Clinical trial NCT00426556: Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
Official title: A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Keywords: Breast cancer
Cancer of the breast
Human mammary carcinoma
HER-2
Metastatic
everolimus
trastuzumab
paclitaxel
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-24
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

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 inclusion/exclusion criteria may apply

Primary outcomes:
measure: Phase II: Overall Response Rate
timeFrame: every 8 - 9 weeks until disease progression or a new lesion is identified
Secondary outcomes:
measure: Phase I: Best Overall Response (BOR)
timeFrame: every 8 - 9 weeks until disease progression or a new lesion is identified
measure: Phase II: Progression Free Survival (PFS)
timeFrame: every 8 - 9 weeks until disease progression or a new lesion is identified
measure: Phase II: Overall Survival (OS)
timeFrame: every 3 months until death
Other outcomes:
Locations:
city: *see Various Departments*
country: United States
facility: Wilshire Oncology Medical Group La Verne
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group Dept.ofCCCMG
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Dept.ofLomaLindaCancerCent(3)
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles Dept.of UCLA Dept.ofMed.
state: California
city: Davie
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
state: Georgia
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center Deptof Oncology and Hematology
state: Maryland
city: St. Louis
country: United States
facility: Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CRAD001J2101
state: Missouri
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas CC of C -Eastside
state: South Carolina
city: Dallas
country: United States
facility: Sammons Cancer Center - Texas Oncology
state: Texas
city: Charleroi
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Turnhout
country: Belgium
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Saint-Herblain Cédex
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 9
country: France
facility: Novartis Investigative Site
city: Villejuif Cedex
country: France
facility: Novartis Investigative Site
city: Maastricht
country: Netherlands
facility: Novartis Investigative Site
city: Lleida
country: Spain
facility: Novartis Investigative Site
state: Cataluna
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: