A clinical trial of Everolimus in Combination with Trastuzumab and Paclitaxel, as First Line Therapy in Women with HER2 Positive Locally Advanced or Metastatic Breast Cancer

Phase 1

• Conditions: HER2+ locally advanced or metastatic breast cancer; MedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-006556-21-DE
• Lead Sponsor: ovartis Pharma Service AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-28
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 719

Inclusion Criteria

• 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

Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 595
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 124

Exclusion Criteria

• 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

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified