Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer

Stopped early · Phase 2

Conditions studied: Estrogen Receptor Positive, HER2/Neu Negative, Recurrent Breast Carcinoma, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

In brief

This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving MK-2206, anastrozole, and goserelin acetate together may kill more tumor cells.

Key facts

Study ID

NCT01776008

Run by

National Cancer Institute (NCI)

People needed

16

Starts

2013-01-01

Expected to finish

2015-05-05

Last updated by the study team

2018-05-08

Who can join

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

You may qualify if…

• Clinical T2-T4c, any N, M0 invasive ER+ (Allred score of 6-8) and HER2 negative (0 or 1+ by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH] negative for amplification) breast cancer, by American Joint Committee on Cancer (AJCC) 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node;
• Note: if the patient has invasive or ductal carcinoma in situ (DCIS) in the contralateral breast the patient is not eligible for this study
• >= 1 measurable lesion that is palpable, its size can be measured by bi-dimensional tape, ruler or caliper technique, and the minimum size of the largest tumor diameter is greater than 2.0 cm by imaging or physical examination
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Life expectancy > 4 months
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin =< upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN
• Creatinine =< ULN OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine above institutional normal
• Patient with diabetes mellitus: fasting glucose =< 120 mg/dL and hemoglobin A1c (HbA1c) =< 8%
• Negative serum pregnancy test =< 7 days prior to pre-registration for women of childbearing potential
• Ability to understand and the willingness to sign a written informed consent document
• Patient is postmenopausal or premenopausal
• NOTE: postmenopausal women, verified by
• Bilateral surgical oophorectomy, or
• No spontaneous menses >= 1 year or
• No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards or
• Premenopausal women, verified by:
• Regular menses or
• FSH and estradiol levels in premenopausal range, according to institutional standards
• Willingness to provide biologic samples for PIK3CA sequencing and correlative studies
• Positive for PIK3CA mutation based on central laboratory testing
• In premenopausal women, serum estradiol level in postmenopausal range =< 7 days prior to registration

You may not qualify if…

• Any of the following for treatment of this cancer including:
• Surgery
• Radiation therapy
• Chemotherapy
• Biotherapy
• Hormonal therapy
• Investigational agent prior to study entry
• Receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in this study
• Prior axillary lymph node sampling (sentinel lymph node biopsy or axillary lymph node dissection); NOTE: fine needle aspiration (FNA) of axillary lymph node is acceptable
• Invasive cancer or DCIS in the contralateral breast
• Receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP450 3A4);
• NOTE: oxidative metabolism of MK-2206 in human liver microsomes is catalyzed primarily by CYP3A4, although direct glucuronidation also occurs; at least 7 days washout period is required in patients who were previously taking strong inhibitors or inducers of CYP.450 3A4; patients who are currently taking moderate inhibitors or inducers of CYP450 3A4 are encouraged to switch to other medications that do not interact with CYP450 3A4
• Corrected QT interval (QTc) prolongation (defined as a QTc interval > 480 msec) or other significant electrocardiogram (ECG) abnormalities
• Receiving any medications or substances with risk of torsades de pointes; Note: medications or substances on the list "Drugs with Risk of Torsades de Pointes" are prohibited; medications or substances on the list "Drugs with Possible or Conditional Risk of Torsades de Pointes" may be used while on study with extreme caution and careful monitoring
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Uncontrolled symptomatic cardiac arrhythmia
• Psychiatric illness/social situations that would limit compliance with study requirements
• Any of the following:
• Pregnant women
• Nursing women
• Women of childbearing potential who are unwilling to employ adequate contraception

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Metro Minnesota Community Oncology Research Consortium — Saint Louis Park, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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