A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS A CDK4/6 INHIBITOR AND LETROZOLE VERSUS PLACEBO PLUS A CDK4/6 INHIBITOR AND LETROZOLE IN PATIENTS WITH ENDOCRINE-SENSITIVE PIK3CA-MUTATED, HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER.

Registry ID

WO45654

Source registry

HEALTH_CANADA

Status

Ongoing

Phase

PHASE3

Study type

INTERVENTIONAL

Sponsor

HOFFMANN-LA ROCHE LIMITED

Start date

2025-04-28

Last update

2025-02-18

Conditions

• BREAST CANCER, HORMONE RECEPTOR POSITIVE, HER2 NEGATIVE LOCALLY ADVANCED OR METASTATIC

Related clinical trials

• AN OPEN-LABEL, MULTI-CENTER, PHASE I/IB STUDY OF IEV407 AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER
• AN OPEN-LABEL, RANDOMIZED MULTICENTER PHASE 3 STUDY OF PF-07220060 + LETROZOLE VS CDK4/6 INHIBITOR+ LETROZOLE IN PARTICIPANTS>18 YEARS OF AGE WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC TREATMENT.
• A PHASE 2, RANDOMIZED, ACTIVE-CONTROLLED, OPEN-LABEL, MULTICENTER STUDY OF BELZUTIFAN PLUS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE UNRESECTABLE LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER PROGRESSION ON PREVIOUS ENDOCRINE THERAPY (LITESPARK-029)
• A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF OP-1250 MONOTHERAPY VS STANDARD OF CARE FOR THE TREATMENT OF ER+, HER2- ADVANCED OR METASTATIC BREAST CANCER FOLLOWING ENDOCRINE AND CDK 4/6 INHIBITOR THERAPY (OPERA-01)
• AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR¿S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY (FOURLIGHT-1)
• AN OPEN LABEL, RANDOMIZED, MULTICENTER STUDY COMPARING THE EFFICACY AND SAFETY OF THE COMBINATION OF LASOFOXIFENE AND ABEMACICLIB TO THE COMBINATION OF FULVESTRANT AND ABEMACICLIB FOR THE TREATMENT OF PRE- AND POSTMENOPAUSAL WOMEN AND MEN WITH LOCALLY ADVANCED OR METASTATIC ER+/HER2- BREAST CANCER WITH AN ESR1 MUTATION

View on source registry