MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This phase II trial is studies how well Akt inhibitor MK2206 works in treating patients with stage I-III breast cancer that can be removed by surgery. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Patients must have histologically-confirmed operable invasive breast cancer and have undergone core needle biopsy with an anticipated surgical resection for residual disease after enrollment

• Patients must have clinical stage I-III invasive breast (invasive tumor must be clinically at least >= T1c by radiograph or palpation)

• Patients must have available tissue from core biopsies for biomarker assessment; it is recommended that at least 4 cores be performed with 12 gauge (or smaller gauge) needles; this includes cores underneath ultrasound-guidance

• Patients are planning to undergo surgical treatment with either segmental resection or total mastectomy (required: 2 doses of weekly MK-2206 prior to surgery; the first dose will be at day -9 [+/- 1 day] and second dose at day -2 [+/- 1 day] in relation to surgery [day 0])

• Patients may have a history of contralateral breast cancer, provided there is no evidence of recurrence of the initial primary breast cancer

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky >= 80%)

• Leukocytes >= 3,000/ul within 28 days of registration

• Platelets >= 100,000 /uL within 28 days of registration

• Hemoglobin (Hgb) >= 9 g/dL within 28 days of registration

• Creatinine =< 1.5 x upper limit of normal (ULN) within 28 days of registration

• Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.2 x ULN within 28 days of registration

• Total bilirubin =< 1.5 x ULN within 28 days of registration

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN within 28 days of registration

• Patients of childbearing potential must have a negative serum or urine pregnancy test beta-human chorionic gonadotropin (β-hCG) within 72 hours prior to receiving the first dose of study medication

• Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately

• Patient must be able to swallow oral tablets

• Ability to understand and the willingness to sign a written informed consent document

• Patients must agree to biomarker assessment of pre-treatment diagnostic core biopsy tissue and the surgical resection tissue (i.e. excision or mastectomy); also, must agree to pre- and post-treatment fasting blood biomarker collection

Exclusion Criteria:

• Patients may not have any known evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases) or locally recurrent breast cancer

• Patients with inflammatory breast cancer are not eligible

• Patients with prior chemotherapy or radiation therapy within 6 months of study entry are not eligible (i.e. patient who have received neoadjuvant therapy are not eligible)

• Patients may not be receiving any other investigational agents, including other inhibitors of PI3K, Akt, or mammalian target of rapamycin (mTOR)

• Men diagnosed with breast cancer

• Patients may not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 used in the study

• Patients with known diabetes which is poorly controlled diabetes (hemoglobin A1c [HBA1C] >= 8%) should be excluded; if patient is taking metformin, must have been taking this medication for > 3 months, as metformin is thought to impact PI3K/Akt signaling

• Baseline corrected QT interval (QTc) > 470 msec will exclude patients from entry on study; patients with a baseline bundle branch block will be excluded

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MK2206

• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible