Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT00876395
Eligibility Criteria:
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.
* Organ functions at time of inclusion.
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,
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00876395
Study Brief:
Protocol Section:
NCT00876395