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

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ClinicalTrials.gov Identifier: NCT01776008
Recruitment Status : Terminated (Study did not pass Stage 1 interim analysis.)
First Posted : January 25, 2013
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: 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
Interventions: Drug: Akt Inhibitor MK2206
Drug: Anastrozole
Drug: Goserelin Acetate
Other: Laboratory Biomarker Analysis
Procedure: Neoadjuvant Therapy
Other: Pharmacological Study
Procedure: Therapeutic Conventional Surgery

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (MK2206, Anastrozole, Goserelin Acetate) Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (MK2206, Anastrozole, Goserelin Acetate)
STARTED   16 
COMPLETED   14 
NOT COMPLETED   2 
ineligible                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients registering were included in baseline description.

Reporting Groups
  Description
Treatment (MK2206, Anastrozole, Goserelin Acetate) Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Treatment (MK2206, Anastrozole, Goserelin Acetate) 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Median (Full Range)
 57.5 
 (40 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      16 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   16 


  Outcome Measures

1.  Primary:   Pathological Complete Response Rate   [ Time Frame: At time of surgery (up to 3 weeks after 4, 28-day cycles) ]

2.  Secondary:   Clinical Response Rate   [ Time Frame: Baseline to end of Cycle 4 (28 day cycles) ]

3.  Secondary:   Incidence of Adverse Events, Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: Baseline to end of Cycle 4 (28 day cycles) ]

4.  Secondary:   Radiological Response Rate   [ Time Frame: Baseline and completion of cycle 4 (28 day cycles) ]

5.  Other Pre-specified:   Change in Ki67 Levels   [ Time Frame: From 2 weeks of combination therapy with Akt inhibitor MK2206 and anastrozole (day 17 of course 1) to after 4 weeks of treatment with anastrozole alone ]

6.  Other Pre-specified:   Percent Change in the Apoptotic Index   [ Time Frame: From 2 weeks of combination therapy with Akt inhibitor MK2206 and anastrozole (day 17 of course 1) to after 4 weeks of treatment with anastrozole alone ]

7.  Other Pre-specified:   Proportion of Patients Whose Ki67 Values is at Most 10%   [ Time Frame: From 2 weeks of combination therapy with Akt inhibitor MK2206 and anastrozole (day 17 of course 1) to after 4 weeks of treatment with anastrozole alone ]

8.  Other Pre-specified:   Serum Estradiol Levels   [ Time Frame: At baseline, following 4 weeks of anastrozole alone, day 1 of course 3, and at pre-surgery ]

9.  Other Pre-specified:   The Pharmacodynamic Effect of Akt Inhibitor MK2206 in Combination With Anastrozole on the PI3K Pathway Activities, Assessed by Phosphoroproteomics and Immunohistochemistry Analysis on Serial Tumor Biopsies   [ Time Frame: Up to 3 weeks following the last dose of Akt inhibitor MK-2206 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cynthia Ma, M.D., Ph.D.
Organization: Washington University School of Medicine
e-mail: cma@dom.wustl.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01776008     History of Changes
Other Study ID Numbers: NCI-2013-00080
NCI-2013-00080 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1139
MC1139 ( Other Identifier: Mayo Clinic Cancer Center P2C )
9170 ( Other Identifier: CTEP )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM00099 ( U.S. NIH Grant/Contract )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: January 23, 2013
First Posted: January 25, 2013
Results First Submitted: September 7, 2017
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018