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A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer


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

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase l: To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity rate.

Outcome Time Frame:

at every critical DLT, after 6 patients have completed cycle 1 or every 2 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001J2101

NCT ID:

NCT00426556

Start Date:

July 2007

Completion Date:

June 2013

Related Keywords:

  • Metastatic Breast Cancer
  • Breast cancer
  • Cancer of the breast
  • Human mammary carcinoma
  • HER-2
  • Metastatic
  • everolimus
  • trastuzumab
  • paclitaxel
  • Breast Neoplasms

Name

Location

Sammons Cancer CenterDallas, Texas  
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)Atlanta, Georgia  30322
Cancer Centers of the Carolinas CC of C -EastsideGreenville, South Carolina  29605
Florida Cancer CareDavie, Florida  33328
Wilshire Oncology Medical Group La Verne*see Various Departments*, California  
North Shore University Health SystemSkokie, Illinois  60077
Loma Linda University Dept.ofLomaLindaCancerCent(3)Loma Linda, California  
Compassionate Cancer Care Medical Group Dept.ofCCCMGFountain Valley, California  92708
University of California at Los Angeles Dept.of UCLA Dept.ofMed.Los Angeles, California  90095
Peninsula Regional Medical Center Deptof Oncology and HematologySalisbury, Maryland  21801
Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CRAD001J2101St. Louis, Missouri  63110