Premenopausal breast cancer
Conditions
Interventions
Goserelin acetate 3.6mg depot/ q 4w + Anastrozole 1mg/d
Sponsors
The Japan-Multinational Trial Organization
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients fulfilling the following criteria 1.Premenopausal women at least 20 years old and no more than 55 years old [at time of registration] 2.Patients in whom metastatic or recurrent breast cancer has been confirmed 3.Patients with a measurable lesion [RECIST handling] or assessable bone lesion 4.Patients who have shown resistance to combination therapy with LH-RHa + TAM in prior treatment Patients falling under any of 1 to 4 below 1 Recurrence during postoperative therapy using LH-RHa + TAM 2 Recurrence within 1 year following the completion of postoperative therapy lasting 2 years or more using LH-RHa + TAM 3 Recurrence during postoperative TAM monotherapy in continuation of postoperative therapy lasting 2 years or more using LH-RHa + TAM or recurrence within 1 year following the completion of TAM monotherapy 4 Patients whose symptoms have worsened under combination therapy using LH-RHa + TAM for advanced/recurrent breast cancer 5.ER or PgR positive patients [positive ratio of 10% or more using IHC method] 6.PS 0-1 patients [ECOG Performance Status classification] 7.Among patients being administered a bisphosphonate, patients who have a measurable non-bone lesion in which anticancer effects can be followed up 8.Patients with no serious complications who fulfill the following criteria in clinical laboratory tests WBC at least 4,000/microL and no more than 10,000/microL PLT at least 100,000 /microL Hb at least 10g/dL T.Bil. no more than 1mg/dL AST no more than 60 IU/L ALT no more than 60 IU/L 9.Informed consent must have been obtained from the patient in writing in regard to participation in the trial
Exclusion criteria
Exclusion criteria: Patients falling under any of the following 1.Patients with a history of drug allergy against the test drug and co-administered drug 2.Patients administered another anticancer drug since the prior treatment [LH-RHa + TAM therapy or LH-RHa + TAM followed by TAM therapy] 3.Patients receiving ongoing systemic administration [orally or intravenously] of an adrenal cortex hormone 4.Patients with advanced cancer in another organ less than 5 years after the completion of treatment 5.Patients with a history of thrombotic disease such as deep vein thrombosis or cerebral infarction 6.Patients with a history of severe heart disease such as myocardial infarction, valvular heart disease or heart failure 7.Patients receiving administration of HRT for treatment of menopausal symptoms within 4 weeks of registration 8.Women who are pregnant, lactating or may be [intend to be] pregnant 9.Patients planning treatment with an anticancer drug other than LH-RHa + Anastrozole, a bisphosphonate or radiation therapy on a target lesion following the start of this trial 10.Other cases who the doctor responsible for the trial judges unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Progression free survival 2.Overall survival 3.Clinical benefit rate 4.Adverse events | — |
Countries
Japan
Outcome results
None listed