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Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265759
First Posted: December 15, 2005
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: February 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: anastrozole
Drug: exemestane
Drug: letrozole
Procedure: Therapeutic Conventional Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Z1031A enrolled postmenopausal women with stage II/III ER+ (Allred 6 to 8) breast cancer (BC) whose treatment was randomized to neoadjuvant AI therapy with anastrozole, exemestane or letrozole. For Z1031B the protocol was amended to include a tumor Ki67 determination after 2-4 weeks of AI.

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
Cohort A Arm I: Exemestane Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
Cohort A Arm II: Letrozole Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
Cohort A Arm III: Anastrozole Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
Cohort B Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.

Participant Flow:   Overall Study
    Cohort A Arm I: Exemestane   Cohort A Arm II: Letrozole   Cohort A Arm III: Anastrozole   Cohort B
STARTED   124   128   125   245 
COMPLETED   124   127   123   236 
NOT COMPLETED   0   1   2   9 
Withdrawal by Subject                0                1                2                2 
Cancel                0                0                0                3 
Ineligible                0                0                0                1 
Bilateral disease                0                0                0                2 
Discontinued due to intolerability                0                0                0                1 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Cohort A Arm I: Exemestane Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Cohort A Arm II: Letrozole Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Cohort A Arm III: Anastrozole Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Cohort B Arm I: Week 2 Ki67 <=10% Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
Cohort B Arm II: Week 2 Ki67 >10% Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
Cohort B Arm III: Week 2 Ki67 No Invasive Disease Present Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
Total Total of all reporting groups

Baseline Measures
   Cohort A Arm I: Exemestane   Cohort A Arm II: Letrozole   Cohort A Arm III: Anastrozole   Cohort B Arm I: Week 2 Ki67 <=10%   Cohort B Arm II: Week 2 Ki67 >10%   Cohort B Arm III: Week 2 Ki67 No Invasive Disease Present   Total 
Overall Participants Analyzed 
[Units: Participants]
 124   127   123   165   49   22   610 
Age 
[Units: Years]
Median (Full Range)
 69 
 (43 to 90) 
 65 
 (49 to 90) 
 65 
 (51 to 87) 
 65 
 (49 to 86) 
 60 
 (47 to 76) 
 66 
 (53 to 84) 
 65 
 (43 to 90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      124 100.0%      127 100.0%      123 100.0%      165 100.0%      49 100.0%      22 100.0%      610 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
             
United States   124   127   123   165   49   22   610 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Response (Complete or Partial Response) Rate (Cohort A)   [ Time Frame: Up to 18 weeks ]

2.  Primary:   Anti-tumor Effect in Terms of Pathologic CR (pCR) Rate to Neoadjuvant Chemotherapy (Cohort B)   [ Time Frame: Up to 18 weeks ]

3.  Secondary:   Toxicity (Cohort A)   [ Time Frame: Up to 30 days after drug therapy ]

4.  Secondary:   Rate of Improved Surgical Outcome for Patients Considered Marginal for Breast Conservation Surgery Prior to Therapy (Cohort A)   [ Time Frame: At time of surgery up to 18 weeks ]

5.  Secondary:   Rate of Downstaging to Stage I Determined by Sentinel Node Evaluation (Cohort A)   [ Time Frame: At time of surgery up to 18 weeks ]

6.  Secondary:   Rate of Lymph Node Involvement (LNI) (Cohort A)   [ Time Frame: At time of surgery up to 18 weeks ]

7.  Secondary:   The Pathologic Complete Response (pCR) Rate (Cohort A)   [ Time Frame: At time of surgery up to 18 weeks ]

8.  Secondary:   Clinical Response Rate (Cohort B)   [ Time Frame: Up to 18 weeks ]

9.  Secondary:   Rate of Improved Surgical Outcome for Patients Designated as Candidates for Mastectomy Prior to Therapy (Cohort A)   [ Time Frame: At time of surgery up to 18 weeks ]

10.  Secondary:   Progression-free Survival (PFS) (Cohort A and B)   [ Time Frame: assessed up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   08/2022  

11.  Secondary:   Overall Survival (Cohort A and B)   [ Time Frame: assessed up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   08/2022  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Matthew J. Ellis, MB, BChir, BSc., PhD, FRCP
Organization: Baylor College of Medicine
phone: 713 798-1999
e-mail: Matthew.Ellis@bcm.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00265759     History of Changes
Obsolete Identifiers: NCT00698971
Other Study ID Numbers: ACOSOG-Z1031
CDR0000456382 ( Registry Identifier: NCI Physician Data Query )
First Submitted: December 14, 2005
First Posted: December 15, 2005
Results First Submitted: February 14, 2017
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017