Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Condition: Post Menopausal Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: everolimus; exemestane
Intervention description: one 10 mg tablet or two 5 mg tablets of everolimus were administered orally once daily on a continuous dosing schedule starting on Day 1; 25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1
Intervention MeSH terms: Everolimus; Exemestane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post menopausal; advanced breast cancer; metastatic breast cancer; everolimus; exemestane; mTor inhibitor; endocrine therapy; human epidermal growth factor; estrogen receptor positive; adult; CRAD001

Summary:

      This international, multi-center, open-label, single-arm study evaluated the safety and
      tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative
      locally advanced or metastatic breast cancer after documented recurrence or progression
      following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent
      growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to
      confirm no difference in safety and efficacy. Summary statistics were presented.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not
             amenable to curative treatment by surgery or radiotherapy.

          -  Histological or cytological confirmation of hormone-receptor positive (HR+) breast
             cancer.

          -  Disease refractory to non-steroidal aromatase inhibitors, defined as:

          -  Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy
             with letrozole or anastrozole, or

          -  Progression while on, or within one month (30 days) of completion of letrozole or
             anastrozole treatment for locally advanced or metastatic breast cancer (ABC).

          -  Radiological or objective evidence of recurrence or progression on or after the last
             systemic therapy prior to enrolment.

          -  Patients must have had:

          -  At least one lesion that could have been accurately measured in at least one dimension

               -  20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or

          -  Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as
             defined above.

          -  Adequate bone marrow, coagulation, liver and renal function.

          -  ECOG performance status ≤ 2.

        Exclusion Criteria:

          -  Patients overexpressing HER2 by local laboratory testing (IHC 3+ staining or in situ
             hybridization positive). Patients with IHC 2+ must have a negative in situ
             hybridization test.

          -  Patients with only non-measurable lesions other than bone metastasis (e.g. pleural
             effusion, ascites).

          -  Patients with more than one prior chemotherapy line for ABC. A chemotherapy line is an
             anticancer regimen(s) that contained at least 1 cytotoxic chemotherapy agent, given
             for a minimum of 21 days.

          -  Previous treatment with mTOR inhibitors.

          -  Known hypersensitivity to mTOR inhibitors, e.g. Sirolimus (rapamycin).

          -  Patients with a known history of HIV seropositivity. Screening for HIV infection at
             baseline was not required.

          -  Patient who were being treated with drugs recognized as being strong inhibitors or
             inducers of the isoenzyme CYP3A

          -  History of brain or other CNS metastases, including leptomeningeal metastasis.