A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

• Status: Completed
• Trial end date: 2018-02-12
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Anastrozole; Antidiarrheals; Hormones; Loperamide

Criteria

Inclusion Criteria:

• Have postmenopausal status.

• Adenocarcinoma of the breast.

• Breast tumor ≥1 centimeter (cm) in diameter, HR+, HER2-.

• Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.

• Primary breast cancer that is suitable for baseline core biopsy.

• Have adequate organ function.

Exclusion Criteria:

• Bilateral invasive breast cancer.

• Metastatic breast cancer (local spread to axillary lymph nodes is permitted).

• Inflammatory breast cancer.

• Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in the same breast as currently being treated.

• Prior radiotherapy to the ipsilateral chest wall for any malignancy.

• Prior anti-estrogen therapy.