Clinical Trials /

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

NCT03176238

Description:

The present international, multi-center, open-label, single-arm study aims at collecting clinical safety, tolerability and efficacy data with the use of everolimus combined with exemestane in the Novartis Oncology Emerging Growth Market (EGM) countries for the treatment of post-menopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitor (NSAI) therapy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
  • Official Title: A Phase IIIb, Multi-center, Open-label Study of RAD001 in Combination With EXemestane in Post-menopausal Women With EStrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: CRAD001JIC06
  • NCT ID: NCT03176238

Conditions

  • Post Menopausal Breast Cancer

Interventions

DrugSynonymsArms
everolimusRAD001everolimus and exemestane
exemestaneeverolimus and exemestane

Purpose

The present international, multi-center, open-label, single-arm study aims at collecting clinical safety, tolerability and efficacy data with the use of everolimus combined with exemestane in the Novartis Oncology Emerging Growth Market (EGM) countries for the treatment of post-menopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitor (NSAI) therapy.

Trial Arms

NameTypeDescriptionInterventions
everolimus and exemestaneExperimentalEverolimus (RAD001) and exemestane combination
  • everolimus
  • exemestane

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:

          -  At least one lesion that can be 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.

        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 contains 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 is not required.

          -  Patient 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment emergent adverse events (Safety and tolerability)
Time Frame:Up to 5 years (Baseline, regularly scheduled visits up to last patient las visit)
Safety Issue:
Description:(AEs) by grade (CTCAE, version 4.03), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying as AEs.

Secondary Outcome Measures

Measure:Objective Response Rate
Time Frame:Up to 5 years (Baseline, regularly scheduled visits up to last patient last visit)
Safety Issue:
Description:Objective Response Rate (ORR) is defined as a best overall response of either complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) (version 1.1)
Measure:Progression Free Survival rate
Time Frame:Up to 5 years (Baseline, regularly scheduled visits up to last patient last visit)
Safety Issue:
Description:Progression Free Survival rate (PFS) is defined as the proportion of patients who have not had any documented progression or death due to any cause, according to Response Evaluation Criteria In Solid Tumors (RECIST) (version 1.1).
Measure:Clinical Benefit Rate
Time Frame:Up to 5 years (Baseline, regularly scheduled visits up to last patient last visit)
Safety Issue:
Description:Clinical Benefit Rate (CBR) rate is defined as the proportion of patients with best overall response of complete response (CR), partial response (PR) or stable disease (SD), with duration of 24 weeks or longer, according to Response Evaluation Criteria In Solid Tumors (RECIST) (version 1.1)
Measure:Changes from baseline in ECOG performance status
Time Frame:Up to 5 years (Baseline, regularly scheduled visits up to last patient last visit)
Safety Issue:
Description:Changes from baseline in ECOG performance status will be described. Time to deterioration of ECOG performance status, from baseline will be assessed using the ECOG Performance Status Scale (Oken, 1982)

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • post menopausal
  • advanced breast cancer
  • metastatic breast cancer
  • everolimus
  • exemestane
  • mTor inhibitor
  • endocrine therapy

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