Study of GnRH-A [Leuprorelin(Lorelin Depot] Plus Leterozole +/- Everolimus for Premenopausal Women With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy of addition of everolimus to letrozole with LHRH agonist in premenopausal metastatic breast cancer patients who failed to tamoxifen treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Everolimus; Letrozole; Leuprolide; Sirolimus

Criteria

Inclusion Criteria:

• Age ≥ 20 years

• Histologically or cytologically confirmed, HER-2 negative breast cancer with recurrent or metastatic disease

• No HER2 overexpressing breast cancer

• Premenopausal status, defined as either

• ER and/or PR 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 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:

• 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