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Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer

This study has been terminated.
(Due to funding source and lack of accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01368263
First received: June 2, 2011
Last updated: March 16, 2015
Last verified: March 2015
Results First Received: January 23, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Estrogen Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Interventions: Drug: goserelin acetate
Drug: letrozole
Drug: anastrozole
Drug: chemotherapy
Procedure: 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
The study opened to participant accrual on 09/13/2011 and closed to participant accrual on 05/22/2013.

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
Group 1 (Ki67 <10%, E2 <= 15 pg/ml) Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml) Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
Group 3 (E2 > 15 pg/ml) Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.

Participant Flow:   Overall Study
    Group 1 (Ki67 <10%, E2 <= 15 pg/ml)     Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)     Group 3 (E2 > 15 pg/ml)  
STARTED     6     1     1  
COMPLETED     6     1     1  
NOT COMPLETED     0     0     0  



  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
Group 1 (Ki67 <10%, E2 <= 15 pg/ml) Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml) Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
Group 3 (E2 > 15 pg/ml) Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
Total Total of all reporting groups

Baseline Measures
    Group 1 (Ki67 <10%, E2 <= 15 pg/ml)     Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)     Group 3 (E2 > 15 pg/ml)     Total  
Number of Participants  
[units: participants]
  6     1     1     8  
Age  
[units: years]
Median (Full Range)
  43  
  (35 to 53)  
  29  
  (29 to 29)  
  35  
  (35 to 35)  
  38.5  
  (29 to 53)  
Gender  
[units: participants]
       
Female     6     1     1     8  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     6     1     1     8  



  Outcome Measures
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1.  Primary:   Pathologic Complete Response (CR) Rate   [ Time Frame: 1 month ]

2.  Primary:   Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy   [ Time Frame: 6 months post neoadjuvant endocrine therapy and surgery ]

3.  Secondary:   Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67   [ Time Frame: Baseline and 4 weeks post-treatment ]

4.  Secondary:   Preoperative Endocrine Prognostic Index Score (PEPI Score)   [ Time Frame: At time of definitive surgery ]

5.  Secondary:   PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less   [ Time Frame: 16 weeks ]


  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: Timothy Pluard, M.D.
Organization: Washington University School of Medicine
phone: 314-362-5645
e-mail: tpluard@saint-lukes.org



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01368263     History of Changes
Other Study ID Numbers: 201106141
Study First Received: June 2, 2011
Results First Received: January 23, 2015
Last Updated: March 16, 2015
Health Authority: United States: Institutional Review Board