Clinical Trials List
Protocol NumberGO29058
NCT Number(ClinicalTrials.gov Identfier)NCT02340221
2016-06-01 - 2021-12-24
Phase III
Terminated7
ICD-10C50
Malignant neoplasm of breast
A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY OF TASELISIB PLUS FULVESTRANT VERSUS PLACEBO PLUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR-POSITIVE AND HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE DISEASE RECURRENCE OR PROGRESSION DURING OR AFTER AROMATASE INHIBITOR THERAPY
-
Trial Applicant
-
Sponsor
Hoffmann-La Roche
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 邱仁輝 Division of General Surgery
- 林永慧 Division of Radiology
- Ta-Chung Chao Division of Radiation Therapy
- Yi-Fang Tsai Division of General Surgery
- 林燕淑 Division of General Surgery
- 金光亮 Division of General Surgery
- Chun-Yu Liu Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
4 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yao-Chung Wu Division of General Surgery
- Chih-Jung Chen Division of General Surgery
- Liang-Chih Liu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 甘蓉瑜 Division of Gastroenterological Surgery
- Fu Ouyang Division of Gastroenterological Surgery
- Chieh-Han Chuang Division of Gastroenterological Surgery
- Fang-Ming Chen Division of Gastroenterological Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 楊雅雯 Division of General Surgery
- Wei-Wu Chen Division of Hematology & Oncology
- 郭文宏 Division of General Surgery
- 蔡立威 Division of General Surgery
- 林柏翰 Division of General Internal Medicine
- 羅喬 Division of General Surgery
- 張端瑩 Division of Hematology & Oncology
- MING-YANG WANG Division of General Surgery
- YEN-SHEN LU Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
LOCALLY ADVANCED OR METASTATIC BREAST CANCER
Objectives
The efficacy, safety, pharmacology, and patient-reported outcome (PRO) objectives of
this study will be evaluated in postmenopausal women with ER+, HER2-negative, locally
advanced or MBC and who have had recurrence or progression of disease on or after
administration of an aromatase-inhibitor therapy.
EFFICACY OBJECTIVES
The primary efficacy objective for this study is as follows:
• To compare the efficacy between taselisib + fulvestrant versus placebo + fulvestrant
as measured by investigator-assessed PFS in patients with PIK3CA-mutant tumors
The secondary efficacy objectives for this study are as follows:
• To compare the efficacy between taselisib + fulvestrant versus placebo + fulvestrant
as measured by OS in patients with PIK3CA-mutant tumors
• To compare the overall objective response rate (ORR) and CBR between
taselisib + fulvestrant versus placebo + fulvestrant in patients with PIK3CA-mutant
tumors, on the basis of tumor assessments made by the investigator
• To estimate the duration of objective response (DOR) within taselisib + fulvestrant
versus placebo + fulvestrant in patients with PIK3CA-mutant tumors, on the basis of
tumor assessments made by the investigator
Test Drug
TASELISIB and FULVESTRANT
Active Ingredient
Fulvestrant
TASELISIB
TASELISIB
Dosage Form
Tablet
Solution for injection
Solution for injection
Dosage
2
250mg/5ml
250mg/5ml
Endpoints
Primary Outcome Measures :
1. Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
Secondary Outcome Measures :
1. Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
2. Overall Survival (OS) [ Time Frame: From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
3. Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
4. Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 [ Time Frame: Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
5. PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
6. Percentage of Participants With Adverse Events [ Time Frame: From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years. ]
7. Maximum Observed Plasma Concentration (Cmax) of Taselisib [ Time Frame: 1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days) ]
8. Minimum Observed Plasma Concentration (Cmin) of Taselisib [ Time Frame: 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days) ]
9. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score [ Time Frame: Baseline, C2D1 up to C7D1 (each cycle=28 days) ]
10. Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score [ Time Frame: Baseline, C2D1 up to C7D1 (each cycle=28 days) ]
1. Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
Secondary Outcome Measures :
1. Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
2. Overall Survival (OS) [ Time Frame: From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
3. Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
4. Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 [ Time Frame: Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
5. PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 [ Time Frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) ]
6. Percentage of Participants With Adverse Events [ Time Frame: From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years. ]
7. Maximum Observed Plasma Concentration (Cmax) of Taselisib [ Time Frame: 1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days) ]
8. Minimum Observed Plasma Concentration (Cmin) of Taselisib [ Time Frame: 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days) ]
9. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score [ Time Frame: Baseline, C2D1 up to C7D1 (each cycle=28 days) ]
10. Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score [ Time Frame: Baseline, C2D1 up to C7D1 (each cycle=28 days) ]
Inclution Criteria
Inclusion Criteria
Patients must meet the following criteria for study entry:
Disease-Specific Inclusion Criteria
• Women with histologically or cytologically confirmed invasive, ER+ breast cancer:
metastatic or inoperable (not amenable to resection or other local therapy with
curative intent) locally advanced breast cancer
• Patients for whom endocrine therapy (e.g., fulvestrant) is recommended and
treatment with cytotoxic chemotherapy is not indicated at time of entry into the study,
as per national or local treatment guidelines.
• Radiologic/objective evidence of recurrence or progression to the most recent
systemic therapy for breast cancer
• Radiologic/objective evidence of breast cancer recurrence or progression while on
or within 12 months of the end of adjuvant treatment with an AI, or progression while
on or within 1 month of the end of prior AI treatment for locally advanced or MBC.
The AI (letrozole, anastrozole, or exemestane) does not have to be the most recent
treatment before randomization.
• Measurable disease via RECIST v1.1 or non-measurable, evaluable disease with at
least one evaluable bone lesion via RECIST v1.1. Bone lesions that have been
irradiated are not evaluable.
General Inclusion Criteria
• Able and willing to provide written informed consent and to comply with the study
protocol
• Age ≥ 18 years
• ECOG Performance Status of 0 or 1
• Postmenopausal status defined as one of the following:
Age ≥ 60 years
Age < 60 years and postmenopausal as defined by documented
follicle-stimulating hormone and estradiol in the postmenopausal ranges in
addition to being amenorrheic for 12 months in the absence of chemotherapy,
tamoxifen, toremifene, or ovarian suppression
Prior bilateral oophorectomy (≥ 28 days prior to first fulvestrant treatment on
Cycle 1 Day 1)
• Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block
(preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides
from the most recently collected, available tumor tissue for PIK3CA-mutation testing
and for other protocol-mandated exploratory assessments
• A valid cobas PIK3CA mutation result (per central testing) is required for all patients
(e.g., patients with an “invalid” or “failed” PIK3CA mutation result are not permitted
to enroll)
After 120 patients whose breast cancers have a “wild-type” (mutation not
detected result) PIK3CA status have been enrolled, all remaining enrolled
patients must have a breast cancer sample that tests positive for PIK3CA
mutation to be eligible.
• Adequate hematologic and end-organ function, defined by the following laboratory
results obtained within 28 days prior to Cycle 1 Day 1:
ANC ≥ 1500/μL (1.5 × 109
/L)
Platelet count ≥ 100,000/μL (100 × 109
/L)
Hemoglobin ≥ 9.0 g/dL (90 g/L)
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) except in patients with
previously documented Gilbert’s syndrome, in which case total
bilirubin ≤ 3 mg/dL
AST and ALT≤ 1.5 ×ULN, with the following exceptions:
Patients with documented liver metastases: AST and/or ALT ≤ 5.0 ×ULN
Serum creatinine ≤ 1.5 ×ULN or creatinine clearance ≥ 50 mL/min based on
Cockcroft−Gault glomerular filtration rate estimation
• Fasting glucose ≤ 125 mg/dL (6.94 mmol/L)
Patients must meet the following criteria for study entry:
Disease-Specific Inclusion Criteria
• Women with histologically or cytologically confirmed invasive, ER+ breast cancer:
metastatic or inoperable (not amenable to resection or other local therapy with
curative intent) locally advanced breast cancer
• Patients for whom endocrine therapy (e.g., fulvestrant) is recommended and
treatment with cytotoxic chemotherapy is not indicated at time of entry into the study,
as per national or local treatment guidelines.
• Radiologic/objective evidence of recurrence or progression to the most recent
systemic therapy for breast cancer
• Radiologic/objective evidence of breast cancer recurrence or progression while on
or within 12 months of the end of adjuvant treatment with an AI, or progression while
on or within 1 month of the end of prior AI treatment for locally advanced or MBC.
The AI (letrozole, anastrozole, or exemestane) does not have to be the most recent
treatment before randomization.
• Measurable disease via RECIST v1.1 or non-measurable, evaluable disease with at
least one evaluable bone lesion via RECIST v1.1. Bone lesions that have been
irradiated are not evaluable.
General Inclusion Criteria
• Able and willing to provide written informed consent and to comply with the study
protocol
• Age ≥ 18 years
• ECOG Performance Status of 0 or 1
• Postmenopausal status defined as one of the following:
Age ≥ 60 years
Age < 60 years and postmenopausal as defined by documented
follicle-stimulating hormone and estradiol in the postmenopausal ranges in
addition to being amenorrheic for 12 months in the absence of chemotherapy,
tamoxifen, toremifene, or ovarian suppression
Prior bilateral oophorectomy (≥ 28 days prior to first fulvestrant treatment on
Cycle 1 Day 1)
• Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block
(preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides
from the most recently collected, available tumor tissue for PIK3CA-mutation testing
and for other protocol-mandated exploratory assessments
• A valid cobas PIK3CA mutation result (per central testing) is required for all patients
(e.g., patients with an “invalid” or “failed” PIK3CA mutation result are not permitted
to enroll)
After 120 patients whose breast cancers have a “wild-type” (mutation not
detected result) PIK3CA status have been enrolled, all remaining enrolled
patients must have a breast cancer sample that tests positive for PIK3CA
mutation to be eligible.
• Adequate hematologic and end-organ function, defined by the following laboratory
results obtained within 28 days prior to Cycle 1 Day 1:
ANC ≥ 1500/μL (1.5 × 109
/L)
Platelet count ≥ 100,000/μL (100 × 109
/L)
Hemoglobin ≥ 9.0 g/dL (90 g/L)
Total bilirubin ≤ 1.5 × upper limit of normal (ULN) except in patients with
previously documented Gilbert’s syndrome, in which case total
bilirubin ≤ 3 mg/dL
AST and ALT≤ 1.5 ×ULN, with the following exceptions:
Patients with documented liver metastases: AST and/or ALT ≤ 5.0 ×ULN
Serum creatinine ≤ 1.5 ×ULN or creatinine clearance ≥ 50 mL/min based on
Cockcroft−Gault glomerular filtration rate estimation
• Fasting glucose ≤ 125 mg/dL (6.94 mmol/L)
Exclusion Criteria
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:
Disease-Specific Exclusion Criteria
• HER2-positive disease by local laboratory testing (IHC 3+ staining or in situ
hybridization positive)
• Prior treatment with fulvestrant
• Prior treatment with a PI3K inhibitor, mTOR inhibitor (such as everolimus), or AKT
inhibitor. See Appendix 5 for a comprehensive list of excluded treatments.
• Prior anti-cancer therapy within 2 weeks prior to Cycle 1 Day 1
• Prior radiation therapy within 2 weeks prior to Cycle 1 Day 1
• All acute treatment-related toxicity must have resolved to Grade ≤ 1 or be deemed
stable by the investigator
• Prior treatment with > 1 cytotoxic chemotherapy regimen for MBC
• Symptomatic hypercalcemia requiring continued use of bisphosphonate or
denosumab therapy
Use of bisphosphonate therapy or denosumab for other reasons (e.g., bone
metastasis, osteoporosis, etc.) is allowed
• Concurrent hormone replacement therapy
• Known untreated or active CNS metastases (progressing or requiring
anticonvulsants or corticosteroids for symptomatic control); a computed tomography
(CT) scan or magnetic resonance imaging (MRI) of the brain will be performed at
screening if required by the local health authority
Patients with a history of treated CNS metastases are eligible, provided they
meet all of the following criteria:
Evaluable or measurable disease per inclusion criteria outside the CNS is
present.
Radiographic demonstration of improvement upon the completion of
CNS-directed therapy and no evidence of interim progression between the
completion of CNS-directed therapy and the screening radiographic study
No history of intracranial hemorrhage or spinal cord hemorrhage
Minimum of 2 weeks between completion of radiotherapy and
Cycle 1 Day 1 and recovery from significant (Grade ≥ 3) acute toxicity with
no ongoing requirement for ≥ 10 mg of prednisone per day or an equivalent
dose of other corticosteroid
• History of other malignancy within the previous 5 years, except for appropriately
treated carcinoma in situ of the cervix, non-melanoma skin carcinoma,
Stage I uterine cancer, or patients who have undergone potentially curative therapy
with no evidence of disease and are deemed by the treating physician to be at low
risk for recurrence
General Exclusion Criteria
• Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications
• Clinically significant cardiac or pulmonary dysfunction, including the following:
Current uncontrolled Grade ≥ 2 hypertension or unstable angina
Symptomatic congestive heart failure or serious cardiac arrhythmia requiring
treatment, with the exceptions of atrial fibrillation and paroxysmal
supraventricular tachycardia or a conduction abnormality that has been treated
and for which the patient is no longer at risk for serious arrhythmia
(e.g., Wolff-Parkinson-White syndrome treated with surgical ablation)
• Current dyspnea at rest or any requirement for supplemental oxygen therapy to
perform activities of daily living
• History of malabsorption syndrome or other condition that would interfere with
enteral absorption
• Inability or unwillingness to swallow pills or receive intramuscular injections
• Clinically significant history of liver disease, including cirrhosis, current alcohol
abuse, or current known active infection with HIV, hepatitis B virus (HBV),
or hepatitis C virus (HCV)
Active infection is defined as requiring treatment with antiviral therapy or
presence of positive test results for hepatitis B (hepatitis B surface antigen
and/or total hepatitis B core antibody) or HCV antibody. Unless required by
local regulations, patients are not required to have HIV, HBV, or HCV
assessments at screening if these assessments have not been previously
performed.
Patients who test positive for hepatitis B core antibody are eligible only if
test results are also positive for hepatitis B surface antibody and
polymerase chain reaction (PCR) is negative for HBV DNA.
Patients who are positive for HCV serology are only eligible if testing for
HCV RNA is negative.
• History of inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis)
• Active bowel inflammation (e.g., diverticulitis)
• Immunocompromised status due to current known active infection with HIV or
because of the use of immunosuppressive therapies for other conditions
• Need for current chronic corticosteroid therapy (≥ 10 mg of prednisone per day or an
equivalent dose of other anti-inflammatory corticosteroids)
Stable use (i.e., no change in dose within 3 months prior to Cycle 1 Day 1) of
inhaled corticosteroids is allowed.
• Pregnancy, lactation, or breastfeeding
• Current severe, uncontrolled systemic disease (e.g., clinically significant
cardiovascular, pulmonary, or metabolic or infectious disease)
• Major surgical procedure or significant traumatic injury within 28 days prior to
Cycle 1 Day 1 or anticipation of the need for major surgery during the course
of study treatment
• Inability to comply with study and follow-up procedures
• Inability to understand the local language(s) for which the EORTC QLQ-C30, the
modified Breast Cancer module QLQ-BR23, and the EQ-5D questionnaires are
available
Patients who meet any of the following criteria will be excluded from study entry:
Disease-Specific Exclusion Criteria
• HER2-positive disease by local laboratory testing (IHC 3+ staining or in situ
hybridization positive)
• Prior treatment with fulvestrant
• Prior treatment with a PI3K inhibitor, mTOR inhibitor (such as everolimus), or AKT
inhibitor. See Appendix 5 for a comprehensive list of excluded treatments.
• Prior anti-cancer therapy within 2 weeks prior to Cycle 1 Day 1
• Prior radiation therapy within 2 weeks prior to Cycle 1 Day 1
• All acute treatment-related toxicity must have resolved to Grade ≤ 1 or be deemed
stable by the investigator
• Prior treatment with > 1 cytotoxic chemotherapy regimen for MBC
• Symptomatic hypercalcemia requiring continued use of bisphosphonate or
denosumab therapy
Use of bisphosphonate therapy or denosumab for other reasons (e.g., bone
metastasis, osteoporosis, etc.) is allowed
• Concurrent hormone replacement therapy
• Known untreated or active CNS metastases (progressing or requiring
anticonvulsants or corticosteroids for symptomatic control); a computed tomography
(CT) scan or magnetic resonance imaging (MRI) of the brain will be performed at
screening if required by the local health authority
Patients with a history of treated CNS metastases are eligible, provided they
meet all of the following criteria:
Evaluable or measurable disease per inclusion criteria outside the CNS is
present.
Radiographic demonstration of improvement upon the completion of
CNS-directed therapy and no evidence of interim progression between the
completion of CNS-directed therapy and the screening radiographic study
No history of intracranial hemorrhage or spinal cord hemorrhage
Minimum of 2 weeks between completion of radiotherapy and
Cycle 1 Day 1 and recovery from significant (Grade ≥ 3) acute toxicity with
no ongoing requirement for ≥ 10 mg of prednisone per day or an equivalent
dose of other corticosteroid
• History of other malignancy within the previous 5 years, except for appropriately
treated carcinoma in situ of the cervix, non-melanoma skin carcinoma,
Stage I uterine cancer, or patients who have undergone potentially curative therapy
with no evidence of disease and are deemed by the treating physician to be at low
risk for recurrence
General Exclusion Criteria
• Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications
• Clinically significant cardiac or pulmonary dysfunction, including the following:
Current uncontrolled Grade ≥ 2 hypertension or unstable angina
Symptomatic congestive heart failure or serious cardiac arrhythmia requiring
treatment, with the exceptions of atrial fibrillation and paroxysmal
supraventricular tachycardia or a conduction abnormality that has been treated
and for which the patient is no longer at risk for serious arrhythmia
(e.g., Wolff-Parkinson-White syndrome treated with surgical ablation)
• Current dyspnea at rest or any requirement for supplemental oxygen therapy to
perform activities of daily living
• History of malabsorption syndrome or other condition that would interfere with
enteral absorption
• Inability or unwillingness to swallow pills or receive intramuscular injections
• Clinically significant history of liver disease, including cirrhosis, current alcohol
abuse, or current known active infection with HIV, hepatitis B virus (HBV),
or hepatitis C virus (HCV)
Active infection is defined as requiring treatment with antiviral therapy or
presence of positive test results for hepatitis B (hepatitis B surface antigen
and/or total hepatitis B core antibody) or HCV antibody. Unless required by
local regulations, patients are not required to have HIV, HBV, or HCV
assessments at screening if these assessments have not been previously
performed.
Patients who test positive for hepatitis B core antibody are eligible only if
test results are also positive for hepatitis B surface antibody and
polymerase chain reaction (PCR) is negative for HBV DNA.
Patients who are positive for HCV serology are only eligible if testing for
HCV RNA is negative.
• History of inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis)
• Active bowel inflammation (e.g., diverticulitis)
• Immunocompromised status due to current known active infection with HIV or
because of the use of immunosuppressive therapies for other conditions
• Need for current chronic corticosteroid therapy (≥ 10 mg of prednisone per day or an
equivalent dose of other anti-inflammatory corticosteroids)
Stable use (i.e., no change in dose within 3 months prior to Cycle 1 Day 1) of
inhaled corticosteroids is allowed.
• Pregnancy, lactation, or breastfeeding
• Current severe, uncontrolled systemic disease (e.g., clinically significant
cardiovascular, pulmonary, or metabolic or infectious disease)
• Major surgical procedure or significant traumatic injury within 28 days prior to
Cycle 1 Day 1 or anticipation of the need for major surgery during the course
of study treatment
• Inability to comply with study and follow-up procedures
• Inability to understand the local language(s) for which the EORTC QLQ-C30, the
modified Breast Cancer module QLQ-BR23, and the EQ-5D questionnaires are
available
The Estimated Number of Participants
-
Taiwan
18 participants
-
Global
600 participants
