Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

Novartis

Status and phase: Completed; Phase 1

Conditions: Neoplasm Metastasis; Breast Neoplasms

Treatments: Drug: everolimus (RAD001)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426530

2006-001595-20 (EudraCT Number)

CRAD001J2102

Details and patient eligibility

About

This study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast cancer.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female or male patients ≥18 years with WHO performance status ≤ 1
• HER-2 overexpressing metastatic breast cancer cells confirmed by histology
• Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy
• Patients neurologically stable with adequate bone marrow, liver and renal function

Exclusion criteria

• Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start
• Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start
• Patients who have previously received vinorelbine or mTOR inhibitors

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

RAD001 Daily Schedule

Experimental group

Description:

5mg or 10mg

Treatment:

Drug: everolimus (RAD001)

RAD001 Weekly Schedule

Experimental group

Description:

30mg

Treatment:

Drug: everolimus (RAD001)