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Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (SOFT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Breast International Group
Cancer and Leukemia Group B
National Cancer Institute (NCI)
NSABP Foundation Inc
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00066690
First received: August 6, 2003
Last updated: July 29, 2016
Last verified: July 2016
Results First Received: July 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Estrogen Receptor Positive Breast Cancer
Progesterone Receptor Positive Tumor
Recurrent Breast Carcinoma
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Interventions: Drug: Exemestane
Other: Laboratory Biomarker Analysis
Procedure: Oophorectomy
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Tamoxifen
Drug: Triptorelin

  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
3066 patients were randomized between 17Dec03 and 27Jan11 at 426 centers in 25 countries.

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
Tamoxifen Tamoxifen 20mg orally daily for 5 years
T+OFS Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
E+OFS Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

Participant Flow:   Overall Study
    Tamoxifen     T+OFS     E+OFS  
STARTED     1021     1024     1021  
COMPLETED     423     502     457  
NOT COMPLETED     598     522     564  
Adverse Event                 145                 58                 126  
Death                 3                 0                 2  
Lack of Efficacy                 114                 110                 76  
Lost to Follow-up                 40                 21                 29  
Withdrawal by Subject                 50                 55                 49  
Treatment Ongoing                 246                 278                 282  



  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.
Intention-to-treat population, excludes 19 patients who immediately withdrew consent.

Reporting Groups
  Description
Tamoxifen Tamoxifen 20mg orally daily for 5 years
T+OFS Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
E+OFS Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Total Total of all reporting groups

Baseline Measures
    Tamoxifen     T+OFS     E+OFS     Total  
Number of Participants  
[units: participants]
  1018     1015     1014     3047  
Age  
[units: years]
Median (Inter-Quartile Range)
  43  
  (38 to 46)  
  43  
  (38 to 47)  
  43  
  (38 to 47)  
  43  
  (38 to 47)  
Gender [1]
[units: percent of participants]
       
Female     100     100     100     300  
Male     0     0     0     0  
Lymph-node status [1]
[units: percent of participants]
       
Negative     65.03     65.22     66.17     196.42  
Positive     34.97     34.78     33.83     103.58  
Tumor size [1]
[units: percent of participants]
       
Unknown     2.65     2.46     2.07     7.18  
<=2 cm     66.40     64.63     66.86     197.89  
>2cm     30.94     32.91     31.07     94.92  
Tumor grade [2]
[units: percent of participants]
       
Unknown     2.36     2.36     2.17     6.89  
1     27.01     26.11     24.36     77.48  
2     48.33     50.64     53.65     152.62  
3     22.30     20.89     19.82     63.01  
HER2-status [1]
[units: percent of participants]
       
Unknown     4.32     2.86     2.66     9.84  
Negative     84.18     85.42     84.52     254.12  
Positive     11.49     11.72     12.82     36.03  
[1] Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
[2]

Tumor grade is the histologic grade according to the BRE method. The method involves assessment of tumor morphology, including tubule formation, nuclear pleomorphism and frequency of mitoses. Grades are recorded according to criteria as 1,2 or 3. Grade 3 is associated with poor prognosis.

Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.




  Outcome Measures
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1.  Primary:   Disease-free Survival   [ Time Frame: 5-year estimates, reported at a median follow-up of 67 months. ]

2.  Secondary:   Breast Cancer-free Interval   [ Time Frame: 5-year estimates, reported at a median follow-up of 67 months. ]

3.  Secondary:   Distant Recurrence-free Interval   [ Time Frame: 5-year estimates, reported at a median follow-up of 67 months. ]

4.  Secondary:   Overall Survival   [ Time Frame: 5-year estimates ]
Results not yet reported.   Anticipated Reporting Date:   06/2017   Safety Issue:   No


  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
No text entered.


  More Information
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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: Rudolf Maibach, Executive Officer for International Trial Activities
Organization: IBCSG
phone: +41 31 389 91 96
e-mail: rudolf.maibach@ibcsg.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00066690     History of Changes
Obsolete Identifiers: NCT00917969, NCT02140190
Other Study ID Numbers: IBCSG 24-02
NCI-2009-01086 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000316456
BIG 2-02
2004-000166-13
IBCSG-24-02 ( Other Identifier: CTEP )
N02CM62212 ( US NIH Grant/Contract Award Number )
U24CA075362 ( US NIH Grant/Contract Award Number )
Study First Received: August 6, 2003
Results First Received: July 14, 2015
Last Updated: July 29, 2016
Health Authority: United States: Institutional Review Board