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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00426556
First received: January 23, 2007
Last updated: March 6, 2014
Last verified: March 2014

January 23, 2007
March 6, 2014
July 2007
June 2013   (final data collection date for primary outcome measure)
  • 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 ]
To establish the feasible dose levels/regimens based on end-of-cycle-1 dose limiting toxicity
Complete list of historical versions of study NCT00426556 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To assess the ability to deliver the trastuzumab and paclitaxel therapy
  • To assess everolimus, trastuzumab and paclitaxel blood levels in this combination
  • To evaluate the overall tumor response
Not Provided
Not Provided
 
Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
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.

Not Provided
Interventional
Phase 1
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: everolimus
10 mg daily
Experimental: Everolimus
Intervention: Drug: everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
June 2013
June 2013   (final data collection date for primary outcome measure)

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

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   France,   Netherlands,   Spain
 
NCT00426556
CRAD001J2101, 2006-001596-37
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP