Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (TEXT)
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| ClinicalTrials.gov Identifier: NCT00066703 |
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Recruitment Status :
Active, not recruiting
First Posted : August 7, 2003
Results First Posted : April 5, 2016
Last Update Posted : January 2, 2024
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Sponsor:
ETOP IBCSG Partners Foundation
Collaborators:
National Cancer Institute (NCI)
Breast International Group
Information provided by (Responsible Party):
ETOP IBCSG Partners Foundation
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Breast Cancer |
| Interventions |
Drug: exemestane Drug: tamoxifen Drug: triptorelin |
| Enrollment | 2672 |
Participant Flow
| Recruitment Details | 2672 patients were randomized between 7Nov03 and 7Apr11 at 182 centers in 15 countries. |
| Pre-assignment Details |
| Arm/Group Title | T+OFS | E+OFS |
|---|---|---|
 Arm/Group Description |
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. | 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. |
| Period Title: Overall Study | ||
| Started | 1334 | 1338 |
| Completed | 722 | 756 |
| Not Completed | 612 | 582 |
| Reason Not Completed | ||
| 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
| Arm/Group Title | T+OFS | E+OFS | Total | |
|---|---|---|---|---|
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Arm/Group Description |
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. | 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 of all reporting groups | |
| Overall Number of Baseline Participants | 1328 | 1332 | 2660 | |
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Baseline Analysis Population Description |
Intention-to-treat population excludes 12 patients who immediately withdrew consent, were at a non-adherent center, or had inadequate documentation of informed consent.
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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| Age | Number Analyzed | 1328 participants | 1332 participants | 2660 participants |
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44
(40 to 46)
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43
(39 to 46)
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43
(40 to 46)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 1328 participants | 1332 participants | 2660 participants | |
| Female |
1328 100.0%
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1332 100.0%
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2660 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Lymph-node status
[1] Measure Type: Number Unit of measure: Percent of participants |
Number Analyzed | 1328 participants | 1332 participants | 2660 participants |
| Negative | 52 | 52 | 104 | |
| Positive | 48 | 48 | 96 | |
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[1]
Measure Description: 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.
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Tumor size
[1] Measure Type: Number Unit of measure: Percent of participants |
Number Analyzed | 1328 participants | 1332 participants | 2660 participants |
| <=2 cm | 60 | 59 | 119 | |
| >=2 cm | 39 | 40 | 79 | |
| unknown | 1 | 1 | 2 | |
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[1]
Measure Description: 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.
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Tumor grade
[1] Measure Type: Number Unit of measure: Percent of participants |
Number Analyzed | 1328 participants | 1332 participants | 2660 participants |
| 1 | 17 | 17 | 34 | |
| 2 | 56 | 55 | 111 | |
| 3 | 26 | 27 | 53 | |
| unknown | 1 | 1 | 2 | |
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[1]
Measure Description: 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.
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HER2 status
[1] Measure Type: Number Unit of measure: Percent of participants |
Number Analyzed | 1328 participants | 1332 participants | 2660 participants |
| Negative | 87 | 87 | 174 | |
| Positive | 12 | 12 | 24 | |
| Unknown | 1 | 1 | 2 | |
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[1]
Measure Description: 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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Dr. Heidi Roschitzki-Voser, PhD Head Trial Activities / Deputy Director |
| Organization: | ETOP IBCSG Partners Foundation |
| Phone: | 41 31 511 94 00 |
| EMail: | Heidi.Roschitzki@etop.ibcsg.org |
Publications of Results:
Other Publications:
Francis P, Fleming G, Nasi ML, et al.: Tailored treatment investigations for premenopausal women with endocrine responsive (ER+ and/or PGR+) breast cancer: the SOFT, TEXT, and PERCHE trials. [Abstract] The Breast 12 (Suppl 1): A-P104, S44, 2003.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ETOP IBCSG Partners Foundation |
| ClinicalTrials.gov Identifier: | NCT00066703 |
| 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 ) |
| First Submitted: | August 6, 2003 |
| First Posted: | August 7, 2003 |
| Results First Submitted: | July 14, 2015 |
| Results First Posted: | April 5, 2016 |
| Last Update Posted: | January 2, 2024 |