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

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Hormone Receptor Positive Tumor; Early-Stage Breast Carcinoma

Treatments: Drug: Abemaciclib; Drug: Anastrozole; Drug: Loperamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02441946

I3Y-MC-JPBY (Other Identifier)

15805

2014-005486-75 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 3 patient groups

Abemaciclib + Anastrozole

Experimental group

Description:

Abemaciclib (150 milligrams \[mg\]) was given orally every 12 hours (Q12H) plus anastrozole (1 mg) orally once daily (QD) for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.

Treatment:

Drug: Anastrozole

Drug: Loperamide

Drug: Abemaciclib

Abemaciclib

Experimental group

Description:

Abemaciclib (150 mg) was given orally Q12H for 2 weeks. Loperamide was given as a prophylaxis for 4 weeks and then at physician discretion. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Total treatment duration was 16 weeks.

Treatment:

Drug: Anastrozole

Drug: Loperamide

Drug: Abemaciclib

Anastrozole

Active Comparator group

Description:

Anastrozole (1 mg) is given orally QD for 2 weeks. All participants received abemaciclib (150 mg) orally Q12H plus anastrozole (1 mg) QD for an additional 14 weeks. Loperamide was given as a prophylaxis for the first 2 weeks of the combination treatment and then at physician discretion. Total treatment duration was 16 weeks.

Treatment:

Drug: Anastrozole

Drug: Loperamide

Drug: Abemaciclib