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

Completed · Phase 1

Conditions studied: Metastatic Breast Cancer

In brief

Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer. Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Key facts

Study ID

NCT00426556

Run by

Novartis Pharmaceuticals

People needed

88

Starts

2007-07-01

Expected to finish

2014-03-01

Last updated by the study team

2015-12-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 inclusion/exclusion criteria may apply

Where it is running

• Wilshire Oncology Medical Group La Verne — *see Various Departments*, California, United States
• Compassionate Cancer Care Medical Group Dept.ofCCCMG — Fountain Valley, California, United States
• Loma Linda University Dept.ofLomaLindaCancerCent(3) — Loma Linda, California, United States
• University of California at Los Angeles Dept.of UCLA Dept.ofMed. — Los Angeles, California, United States
• Florida Cancer Research Institute — Davie, Florida, United States
• Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) — Atlanta, Georgia, United States
• North Shore University Health System — Evanston, Illinois, United States
• Peninsula Regional Medical Center Deptof Oncology and Hematology — Salisbury, Maryland, United States
• Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CRAD001J2101 — St Louis, Missouri, United States
• Cancer Centers of the Carolinas CC of C -Eastside — Greenville, South Carolina, United States
• Sammons Cancer Center - Texas Oncology — Dallas, Texas, United States
• Novartis Investigative Site — Charleroi, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Turnhout, Belgium
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Saint-Herblain Cédex, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Maastricht, Netherlands
• Novartis Investigative Site — Lleida, Catalonia, Spain

Full record on ClinicalTrials.gov

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