None listed
Conditions
Interventions
Drug : control arm: Everolimus 10mg PE QD for 28days + Leuprorelin 3.75mg SC per every 28Days + Letrozole 2.5 mg PO QD for 28Days
experimental arm: Leuprorelin 3.75mg SC per every 28Days + Letrozole 2
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: •Age = 20 years •Histologically or cytologically confirmed, HER-2(human epidermal growth factor receptor 2) negative breast cancer with recurrent or metastatic disease •No HER2 overexpressing breast cancer •Premenopausal status, defined as either •ER(estrogen receptor) and/or PR(progesterone receptor) positive •Progressive disease on tamoxifen treatment or sequential or combined treatment of tamoxifen and GnRH agonist as a palliative or an adjuvant endocrine treatment •Duration of tamoxifen treatment should be at least 3 months or more •No prior treatment with an aromatase inhibitor or inactivator or fulvestrant, or mTOR(Mammalian target of rapamycin) inhibitors •One line of chemotherapy in metastatic setting is permitted •ECOG performance status 0,1 or 2 •At least one measurable lesion or mainly lytic bone lesions in the absence of measurable disease •Adequate hematologic, liver and kidney function
Exclusion criteria
Exclusion criteria: •Pregnant women or patients in lactation •More than one line of prior chemotherapy for metastatic breast cancer •GnRH agonist with tamoxifen treatment within 2 weeks. •Active malignancy other than breast cancer, in situ carcinoma of the cervix, controlled resected thyroid well differentiated carcinoma or non-melanomatous skin cancer in the past 5 years •Active cardiovascular disease such as angina, ventricular tachycardia, uncontrolled hypertension •Active uncontrolled infection •Symptomatic brain metastases •Lymphangitic carcinomatosis involving = 50% of the lungs •Evidence of metastases involving more than one third of the liver on sonogram or CT •Patients not able or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response rate;Clinical benefit rate (CBR);Overall survival;Number of patients with adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactHYUNJOO LEE
Asan Medical Center
Outcome results
None listed