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Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (TEXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Breast International Group
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00066703
First received: August 6, 2003
Last updated: September 26, 2016
Last verified: September 2016
Results First Received: July 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: exemestane
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
2672 patients were randomized between 7Nov03 and 7Apr11 at 182 centers in 15 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
T+OFS Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
E+OFS Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

Participant Flow:   Overall Study
    T+OFS   E+OFS
STARTED   1334   1338 
COMPLETED   722   756 
NOT COMPLETED   612   582 
Adverse Event                80                111 
Death                3                0 
Lack of Efficacy                114                69 
Lost to Follow-up                31                28 
Withdrawal by Subject                38                63 
Treatment ongoing                346                311 



  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 12 patients who immediately withdrew consent, were at a non-adherent center, or had inadequate documentation of informed consent.

Reporting Groups
  Description
T+OFS Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
E+OFS Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Total Total of all reporting groups

Baseline Measures
   T+OFS   E+OFS   Total 
Overall Participants Analyzed 
[Units: Participants]
 1328   1332   2660 
Age 
[Units: Years]
Median (Inter-Quartile Range)
     
Age   44 
 (40 to 46) 
 43 
 (39 to 46) 
 43 
 (40 to 46) 
Gender 
[Units: Participants]
     
Female   1328   1332   2660 
Male   0   0   0 
Lymph-node status [1] 
[Units: Percent of participants]
     
Negative   52   52   104 
Positive   48   48   96 
[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.
Tumor size [1] 
[Units: Percent of participants]
     
<=2 cm   60   59   119 
>=2 cm   39   40   79 
unknown   1   1   2 
[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.
Tumor grade [1] 
[Units: Percent of participants]
     
 17   17   34 
 56   55   111 
 26   27   53 
unknown   1   1   2 
[1] 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.
HER2 status [1] 
[Units: Percent of participants]
     
Negative   87   87   174 
Positive   12   12   24 
Unknown   1   1   2 
[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.


  Outcome Measures
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1.  Primary:   Disease-free Survival   [ Time Frame: 5-year estimate reported at a median follow-up of 72 months ]

2.  Secondary:   Breast Cancer-free Interval   [ Time Frame: 5-year estimate reported at a median follow-up of 72 months ]

3.  Secondary:   Distant Recurrence-free Interval   [ Time Frame: 5-year estimates reported at a median follow-up of 72 months ]

4.  Secondary:   Overall Survival   [ Time Frame: 5-year estimates ]
Results not yet reported.   Anticipated Reporting Date:   12/2017   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 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: Rudolf Maibach, Executive Officer for International Trial Activities
Organization: IBCSG
phone: +41 31 389 91 96
e-mail: rudolf.maibach@ibcsg.org


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

Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00066703     History of Changes
Other Study ID Numbers: IBCSG 25-02 / BIG 3-02
IBCSG 25-02
BIG 3-02 ( Other Identifier: Breast International Group )
NABCI IBCSG 25-02
EU-20347
2004-000168-28 ( EudraCT Number )
CDR0000316458 ( Registry Identifier: CT.gov )
Study First Received: August 6, 2003
Results First Received: July 14, 2015
Last Updated: September 26, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil:
Egypt:
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India:
Italy: The Italian Medicines Agency
New Zealand:
Peru:
South Africa:
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency