Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with advanced breast cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Drug: Akt inhibitor MK2206
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Akt Inhibitor MK2206 in Patients With Advanced Breast Cancer Who Have Tumors With a PIK3CA Mutation and/or PTEN Loss|
- Response rate defined using RECIST version 1.1 [ Time Frame: Up to 3 weeks after completion of study treatment ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: from start of treatment to time of progression or death, whichever occurs first, assessed up to 3 weeks after completion of study treatment ] [ Designated as safety issue: No ]Kaplan-Meier estimates will be provided for each individual cohort.
- Cell proliferation as measured by the change in percent Ki-67 positive cells [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
- Apoptosis assessed by cleaved caspase 3 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Akt inhibitor MK2206)
Patients receive Akt Inhibitor MK-2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Akt inhibitor MK2206
Other Name: MK2206Other: laboratory biomarker analysis
I. To determine whether Akt inhibitor MK2206 achieves objective tumor responses (CR, PR) in advanced breast cancer patients who have a PIK3CA or Akt mutation and/or PTEN loss or mutation.
I. To determine the 6 month progression-free survival on MK2206. II. To determine baseline molecular markers that may predict clinical outcome. III. To determine pharmacodynamic markers in blood and tumor tissue that may predict a decrease in Ki-67 and clinical outcome.
IV. To determine safety and tolerability of MK2206 in previously treated patients with advanced breast cancer.
V. To determine if decrease in Ki-67 at 2 weeks correlates with anti-tumor effect (CR, PR, or SD > 6 months).
VI. To determine concordance of PIK3CA and PTEN status between primary tumor and distant metastasis.
VII. To determine concordance of PIK3CA status of circulating free DNA and distant metastasis.
Patients receive Akt Inhibitor MK-2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 weeks.
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Gerburg M. Wulf 617-667-1910 Gwulf@bidmc.harvard.edu|
|Principal Investigator: Gerburg M. Wulf|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Nancy U. Lin 617-632-2335 email@example.com|
|Principal Investigator: Nancy U. Lin|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Matthew Mauerer 212-851-4761 firstname.lastname@example.org|
|Principal Investigator: Matthew Mauerer|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Contact: Vandana G. Abramson 615-936-8422 email@example.com|
|Principal Investigator: Vandana G. Abramson|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Funda Meric-Bernstam 713-745-0398 firstname.lastname@example.org|
|Principal Investigator: Funda Meric-Bernstam|
|Principal Investigator:||Funda Meric-Bernstam||M.D. Anderson Cancer Center|