Metastatic Breast Cancer Clinical Trial
Official title:
A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Novartis Investigative Site | Charleroi | |
Belgium | Novartis Investigative Site | Liege | |
Belgium | Novartis Investigative Site | Turnhout | |
France | Novartis Investigative Site | Paris | |
France | Novartis Investigative Site | Saint-Herblain Cédex | |
France | Novartis Investigative Site | Toulouse Cedex 9 | |
France | Novartis Investigative Site | Villejuif Cedex | |
Netherlands | Novartis Investigative Site | Maastricht | |
Spain | Novartis Investigative Site | Lleida | Cataluna |
United States | Wilshire Oncology Medical Group La Verne | *see Various Departments* | California |
United States | Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) | Atlanta | Georgia |
United States | Sammons Cancer Center - Texas Oncology | Dallas | Texas |
United States | Florida Cancer Research Institute | Davie | Florida |
United States | North Shore University Health System | Evanston | Illinois |
United States | Compassionate Cancer Care Medical Group Dept.ofCCCMG | Fountain Valley | California |
United States | Cancer Centers of the Carolinas CC of C -Eastside | Greenville | South Carolina |
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 | 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 |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Belgium, France, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase II: Overall Response Rate | The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR). Only patients with measurable disease (the presence of at least one measurable lesion) at baseline were included in the study. CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. | every 8 - 9 weeks until disease progression or a new lesion is identified | No |
Secondary | Phase I: Best Overall Response (BOR) | BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR or SD >= 24 weeks).CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for partial disease (PD). PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline. | every 8 - 9 weeks until disease progression or a new lesion is identified | No |
Secondary | Phase II: Progression Free Survival (PFS) | PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment. | every 8 - 9 weeks until disease progression or a new lesion is identified | Yes |
Secondary | Phase II: Overall Survival (OS) | Overall survival (OS) is defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS. | every 3 months until death | No |
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