Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07368998

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Oncologia de Rosario, Rosario, Santa Fe Province, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inavolisib

Drug

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

Fulvestrant

Drug

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

Primary outcomes

  1. Percentage of Participants With Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

  2. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Duration of Response (DOR)

    Time frame: Up to approximately 2 years

  2. Time to Response (TTR)

    Time frame: Up to approximately 2 years

  3. Progression-free Survival (PFS)

    Time frame: Up to approximately 2 years

  4. Percentage of Participants With Treatment Discontinuation due to Adverse Events

    Time frame: Up to approximately 2 years

  5. 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

  6. 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

  7. 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

  8. Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE

    Time frame: Baseline, Up to approximately 2 years

  9. Change from Baseline in Selected Hyperglycemia Symptoms as Assessed by EORTC IL382

    Time frame: Baseline, Up to approximately 2 years

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: optINAVO

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Jan 27, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.