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NCT Number: NCT07347600

A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.

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Key information

Conditions

Locally Advanced Breast Cancer Breast Diseases Breast Neoplasms Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy
  • Participants must receive the treatment of inavolisib for the first time
  • PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay [Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)] by testing of blood or tumor tissue prior to the initiation of inavolisib

Exclusion criteria

  • Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant
  • Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling
  • At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study

Treatment and study plan

Inavolisib

Drug

Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

Other names: GDC-0077

Palbociclib

Drug

Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

Fulvestrant

Drug

Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.

Primary outcomes

  1. Real-world Progression-free Survival (rwPFS)

    Time frame: From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 months)

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 36 months

  2. Real-world Time to Progression (rwTTP)

    Time frame: From index date to first occurrence of PD (up to approximately 36 months)

  3. Number of Participants With Real-world Tumor Response (rwTR) to the Treatment

    Time frame: Up to approximately 36 months

  4. Real-world Duration of Response (rwDoR)

    Time frame: From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months)

  5. Real-world Time-to-treatment Discontinuation (rwTTD)

    Time frame: From index date to inavolisib discontinuation, new anti-cancer therapy initiation or death from any cause (up to approximately 36 months)

  6. Real-world Time to Next Treatment (rwTTNT)

    Time frame: From index date to new anti-cancer therapy (up to approximately 36 months)

  7. Real-world Time to Chemotherapy (rwTTC)

    Time frame: From index date to date of chemotherapy initiation (up to approximately 36 months)

  8. Treatment Duration of Inavolisib

    Time frame: Up to approximately 36 months

  9. Total Dose of Inavolisib Received

    Time frame: Up to approximately 36 months

  10. Number of Participants Who Experience Dose Modification, Including Missing Doses, Dose Interruption, Dose Reduction, or Early Discontinuation

    Time frame: Up to approximately 36 months

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: ML46361 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 Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)

Acronym: reaINAVO

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 16, 2026
Registry last updated
Jul 10, 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.

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