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Protocol NumberWO43919
Active

2023-04-01 - 2030-12-31

Phase III

Not yet recruiting1

Recruiting5

ICD-10C50.911

Malignant neoplasm of unspecified site of right female breast

ICD-10C50.912

Malignant neoplasm of unspecified site of left female breast

ICD-10C50.919

Malignant neoplasm of unspecified site of unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.9

Malignant neoplasm of female breast, unspecified

A PHASE III, MULTICENTER, RANDOMIZED, OPEN LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS FULVESTRANT VERSUS ALPELISIB PLUS FULVESTRANT IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE, PIK3CA MUTATED LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO PROGRESSED DURING OR AFTER CDK4/6 INHIBITOR AND ENDOCRINE COMBINATION THERAPY

  • Trial Applicant

  • Sponsor

    ROCHE PRODUCTS LTD

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Wei-Pang Chung Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YEN-SHEN LU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Chang Lin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HWEI-CHUNG WANG Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chih-Chiang Hung
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Patients with locally advanced or metastatic breast cancer who have PIK3CA mutations, are hormone receptor-positive, and HER2-negative

Objectives

This trial will evaluate the efficacy and safety of inavolisib plus fulvestrant compared to alpelisib plus fulvestrant in participants with HR+/HER2-, PIK3CA-mutated LA/mBC who have worsened during or after CDK4/6i therapy combined with endocrine therapy (ET).

Test Drug

GDC-0077(Inavolisib)Alpelisib(Piqray)Fulvestrant (Faslodex)

Active Ingredient

Inavolisib
Inavolisib
alpelisib
alpelisib
alpelisib
Fulvestrant

Dosage Form

Tablet
Tablet
vial

Dosage

3mg
9mg
150mg
200mg
50mg
250mg/5ml

Endpoints

Primary therapeutic goal: progression-free survival (PFS)

Inclution Criteria

• Signed participant consent form

• Female or male aged 18 or older at the time of signing the participant consent form

• If female, must meet at least one of the following definitions:

- Postmenopausal, meeting at least one of the following criteria:

• Age ≥ 60 years

(Detailed inclusion criteria can be found in the program description)
• Metaplastic breast cancer

• Prior treatment with any PI3K, AKT, or mTOR inhibitors, or medications that inhibit the PI3K/-AKT/-mTOR pathway for locally advanced or metastatic disease.

• Participant has experienced recurrence after completion of adjuvant CDK4/6i therapy, with written evidence of progression > 12 months, and has not received treatment for metastatic disease.

(Detailed exclusion criteria can be found in the program description)

Exclusion Criteria

• Signed participant consent form

• Female or male aged 18 or older at the time of signing the participant consent form

• If female, must meet at least one of the following definitions:

- Postmenopausal, meeting at least one of the following criteria:

• Age ≥ 60 years

(Detailed inclusion criteria can be found in the program description)
• Metaplastic breast cancer

• Prior treatment with any PI3K, AKT, or mTOR inhibitors, or medications that inhibit the PI3K/-AKT/-mTOR pathway for locally advanced or metastatic disease.

• Participant has experienced recurrence after completion of adjuvant CDK4/6i therapy, with written evidence of progression > 12 months, and has not received treatment for metastatic disease.

(Detailed exclusion criteria can be found in the program description)

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    400 participants

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