Status:
COMPLETED
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.
Eligibility Criteria
Inclusion
- Adult Women (≥ 18 years old).
- Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.
- Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.
- HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
- Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued \> 12 months prior to randomization.
- Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
- Documentation of negative pregnancy test.
- Organ functions at time of inclusion.
Exclusion
- Prior mTOR inhibitors for the treatment of cancer.
- Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.
- Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).
- Radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization
- History of central nervous system metastasis.
- Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.
- Serious peripheral neuropathy.
- Cardiac disease or dysfunction.
- Uncontrolled hypertension.
- HIV.
- Pregnant,
Key Trial Info
Start Date :
September 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2017
Estimated Enrollment :
719 Patients enrolled
Trial Details
Trial ID
NCT00876395
Start Date
September 10 2009
End Date
October 23 2017
Last Update
December 19 2018
Active Locations (140)
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1
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
Mobile, Alabama, United States, 36688
2
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
3
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
4
Comprehensive Blood and Cancer Center Dept. of CBCC (2)
Bakersfield, California, United States, 93309