Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier:
NCT00201851
First received: September 12, 2005
Last updated: April 13, 2015
Last verified: April 2015
Results First Received: March 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Tamoxifen
Procedure: Surgery: Oophorectomy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
A - Scheduled Surgery

Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen

Tamoxifen: 20 mg po daily x 5 years

Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

B - Immediate Surgery

Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen

Tamoxifen: 20 mg po daily x 5 years

Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

C- Immediate Surgery - Nonrandomized

Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization

Tamoxifen: 20 mg po daily x 5 years

Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)


Participant Flow:   Overall Study
    A - Scheduled Surgery     B - Immediate Surgery     C- Immediate Surgery - Nonrandomized  
STARTED     252     257     231  
COMPLETED     244     255     230  
NOT COMPLETED     8     2     1  
Lost to Follow-up                 2                 1                 0  
Ineligible post enrollment                 6                 1                 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.
Baseline measures were not available on all participants.

Reporting Groups
  Description
A - Scheduled Surgery

Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen

Tamoxifen: 20 mg po daily x 5 years

Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

B - Immediate Surgery

Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen

Tamoxifen: 20 mg po daily x 5 years

Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

C- Immediate Surgery - Nonrandomized

Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization

Tamoxifen: 20 mg po daily x 5 years

Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)

Total Total of all reporting groups

Baseline Measures
    A - Scheduled Surgery     B - Immediate Surgery     C- Immediate Surgery - Nonrandomized     Total  
Number of Participants  
[units: participants]
  244     255     230     729  
Age  
[units: years]
Mean (Standard Deviation)
  42.2  (4.5)     42.3  (4.7)     42.1  (4.4)     42.2  (4.5)  
Gender  
[units: participants]
       
Female     244     255     230     729  
Male     0     0     0     0  
Estrogen receptor status  
[units: participants]
       
Positive     226     235     217     678  
Negative     16     19     13     48  
Progesterone receptor status  
[units: participants]
       
Positive     218     234     219     671  
Negative     25     20     11     56  
HER2/Neu status  
[units: participants]
       
Positive     41     45     32     118  
Negative     146     160     153     459  
Number of positive axillary nodes  
[units: participants]
       
None     96     111     103     310  
1-3     60     73     56     189  
4+     81     70     68     219  
Pathologic tumor size  
[units: cm]
Mean (Standard Deviation)
  4.5  (2.8)     4.7  (3.2)     4.1  (2.3)     4.5  (2.8)  
Progesterone level on day of surgery (ng/ml)  
[units: participants]
       
<2     75     158     74     307  
2-4.99     27     22     24     73  
5+     118     57     117     292  



  Outcome Measures

1.  Primary:   Disease-free Survival   [ Time Frame: two- to three-year accrual and initial two or more years of follow-up period ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Richard R. Love
Organization: International Breast Cancer Research Foundation
phone: 608-698-7881
e-mail: richardibcrf@gmail.com



Responsible Party: International Breast Cancer Research Foundation
ClinicalTrials.gov Identifier: NCT00201851     History of Changes
Other Study ID Numbers: OSU-0483
Study First Received: September 12, 2005
Results First Received: March 31, 2015
Last Updated: April 13, 2015
Health Authority: United States: Institutional Review Board