A clinical study investigating the combination of RAD001 with trastuzumaband paclitaxel in patients with breast cancer

Phase 1

• Conditions: metastatic breast cancer; MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864

• Registration Number: EUCTR2006-001596-37-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-26
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

•Female or male patients = 18 years old with WHO performance status
= 1
•HER-2 over-expressing 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 (phase l)
•Patient resistance to trastuzumab and taxanes (Phase ll)
•Measurable disease according to RECIST (Phase ll)
•Patients neurologically stable with adequate bone marrow, liver and
renal function
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

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 mTOR inhibitors
Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified