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

Primary Purpose

Estrogen Receptor Positive, HER2/Neu Negative, Recurrent Breast Carcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Akt Inhibitor MK2206
Anastrozole
Goserelin Acetate
Laboratory Biomarker Analysis
Neoadjuvant Therapy
Pharmacological Study
Therapeutic Conventional Surgery
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Estrogen Receptor Positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • NOTE: breastfeeding should be discontinued if the mother is treated with MK-2206; women of childbearing potential 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
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy; NOTE: HIV-positive patients on combination antiretroviral therapy are ineligible; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
  • Evidence of inflammatory cancer (clinical presentation of skin erythema involving more than one third of the breast or pathological evidence of dermal lymphatic involvement)
  • Patients with known metastatic disease are excluded
  • Current use of therapeutic anticoagulation therapy
  • Previous excisional biopsy of the breast cancer
  • Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption) that impairs patients ability to swallow MK-2206 tablets

Sites / Locations

  • Mayo Clinic in Arizona
  • University of Chicago Comprehensive Cancer Center
  • University of Iowa/Holden Comprehensive Cancer Center
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Mayo Clinic
  • Metro Minnesota Community Oncology Research Consortium
  • Washington University School of Medicine
  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (MK2206, anastrozole, goserelin acetate)

Arm Description

Patients receive Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; anastrozole PO daily on days 1-28; and 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.

Outcomes

Primary Outcome Measures

Pathological Complete Response Rate
Any woman whose Ki67 value ≤10% on cycle 1 day 17 of combination treatment who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pathological complete response (pCR). A ninety percent confidence interval for the true pathologic complete response rate will be calculated using the Duffy-Santer approach.

Secondary Outcome Measures

Clinical Response Rate
The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on physical examination divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.
Incidence of Adverse Events, Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. For this endpoint, we are reporting the number of patients that reported a grade 3 or higher graded adverse event during neoadjuvent treatment. A complete list of all reported adverse events is in the Adverse Events section of the report.
Radiological Response Rate
The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on radiographic evaluation (mammogram or ultrasound) divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.

Full Information

First Posted
January 23, 2013
Last Updated
April 6, 2018
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01776008
Brief Title
Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
Official Title
A Phase II Trial of Neoadjuvant MK-2206 in Combination With Either Anastrozole if Postmenopausal or Anastrozole and Goserelin if Premenopausal in Women With Clinical Stage 2 or 3 PIK3CA Mutant Estrogen Receptor Positive and HER2 Negative Invasive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Study did not pass Stage 1 interim analysis.
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 5, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the pathologic complete response (pCR) rate of neoadjuvant MK-2206 (Akt inhibitor MK-2206) in combination with anastrozole (goserelin [goserelin acetate] is added if premenopausal) in women with clinical stage II or III phosphatidlinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutated estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)- breast cancer. SECONDARY OBJECTIVES: I. To determine the safety profile of neoadjuvant MK-2206 in combination with anastrozole (goserelin is added if premenopausal) in women with clinical stage II or III PIK3CA mutated ER+/HER2- breast cancer. II. To estimate the rate of clinical response and radiologic response using the World Health Organization (WHO) criteria. TERTIARY OBJECTIVES: I. For pre and post-menopausal women separately, to examine serum estradiol levels prior to pre-registration, prior to registration, after 2 cycles of anastrozole plus MK-2206 (cycle 3 day 1) and pre surgery. II. To examine the percent change in the apoptotic index after 2 weeks of combination therapy with MK-2206 and anastrozole (cycle 1 day 17) relative to apoptotic index after 4 weeks of treatment with anastrozole alone (pre MK-2206). III. To examine the change in Ki67 levels after 2 weeks of combination therapy with MK-2206 and anastrozole (cycle 1 day 17) relative to that after 4 weeks of treatment with anastrozole alone (pre MK-2206). IV. To estimate the proportion of patients whose Ki67 values is at most 10% after 2 weeks of combination therapy with MK-2206 and anastrozole (cycle 1 day 17) among those whose Ki67 was more than 10% or more after 4 weeks of treatment with anastrozole alone (pre MK-2206). V. To examine the pharmacodynamic effect of MK-2206 in combination with anastrozole (or anastrozole in combination with goserelin) on PI3K pathway signaling using serially collected tumor specimens. VI. To explore molecular mechanisms which could affect tumor response to combination MK-2206 and anastrozole (or anastrozole in combination with goserelin) in PIK3CA mutant ER+ breast cancer. VII. To examine the PIK3CA mutation status in circulating plasma deoxyribonucleic acid (DNA) prior to and following therapy on serially collected peripheral blood (pre anastrozole, pre MK-2206, cycle 1 day 17, and at the time of surgery) and to correlate with tumor tissue PIK3CA status. VIII. To examine PIK3CA mutation status of the residual cancer collected at the time of surgery post 4 cycles of neoadjuvant MK-2206 and anastrozole. OUTLINE: Patients receive Akt inhibitor MK-2206 orally (PO) on days 2, 9, 16, and 23; anastrozole PO daily on days 1-28; and goserelin acetate subcutaneously (SC) on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Standard of care surgery (breast and axillary lymph node surgery) is performed 1-3 weeks following the last dose of Akt inhibitor MK-2206. After completion of study treatment, patients are followed up for 30-60 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (MK2206, anastrozole, goserelin acetate)
Arm Type
Experimental
Arm Description
Patients receive Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; anastrozole PO daily on days 1-28; and 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.
Intervention Type
Drug
Intervention Name(s)
Akt Inhibitor MK2206
Other Intervention Name(s)
MK2206
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Other Intervention Name(s)
Anastrazole, Arimidex, ICI D1033, ICI-D1033, ZD-1033
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Goserelin Acetate
Other Intervention Name(s)
ZDX, Zoladex
Intervention Description
Given SC
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Neoadjuvant Therapy
Other Intervention Name(s)
Induction Therapy, Neoadjuvant, Preoperative Therapy
Intervention Description
Given before standard-care surgery
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo standard-care surgery
Primary Outcome Measure Information:
Title
Pathological Complete Response Rate
Description
Any woman whose Ki67 value ≤10% on cycle 1 day 17 of combination treatment who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pathological complete response (pCR). A ninety percent confidence interval for the true pathologic complete response rate will be calculated using the Duffy-Santer approach.
Time Frame
At time of surgery (up to 3 weeks after 4, 28-day cycles)
Secondary Outcome Measure Information:
Title
Clinical Response Rate
Description
The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on physical examination divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.
Time Frame
Baseline to end of Cycle 4 (28 day cycles)
Title
Incidence of Adverse Events, Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Description
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. For this endpoint, we are reporting the number of patients that reported a grade 3 or higher graded adverse event during neoadjuvent treatment. A complete list of all reported adverse events is in the Adverse Events section of the report.
Time Frame
Baseline to end of Cycle 4 (28 day cycles)
Title
Radiological Response Rate
Description
The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on radiographic evaluation (mammogram or ultrasound) divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.
Time Frame
Baseline and completion of cycle 4 (28 day cycles)
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
Proportion of Patients Whose Ki67 Values is at Most 10%
Description
A 95% binomial confidence intervals will be constructed for the true proportion of patients whose pre Akt inhibitor MK2206 ki67 value is at most 10% as well as for the true proportion of patients with a C1D17 Ki67 value that is at most 10% among those patients whose pre Akt inhibitor MK2206 Ki67 was more than 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
Title
Serum Estradiol Levels
Time Frame
At baseline, following 4 weeks of anastrozole alone, day 1 of course 3, and at pre-surgery
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 NOTE: breastfeeding should be discontinued if the mother is treated with MK-2206; women of childbearing potential 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 Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy; NOTE: HIV-positive patients on combination antiretroviral therapy are ineligible; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy Evidence of inflammatory cancer (clinical presentation of skin erythema involving more than one third of the breast or pathological evidence of dermal lymphatic involvement) Patients with known metastatic disease are excluded Current use of therapeutic anticoagulation therapy Previous excisional biopsy of the breast cancer Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption) that impairs patients ability to swallow MK-2206 tablets
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Ma
Organizational Affiliation
Mayo Clinic Cancer Center P2C
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Metro Minnesota Community Oncology Research Consortium
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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