Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

• Status: Completed
• Trial end date: 2021-01-13
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to find out if combining everolimus with letrozole is safe and has beneficial effects in postmenopausal women who have estrogen positive HER2 negative locally advanced or metastatic breast cancer. Additionally, this study aims to find out if everolimus plus exemestane is safe and has beneficial effects in women with estrogen positive locally advanced or metastatic breast cancer after treatment with everolimus plus letrozole. This study will also aim to find out if a mouth rinse can help reduce the severity of oral stomatitis, a common side effect of everolimus. This part of the study will be conducted only in countries where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially available.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ethanol; Everolimus; Exemestane; Letrozole; Sirolimus

Criteria

Inclusion Criteria:

• Patients 18 years old or greater

• Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy

• Histological or cytological confirmation of estrogen-receptor positive (ER+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer

• Postmenopausal women

• No prior treatment for metastatic breast cancer

Exclusion Criteria:

• Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)

• Patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.

• Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.

• Previous treatment with mTOR inhibitors.

• Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).

• Other protocol-defined inclusion/exclusion criteria may apply