Breast cancer
Conditions
Interventions
Hormone therapy: treatment of physician'
s choice (TPC)
Hormone therapy + capecitabine: hormone therapy, treatment of physician'
s choice (TPC)
capecitabine
1,657 mg/m2/day orally in 2 divided doses for 3 weeks followed by 1week rest
Sponsors
KBCSG-TR(Kinki Breast Cancer Study Group-TR)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Signed written informed consent (2)Female >=20 years old (3)Advanced breast cancer with distant metastases or inoperable recurrent breast cancer (3)Estrogen reseptor positive assessed by immunohistochemistory (IHC (5)HER2 negative* *FISH negative or IHC <=2+; IHC =2+ has to be tested by FISH for negative status (6)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (7)Life expectancy of at least 12 months (8)With measurable lesoin defined by RECIST version 1.1 With stimative diseases, e.g. small lesions (long-axis diameter <10 mm or short-axis diameter of pathological lymph nodes >=10 and <15mm) only, bone lesions only, mediastinum disease only, diffuse skin lesions only are allowed. (9)Previously treated with no more than one chemotherapy regimen for metastatic or inoperable recurrent breast cancer (10)Efficacy from hormone therapy is expected (11)No previous treatment with paclitaxel (including nab-paclitaxel) or oral fluoropyrimidines. Eligible if paclitaxel or oral fluoropyrimidines were administered only in neo-adjuvant or adjuvant setting, or 12 months prior to registration. (12)No effect from previous treatments and examinations (13)Adequate organ function defined by the following laboratory values (within 2 weeks prior to first dose): Absolute neutrophil count >=1,500/mm3 Platelets >=100x104/mm3 Hemoglobin >=9.0g/dL Serum bilirubin <=1.5 mg/dL AST and ALT <=100 IU/L(<=200 in patients with known liver involvement) Serum creatinine <=1.5 mg/dL Proteinuria <=1+
Exclusion criteria
Exclusion criteria: (1)Prior therapy with bevacizumab (2)Hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, chinese hamster ovary cell derived products or other recombinant humanized antibodies (3)Hypersensitivity to capecitabine or fluoropyrimidines (4)Clinically or radiographically confirmed brain metastases (5)Treated brain metastasis within 3 months prior to registration (6)Women who is pregnant, lactating or declined contraception (7)Obvious infection or inflammation (with fever >= degrees centigrade (8)Active hepatitis (9)Patients with a nonhealing wound or fracture. (10)Massive pleural effusion, ascites or cardiac effusion (11)Uncontrolled hypertension (SBP>150 mmHg, DBP>100 mmHg). (12)Patients receiving anticoagulant therapy within 10 days prior to registration (aspirin <=325 mg/day is allowed.), or patients need anticoagulant therapy during study (13)Under coutinuous corticosteroid administration. (14)Symptomatic congestive heart failure,unstable angina, uncontrolled arrhythmia, myocardial infarction within 12 months prior to study entry. (15)Idiopathic pulmonary fibrosis, interstitial lung disease (16)Current or previous history (within 12 months) of symptomatic cerebrovascular disease (17)Current or previous history (within 12 months) of deep vein thrombosis or pulmonary embolism. (18)Current or previous history (within 12 months) of GI perforation (19)Active peptic ulcer (20)Planned surgery within study term (21)Synchronous or metachronous tumors with <5 years disease-free period (22)Symptomtic peripheral neuropathy with functional disorders. (23)Patients ineligible to the study based on decision of attending physician or site principal investigators.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Time to failure of strategy, response rate of reintroduction therapy, progression free survival of reintroduction therapy, time to treatment failure of reintroduction therapy, overall survival from first registration , safety | — |
Primary
| Measure | Time frame |
|---|---|
| Progression free survival of maintenance therapy | — |
Countries
Japan
Contacts
Public ContactNorikazu Masuda
National Hospital Organization, Osaka National Hospital Department of Surgery, Breast Oncology
Outcome results
None listed