Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001164-30 | EudraCT Number |
Not provided
Not provided
Not provided
The Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant. This study will be conducted in patients with metastatic breast cancer who have specific Fibroblast Growth Factor Receptor gene abnormalities and who have previously received conventional therapies to treat their breast cancer, or who are not able to tolerate certain cancer therapies. This study will also evaluate the safety of taking futibatinib, or futibatinib and fulvestrant, by learning about the potential side effects.
This is a Phase 2, open-label, non-randomized, multicenter study designed to evaluate the efficacy and safety of futibatinib (TAS-120) and futibatinib + fulvestrant in up to 168 adult patients with locally advanced/metastatic breast cancer harboring FGFR gene amplifications. Patients will be enrolled to 1 of 4 treatment cohorts based on diagnosis and FGFR gene amplification status, and will receive either single agent futibatinib in Cohorts 1-3 or futibatinib plus fulvestrant in Cohort 4, as follows:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Futibatinib (Cohort 1) | Experimental | Participants with advanced or metastatic hormone receptor - positive (HR+), human epidermal growth factor receptor 2 - negative (HER2-) breast cancer, harboring fibroblast growth factor receptor 2 (FGFR2) gene amplification, with measurable disease received futibatinib, 20 milligrams (mg), oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days. |
|
| Futibatinib (Cohort 2) | Experimental | Participants with advanced or metastatic triple negative breast cancer (TNBC), harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days. |
|
| Futibatinib (Cohort 3) | Experimental | Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days. |
|
| Futibatinib Plus Fulvestrant (Cohort 4) | Experimental | Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Futibatinib | Drug | Futibatinib 20mg once daily on a 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) - Cohorts 1, 2 | ORR was defined as the percentage of participants with a confirmed response of either complete response (CR) or partial response (PR), based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. | At the end of every 2 cycles until disease progression (up to 40 months) |
| Clinical Benefit Rate (CBR) - Cohort 3 | CBR was defined as the percentage of participants with a confirmed response of CR or stable disease (SD) lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10mm. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest | At the end of every 2 cycles until disease progression (up to 40 months) |
| 6-month Progression-free Survival (PFS) Rate - Cohort 4 | The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place. | At the end of every 2 cycles until disease progression (up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate - Cohort 3 | CR rate was defined as the percentage of participants who achieved CR. CR was defined as disappearance of all targets. Any pathological lymph node must have reduction in short axis to <10 mm. Percentages were rounded off to the nearest single decimal place. | At the end of every 2 cycles until disease progression (up to 40 months) |
Not provided
Inclusion Criteria:
Provide written informed consent
Age ≥ 18 years of age
Histologically or cytologically confirmed recurrent locally advanced or metastatic breast cancer not amenable to treatment with curative intent, and the following cohort specific criteria:
A. Cohort 1
B. Cohort 2
C. Cohort 3
D. Cohort 4
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Archival or (preferably) fresh tumor tissue must be available
Adequate organ function
Exclusion Criteria:
History and/or current evidence of any of the following disorders:
Prior treatment with an FGFR inhibitor
A serious illness or medical condition(s)
Brain metastases that are untreated or clinically or radiologically unstable
Pregnant or lactating female
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - AZ | Phoenix | Arizona | 85054 | United States | ||
| USCF |
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 64 participants were enrolled in either Cohorts 1, 2 or 3 to receive futibatinib or to Cohort 4 to receive futibatinib plus fulvestrant.
Participants took part in the study from 28 January 2020 to 06 September 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Futibatinib (Cohort 1) | Participants with advanced or metastatic hormone receptor - positive (HR+), human epidermal growth factor receptor 2 - negative (HER2-) breast cancer, harboring fibroblast growth factor receptor 2 (FGFR2) gene amplification, with measurable disease received futibatinib, 20 milligrams (mg), oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2019 | Oct 15, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Futibatinib plus Fulvestrant | Drug | Futibatinib 20mg once daily on a 28-day cycle and fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on a 28-day cycle. |
|
| Overall Response Rate (ORR) - Cohort 4 | ORR was defined as the percentage of participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. | At the end of every 2 cycles until disease progression (up to 40 months) |
| Clinical Benefit Rate (CBR) - Cohort 1,2, and 4 | CBR was defined as the percentage of participants with a confirmed response of CR, PR or SD lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest single decimal place. | At the end of every 2 cycles until disease progression (up to 40 months) |
| 6-month PFS Rate - Cohorts 1,2, and 3 | The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place. | At the end of every 2 cycles until disease progression (up to 6 months) |
| Progression Free Survival (PFS) | PFS was defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression based on investigator assessment, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure. | At the end of every 2 cycles until disease progression (up to 40 months) |
| Duration of Response (DOR) | DOR was defined as the time from the first documentation of objective response to the to the date of death (any cause) or disease progression, based on Investigator assessment, whichever occurs first. Objective response was defined as participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan-Meier method. | At the end of every 2 cycles until disease progression (up to 40 months) |
| Overall Survival (OS) | OS was defined as the time (in months) from the date of first dose of the study drug to the date of death. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure. | Up to 40 months |
| Number of Participants With Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. | From the first dose of study drug up to 30 days after the last dose (Up to 40 months) |
| Number of Participants With Dose Limiting Toxicities (DLTs) - Cohort 4 | A DLT was defined as any AE that occurs during Cycle 1 that is not clearly attributable to an extraneous cause, such as an underlying disease, occurring in Cycle 1, and meeting at least one of the criteria defined in the protocol. An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. | Cycle 1 (cycle length= 28 days) |
| San Francisco |
| California |
| 94115 |
| United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States |
| Mayo Clinic - FL | Jacksonville | Florida | 32224 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists | Tallahassee | Florida | 32308 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| BIDMC | Boston | Massachusetts | 02115 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic - MN | Rochester | Minnesota | 55905 | United States |
| HCA Midwest Health | Kansas City | Missouri | 64132 | United States |
| Tennessee Oncology | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| Tom Baker Cancer Center | Calgary | T2N 4N2 | Canada |
| SunnyBrook Health Sciences | Toronto | M4N 3M5 | Canada |
| Institut Gustave Roussy | Villejuif | Cedex | 94805 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| AOU Policlinico - Vittorio Emanuele | Catania | 95123 | Italy |
| Istituto Europeo Di Oncologia - IEO | Milan | 20141 | Italy |
| AOU Modena Policlinico | Modena | Italy |
| Ospedale E. Agnelli | Pinerolo | 10064 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Istituto Nazionale Tumori Regina Elena | Roma | 00144 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | 00168 | Italy |
| Centro Hospitalar Universitario Lisboa Norte | Lisbon | 1649-035 | Portugal |
| Porto University | Porto | 4099-001 | Portugal |
| Instituto Portugues de Oncologia do Porto | Porto | 4200-072 | Portugal |
| Vall d'Hebron | Barcelona | 08035 | Spain |
| University Gregorio Marañon | Madrid | 28007 | Spain |
| START Madrid - CIOCC | Madrid | 28050 | Spain |
| HCA Healthcare UK | London | England | W1G 6AD | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | England | M20 4BX | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | England | SM2 5PT | United Kingdom |
| FG001 | Futibatinib (Cohort 2) | Participants with advanced or metastatic triple negative breast cancer (TNBC), harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days. |
| FG002 | Futibatinib (Cohort 3) | Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days. |
| FG003 | Futibatinib Plus Fulvestrant (Cohort 4) | Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated population included all enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Futibatinib (Cohort 1) | Participants with advanced or metastatic HR+, HER2- breast cancer, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days |
| BG001 | Futibatinib (Cohort 2) | Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days. |
| BG002 | Futibatinib (Cohort 3) | Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days. |
| BG003 | Futibatinib Plus Fulvestrant (Cohort 4) | Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) - Cohorts 1, 2 | ORR was defined as the percentage of participants with a confirmed response of either complete response (CR) or partial response (PR), based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. | All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 1 and 2 as pre-specified in Protocol and SAP. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (up to 40 months) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Clinical Benefit Rate (CBR) - Cohort 3 | CBR was defined as the percentage of participants with a confirmed response of CR or stable disease (SD) lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10mm. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), referencing the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest | All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 3 as pre-specified in Protocol and SAP. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (up to 40 months) |
| ||||||||||||||||||||||||||||||
| Primary | 6-month Progression-free Survival (PFS) Rate - Cohort 4 | The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place. | All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 4 as pre-specified in Protocol and SAP. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (up to 6 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Complete Response (CR) Rate - Cohort 3 | CR rate was defined as the percentage of participants who achieved CR. CR was defined as disappearance of all targets. Any pathological lymph node must have reduction in short axis to <10 mm. Percentages were rounded off to the nearest single decimal place. | All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 3 as pre-specified in Protocol and SAP. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (up to 40 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) - Cohort 4 | ORR was defined as the percentage of participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. ORR was calculated based on the best overall response recorded from the start of treatment until progressive disease or start of subsequent new anticancer treatment. Percentages were rounded off to the nearest single decimal place. | All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 4 as pre-specified in Protocol and SAP. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (up to 40 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) - Cohort 1,2, and 4 | CBR was defined as the percentage of participants with a confirmed response of CR, PR or SD lasting at least 24 weeks, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study, including the baseline sum. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Definitive new lesion presence also indicates progression. Percentages were rounded off to the nearest single decimal place. | All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohorts 1, 2 and 4 as pre-specified in Protocol and SAP. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (up to 40 months) |
| ||||||||||||||||||||||||||||||
| Secondary | 6-month PFS Rate - Cohorts 1,2, and 3 | The 6-month PFS rate was defined as the percentage of participants who are alive and progression-free 6 months after the first dose of study drug. Percentages were rounded off to the nearest single decimal place. | All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohorts 1, 2 and 3 as pre-specified in Protocol and SAP. | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of every 2 cycles until disease progression (up to 6 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression based on investigator assessment, whichever occurs first. The PFS was analyzed using a Kaplan-Meier method with PFS time being censored on the date of the last disease assessment. The 95% CI for median PFS was provided using the Kaplan-Meier procedure. | All treated population included all enrolled participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | months | At the end of every 2 cycles until disease progression (up to 40 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the time from the first documentation of objective response to the to the date of death (any cause) or disease progression, based on Investigator assessment, whichever occurs first. Objective response was defined as participants with a confirmed response of either CR or PR, based on Investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters. DOR was estimated using the Kaplan-Meier method. | All treated population included all enrolled participants who received at least 1 dose of study drug. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | Median | Full Range | months | At the end of every 2 cycles until disease progression (up to 40 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time (in months) from the date of first dose of the study drug to the date of death. Participants without a documented death date were censored on the last date they were known to be alive. The OS was presented using a Kaplan-Meier estimate. The 95% CI for median OS was provided using the Kaplan-Meier procedure. | All treated population included all enrolled participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | months | Up to 40 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. | All treated population included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From the first dose of study drug up to 30 days after the last dose (Up to 40 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Dose Limiting Toxicities (DLTs) - Cohort 4 | A DLT was defined as any AE that occurs during Cycle 1 that is not clearly attributable to an extraneous cause, such as an underlying disease, occurring in Cycle 1, and meeting at least one of the criteria defined in the protocol. An AE is defined as any untoward medical occurrence in a clinical study participant and does not necessarily have a causal relationship with the study drug. | All treated population included all enrolled participants who received at least 1 dose of study drug. This outcome measure was planned to be reported for only Cohort 4 as pre-specified in Protocol and SAP. | Posted | Count of Participants | Participants | Cycle 1 (cycle length= 28 days) |
|
|
From the first dose of study drug up to 30 days after the last dose (Up to 40 months)
All treated population included all enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Futibatinib (Cohort 1) | Participants with advanced or metastatic HR+, HER2- breast cancer, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 244 days. | 10 | 17 | 4 | 17 | 16 | 17 |
| EG001 | Futibatinib (Cohort 2) | Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days. | 14 | 21 | 5 | 21 | 21 | 21 |
| EG002 | Futibatinib (Cohort 3) | Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days. | 2 | 4 | 1 | 4 | 4 | 4 |
| EG003 | Futibatinib Plus Fulvestrant (Cohort 4) | Participants with advanced or metastatic HR+ HER2-, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days. | 7 | 22 | 4 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Volvulus | Gastrointestinal disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Hyperphosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Acute promyelocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract obstruction | Renal and urinary disorders | Systematic Assessment |
| ||
| Hepatic ischaemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Hepatic encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pathological fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperphosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dental caries | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral dysaesthesia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Blood cholesterol increased | Investigations | Systematic Assessment |
| ||
| Blood lactate dehydrogenase increased | Investigations | Systematic Assessment |
| ||
| Blood phosphorus increased | Investigations | Systematic Assessment |
| ||
| Blood triglycerides increased | Investigations | Systematic Assessment |
| ||
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
| ||
| Computerised tomogram abnormal | Investigations | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Onycholysis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nail disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nail discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nail dystrophy | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain of skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermal cyst | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Onychomadesis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Spinal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Taste disorder | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Epilepsy | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Parosmia | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Dry eye | Eye disorders | Systematic Assessment |
| ||
| Ocular hyperaemia | Eye disorders | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
| ||
| Vitreous floaters | Eye disorders | Systematic Assessment |
| ||
| Central serous chorioretinopathy | Eye disorders | Systematic Assessment |
| ||
| Corneal disorder | Eye disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
| ||
| Growth of eyelashes | Eye disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymph node pain | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Eye infection | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Erysipelas | Infections and infestations | Systematic Assessment |
| ||
| Herpes simplex reactivation | Infections and infestations | Systematic Assessment |
| ||
| Hordeolum | Infections and infestations | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vulvovaginal dryness | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hot flush | Vascular disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Systematic Assessment |
| ||
| Sleep disorder | Psychiatric disorders | Systematic Assessment |
|
The Sponsor decided to discontinue the study due to strategic considerations and not due to any safety-related concerns.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiho Oncology, Inc | Taiho Oncology, Inc | +1 844-878-2446 | medicalinformation@taihooncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2020 | Oct 15, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000713257 | futibatinib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| OG001 | Futibatinib (Cohort 2) | Participants with advanced or metastatic TNBC, harboring FGFR2 gene amplification, with measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 1066 days. |
| OG002 | Futibatinib Plus Fulvestrant (Cohort 4) | Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received intramuscular (IM) fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days. |
|
|
Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.
|
|
Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days.
| OG003 | Futibatinib Plus Fulvestrant (Cohort 4) | Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days.They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days. |
|
|
| OG002 | Futibatinib (Cohort 3) | Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days. |
| OG003 | Futibatinib Plus Fulvestrant (Cohort 4) | Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days. |
|
|
Participants with advanced or metastatic HR+, HER2- or TNBC, harboring FGFR2 gene amplification, with non-measurable disease received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 252 days. |
| OG003 | Futibatinib Plus Fulvestrant (Cohort 4) | Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days. |
|
|
| OG003 | Futibatinib Plus Fulvestrant (Cohort 4) | Participants with advanced or metastatic HR+ HER2- breast cancer, harboring FGFR1 gene amplification, with measurable disease, received futibatinib, 20 mg, oral tablets, once daily for a continuous 28-day cycle up to maximum of 645 days. They also received IM fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and Day 1 of every subsequent cycle up to maximum of 618 days. |
|
|
|