Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00426556
First received: January 23, 2007
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: everolimus |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Phase l: To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity rate. [ Time Frame: at every critical DLT, after 6 patients have completed cycle 1 or every 2 months ] [ Designated as safety issue: Yes ]
- Phase II: To evaluate the efficacy of the dose/level regimen of RAD001 recommended from the phase I with trastuzumab and paclitaxel therapy. This will be based on the overall response rate. [ Time Frame: every 8 - 9 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Phase I : Assess ability to deliver trastuzumab and paclitaxel therapy based on the relative dose intensity of paclitaxel & on the discontinuation rate of trastuzumab, assess everolimus, trastuzumab & paclitaxel PK in a subset of patients [ Time Frame: every 8 - 9 weeks ] [ Designated as safety issue: No ]
- To evaluate progression free survival (PFS), overall survival(OS) and to describe the safety profile of the phase II part combination. [ Time Frame: every 8 - 9 weeks and for OS, every 3 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 134 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Everolimus |
Drug: everolimus
10 mg daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426556
Locations
| United States, California | |
| Wilshire Oncology Medical Group La Verne | |
| *see Various Departments*, California, United States | |
| Compassionate Cancer Care Medical Group Dept.ofCCCMG | |
| Fountain Valley, California, United States, 92708 | |
| Loma Linda University Dept.ofLomaLindaCancerCent(3) | |
| Loma Linda, California, United States, 92354 | |
| University of California at Los Angeles Dept.of UCLA Dept.ofMed. | |
| Los Angeles, California, United States, 90095 | |
| United States, Florida | |
| Florida Cancer Care | |
| Davie, Florida, United States, 33328 | |
| United States, Georgia | |
| Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| North Shore University Health System | |
| Evanston, Illinois, United States, 60201 | |
| United States, Maryland | |
| Peninsula Regional Medical Center Deptof Oncology and Hematology | |
| Salisbury, Maryland, United States, 21801 | |
| United States, Missouri | |
| Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CRAD001J2101 | |
| St. Louis, Missouri, United States, 63110 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas CC of C -Eastside | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Sammons Cancer Center | |
| Dallas, Texas, United States, 78246 | |
| Belgium | |
| Novartis Investigative Site | |
| Charleroi, Belgium, 6000 | |
| Novartis Investigative Site | |
| Liege, Belgium, 4000 | |
| Novartis Investigative Site | |
| Turnhout, Belgium, 2300 | |
| France | |
| Novartis Investigative Site | |
| Paris, France, 75970 | |
| Novartis Investigative Site | |
| Saint-Herblain Cédex, France, 44805 | |
| Novartis Investigative Site | |
| Toulouse Cedex 3, France, 31052 | |
| Novartis Investigative Site | |
| Villejuif Cedex, France, 94805 | |
| Netherlands | |
| Novartis Investigative Site | |
| Maastricht, Netherlands, 6229 HX | |
| Spain | |
| Novartis Investigative Site | |
| Lleida, Cataluña, Spain, 25198 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00426556 History of Changes |
| Other Study ID Numbers: | CRAD001J2101, 2006-001596-37 |
| Study First Received: | January 23, 2007 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration Belgium: Directorate general for the protection of Public health: Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Netherlands: Dutch Health Care Inspectorate Spain: Spanish Agency of Medicines |
Keywords provided by Novartis:
|
Breast cancer Cancer of the breast Human mammary carcinoma HER-2 |
Metastatic everolimus trastuzumab paclitaxel |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Everolimus Sirolimus Trastuzumab Paclitaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013