NCT02219789

Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery

A Phase I Trial to Evaluate the Safety of the Addition of Alisertib to Fulvestrant in Women With Advanced Hormone Receptor Positive (HR+) Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of alisertib when given together with fulvestrant in treating patients with hormone positive breast cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and cannot be removed by surgery. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and progesterone are type of hormones made by the body and they can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen or progesterone the body makes. Giving alisertib together with fulvestrant may be a better treatment for breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose of alisertib in combination with fulvestrant. SECONDARY OBJECTIVES: I. To describe the safety and tolerability of alisertib in combination with fulvestrant. II. To examine tumor response in postmenopausal women treated with alisertib in combination with fulvestrant. TERTIARY OBJECTIVES: I. To assess aurora A kinase expression in archived breast cancer tissue biospecimens of participants, and to describe levels in those who do or do not experience dose-limiting toxicities (DLTs) or objective response. OUTLINE: This is a dose-escalation study of alisertib. Patients receive fulvestrant intramuscularly (IM) on day 1 (days 1 and 15 of course 1 only) and alisertib orally (PO) twice daily (BID) on days 1-3, 8-10, and 15-17. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month.

Conditions

• Estrogen Receptor Positive
• Progesterone Receptor Positive
• Recurrent Breast Carcinoma
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	Alisertib	Given PO
DRUG	Fulvestrant	Given IM
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2014-12-05
• Primary completion: 2016-03-28
• Completion: 2018-10-01
• First posted: 2014-08-19
• Last updated: 2018-10-03

Locations

1 site across 1 country: United States