Madrid
  • Hospital Clinico Universitario de Valencia — Valencia
Turkey (Türkiye) · 4 centers
  • Bagcilar Medipol Mega Universitesi Hastanesi — Bağcılar
  • Adana Baskent University Hospital — Adana
  • Memorial Ankara Hastanesi — Ankara
  • Medical Park Seyhan Hospital — Seyhan
United States · 3 centers
  • Los Angeles Cancer Network — Los Angeles
  • Cancer Specialists of North Florida — Jacksonville
  • Astera Cancer Care East Brunswick — East Brunswick
Australia · 3 centers
  • Blacktown Hospital — Blacktown
  • Coffs Harbour Health Campus — Coffs Harbour
  • Bendigo Cancer Centre — Bendigo
United Kingdom · 3 centers
  • Blackpool Victoria Hospital — Blackpool
  • Princess Alexandra Hospital — Harlow
  • Mount Vernon Cancer Centre — Northwood, Middlesex

Identifiers

NCT: NCT07368998 · WO46063 · 2025-522805-39-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗