A study of everolimus plus exemestane versus everolimus versus capecitabine in postmenopausal women with ER+ ABC after recurrence or progression on non-steroidal aromatase inhibitor (NSAI)

A three-arm, randomized, open label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003757-28-BE

Enrollment

300

Registered

2013-01-24

Start date

2013-02-20

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Estrogen receptor positive locally advanced or metastatic breast cancer in postmenopausal women MedDRA version: 20.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864

Interventions

Trade Name: Afinitor Product Name: Everolimus Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: everolimus CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). - Measurable disease defined as at least one lesion = 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness = 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above. 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 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: -Patients who received more than one chemotherapy line. -Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis. - Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors. Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Secondary Objective: - To estimate the hazard ratio of PFS for everolimus plus exemestane versus capecitabine in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole - Overall survival - Overall response rate - Clinical benefit rate - Safety - Time to ECOG performance deterioration - Time to quality of life (QOL) deterioration;Main Objective: To estimate the hazard ratio of PFS for everolimus plus exemestane versus everolimus alone in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole;Primary end point(s): To estimate the hazard ratio of PFS for everolimus plus exemestane versus everolimus alone in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.;Timepoint(s) of evaluation of this end point: Estimated to occur 28 months after first patient randomized	—

Measure

Time frame

Secondary Objective: - To estimate the hazard ratio of PFS for everolimus plus exemestane versus capecitabine in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole - Overall survival - Overall response rate - Clinical benefit rate - Safety - Time to ECOG performance deterioration - Time to quality of life (QOL) deterioration;Main Objective: To estimate the hazard ratio of PFS for everolimus plus exemestane versus everolimus alone in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole;Primary end point(s): To estimate the hazard ratio of PFS for everolimus plus exemestane versus everolimus alone in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.;Timepoint(s) of evaluation of this end point: Estimated to occur 28 months after first patient randomized

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Secondary

Measure	Time frame
Secondary end point(s): - To evaluate the treatment groups with respect to Overall Survival - Overall response rate (ORR) ) based on the local radiologist/investigator's tumor assessment (RECIST 1.1) - Clinical Benefit Rate - Safety: Incidence of adverse events, serious adverse events, changes from baseline in vital signs and laboratory results (hematology, blood chemistry) - Changes in ECOG performance status - Change in quality of life scores over time;Timepoint(s) of evaluation of this end point: - Every 3 months following last treatment date - date of first disease progression or death - date of first disease progression or death - Every visit for approx. 8 months - Every 6 weeks for approx. 8 months - Every 6 weeks for approx. 8 months	—

Measure

Time frame

Secondary end point(s): - To evaluate the treatment groups with respect to Overall Survival - Overall response rate (ORR) ) based on the local radiologist/investigator's tumor assessment (RECIST 1.1) - Clinical Benefit Rate - Safety: Incidence of adverse events, serious adverse events, changes from baseline in vital signs and laboratory results (hematology, blood chemistry) - Changes in ECOG performance status - Change in quality of life scores over time;Timepoint(s) of evaluation of this end point: - Every 3 months following last treatment date - date of first disease progression or death - date of first disease progression or death - Every visit for approx. 8 months - Every 6 weeks for approx. 8 months - Every 6 weeks for approx. 8 months

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Countries

Argentina, Australia, Belgium, Brazil, Denmark, Egypt, Hungary, India, Ireland, Lebanon, Malaysia, Peru, Russian Federation, Saudi Arabia, Spain, Sweden, Thailand, Turkey, United Kingdom, United States

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

clinicaltrial.enquiries@novartis.com41613241111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026