A phase II, open label study of everolimus with fulvestrant in postmenopausal women with hormone receptor-positive HER-2 negative AI and fulvestrant treated, locally advanced or metastatic breast cancer (mBC), who progressed on or after mTor inhibitor based treatment.

Z Brussel0 sitesJuly 16, 2013

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: postmenopausal women with hormone receptor-positive, Her2 negative AI and fulvestrant treated, locally advanced or metastatic breast cancer, who progressed on prior fulvestrant and also received prior treatment with everolimus and exemestane. The treatment with fulvestrant is not required to be the last treatment administered as long as at some point in time a progression on fulvestrant has been ascertained.
Sponsor: Z Brussel
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

July 16, 2013

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Z Brussel

•1\. Postmenopausal women. Postmenopausal status is defined either by:
•\- Age \= 55 years and one year or more of amenorrhea
•\- Age \< 55 years and one year or more of amenorrhea, with an estradiol assay \< 20 pg/ml
•\- Surgical menopause with bilateral oophorectomy
•2\. Organ function:
•\- ALT/AST \<2\.5 ULN or \<5 if hepatic metastases
•\- Bilirubine less than 2\.5 ULN
•\- PLT \> 100\.000 10\*6/L
•\- WBC \>3\.5 and ANC\> 1\.5 10\*9 g/L
•\- Hb \> 9\.0 g/dL

•1\.HER2\-overexpressing patients by local laboratory testing (FISH positive).
•2\.Known hypersensitivity to mTOR inhibitors.
•3\.Currently receiving hormone replacement therapy.
•4\.Patients receiving concomitant immunosuppressive agents or chronic systemic corticosteroid use;
•5\.Patients with symptomatic visceral disease in need of urgent disease control: e.g. significant dyspnea related to pulmonary lymphangitic carcinomatosis or lung metastases or clinically meaningful symptomatic liver metastasis at the judgment of treating investigator.
•6\.Metastases estimated as more than a third of the liver as defined by sonogram and/or CT scan.
•7\. Symptomatic brain or other CNS metastases. Previously treated symptomatic brain metastases are allowed provided the patient is free of symptoms, prior radiotherapy for brain metastasis was more than four weeks before enrollment and the dose of corticosteroids is low and stable for at least two weeks prior to enrollment.
•8\. Patients with a known immunodeficiency disease.
•9\. Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.
•10\. Patients with a known history of HIV seropositivity.