A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor

• Status: Active, not recruiting
• Trial end date: 2022-04-29
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- ABC after recurrence or progression on letrozole or anastrozole.

The rationale of this study is based on the following:

• Proven everolimus activity in breast cancer in combination with exemestane

• Efficacy and manageable safety profile of everolimus in combination with exemestane in the Asian subpopulation of BOLERO-2

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Aromatase Inhibitors; Estrogens; Everolimus; Exemestane; Sirolimus

Criteria

Inclusion Criteria:

locally advanced, recurrent, or metastatic breast cancer. Locally advanced breast cancer must not be amenable to curative treatment by surgery or radiotherapy.

• Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer

• Postmenopausal women. Postmenopausal status is defined either by:

• Prior bilateral oophorectomy

• Or age ≥60

• Or age < 60 and amenorrhea for 12 or more months

• Recurrence or progression on prior NSAI is defined as:

• Recurrence while on, or within one year (12 months) of end of adjuvant treatment with letrozole or anastrozole OR

• Progression while on or within one month (30 days) of the end of prior treatment with letrozole or anastrozole

• Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrollment

• Patient must have as per RECIST 1.1

• measurable disease or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease.

8. Patient is able to swallow and retain oral medication 9. Patient must meet the hematologic & biochemistery laboratory values at the screening visit:

• Written informed consent must be obtained prior to any screening procedures

Exclusion Criteria:

• Patients eligible for this study must not meet any of the following criteria:

• HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive), based on the most recent test. Note: Patients with IHC 2+ must have a negative in situ hybridization test.

• Patients who received more than one chemotherapy line for ABC

• Patient with symptomatic visceral disease and is candidate to chemotherapy

• Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis (e.g. pleural effusion, ascites etc.)

• Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry except topical applications, inhaled sprays, eye drops or local injections.

• Uncontrolled diabetes mellitus as defined by HbA1c >7% despite adequate therapy.

Other protocol-defined inclusion/exclusion criteria may apply"