Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer

Completed · Phase 2

Conditions studied: Estrogen Receptor Status, HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

In brief

This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.

Key facts

Study ID

NCT02860000

Run by

Mayo Clinic

People needed

96

Starts

2017-07-06

Expected to finish

2025-02-14

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• PRE-REGISTRATION ELIGIBILITY
• Post-menopausal defined as
• Age >= 60 and amenorrhea > 12 consecutive months, OR
• Age < 60 and amenorrhea > 12 consecutive months without another cause and documented follicle stimulating hormone (FSH) level of > 35 mIU/mL, OR
• Previous bilateral oophorectomy
• Histologic proof of metastatic or locally advanced, unresectable breast cancer
• History of ER positive (+) (>= 10% of cells positive on hematoxylin and eosin stain [H\&E]), HER2 negative (-) breast cancer disease, either as a
• History of primary, operable ER+/HER2- invasive breast cancer OR
• History of de novo metastatic breast cancer that is ER+/HER2-
• Note: HER2- (negative) disease defined as one of the following:
• HER2 immunohistochemistry (IHC) expression of 0, 1+ and in-situ hybridization (ISH) non-amplified
• HER2 IHC expression of 0, 1+ and ISH not done
• HER2 IHC expression of 2+ and ISH non-amplified
• IHC not done and ISH non-amplified
• Prior treatment
• No more than two prior chemotherapy regimens in the metastatic setting
• Prior treatment with fulvestrant in the metastatic setting is required, except for patients with a history of ER-negative metastatic breast cancer
• Unlimited prior endocrine therapy regimens in the metastatic setting are allowed
• No prior treatment with an aurora Kinase inhibitor (either an aurora A or pan-aurora kinase inhibitor)
• Disease that is measurable where:
• A non-nodal lesion is considered measurable if its longest diameter can be accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm with computed tomography (CT) scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI)
• A malignant lymph node is considered measurable if its short axis is >= 1.5 cm when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm); Note: tumor lesions in a previously irradiated area are not considered measurable disease; Note: disease that is measurable by physical examination only is not eligible
• No history of tumors involving spinal cord or heart
• History of brain metastases as per the following criteria:
• Patients with a history of resected brain metastases are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including < 28 days prior to pre-registration

You may not qualify if…

• REGISTRATION EXCLUSION CRITERIA
• Any of the following therapies prior to registration:
• Chemotherapy =< 21 days
• Immunotherapy =< 21 days
• Biologic therapy =< 21 days
• Hormonal therapy =< 14 days
• Monoclonal antibodies =< 14 days
• Radiation therapy =< 14 days
• Administration of myeloid growth factors or platelet transfusion =< 14 days prior to registration
• Systemic infection requiring intravenous (IV) antibiotic therapy =< 14 days prior to registration
• Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort =< 14 days prior to registration
• Receipt of corticosteroids =< 7 days prior to registration, unless patient has been taking a continuous dose of no more than 15 mg/day of prednisone for at least 30 days prior to registration

Where it is running

• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt Breast Center at One Hundred Oaks — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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