Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name TEXT

NCTNCT00066703 (opens ClinicalTrials.gov in a new tab)Other idIBCSG 25-02 / BIG 3-02Other idIBCSG 25-02Other idBIG 3-02Other idNABCI IBCSG 25-02

Overview

Status
Completed
Phase
Phase 3
Enrollment
2,672 participants (actual)
Sponsor
ETOP IBCSG Partners Foundation · Network
Design
Randomized · Open label (no masking)
Countries
17 countries

United States, Australia, Belgium, Brazil, Canada, Egypt, Germany, Hungary, India, Italy, New Zealand, Peru, Slovenia, South Africa, Sweden, Switzerland, United Kingdom

Start
3 Nov 2003
Primary completion
11 Mar 2011
Completion
23 Oct 2024
First posted
7 Aug 2003 (estimated)
Last update posted
6 Feb 2026
Conditions
Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052010201520202025
  1. Ph 3

    TEXT

    NCT00066703

    3 Nov 2003 to 23 Oct 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.

Interventions

  • exemestaneDrug
  • tamoxifenDrug
  • triptorelinDrug

Arms2

  • Active comparator

    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.

  • Experimental

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Disease-free Survival

    Time frame · 5-year estimate reported at a median follow-up of 72 months

    Registry description

    Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.

Secondary outcomes(3)
  1. Breast Cancer-free Interval

    Time frame · 5-year estimate reported at a median follow-up of 72 months

    Registry description

    Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.

  2. Distant Recurrence-free Interval

    Time frame · 5-year estimates reported at a median follow-up of 72 months

    Registry description

    Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up

  3. Overall Survival

    Time frame · 8-year estimates, reported at a median follow-up of 9 years

    Registry description

    Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 5-year estimate reported at a median follow-up of 72 months

Disease-free Survival

GroupValue (percentage of participants)
T+OFS87.3
E+OFS91.1
Secondary and other outcome results(3)
Secondary outcomeNumber· 5-year estimate reported at a median follow-up of 72 months

Breast Cancer-free Interval

GroupValue (percentage of participants)
T+OFS88.8
E+OFS92.8
Secondary outcomeNumber· 5-year estimates reported at a median follow-up of 72 months

Distant Recurrence-free Interval

GroupValue (percentage of participants)
T+OFS92.0
E+OFS93.8
Secondary outcomeNumber· 8-year estimates, reported at a median follow-up of 9 years

Overall Survival

GroupValue (percentage of participants)
T+OFS93.3
E+OFS93.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
T+OFSOvarian 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.–484 / 13211293 / 1321
E+OFSOvarian 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.–496 / 13171298 / 1317

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Randomized controlled trial · 2017

Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT.

Regan et al. 2017Annals of oncology : official journal of the European Society for Medical Oncologycited by 52

PMID 28911092PMC5834112DOI 10.1093/annonc/mdx285PUB-28911092

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2015

Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials.

Bernhard et al. 2015The Lancet. Oncologycited by 138

PMID 26092816PMC4562429DOI 10.1016/s1470-2045(15)00049-2PUB-26092816

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2014

Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.

Pagani et al. 2014The New England journal of medicinecited by 530

PMID 24881463PMC4175521DOI 10.1056/nejmoa1404037PUB-24881463

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultPagani O, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Goetz MP, Ciruelos EM, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer EP, Ruepp B, Loi S, Coates AS, Gelber RD, Goldhirsch A, Regan MM, Francis PA; SOFT and TEXT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. J Clin Oncol. 2023 Mar 1;41(7):1376-1382. doi: 10.1200/JCO.22.01064. Epub 2022 Dec 15. PMID 36521078
  • DerivedO'Regan RM, Ren Y, Zhang Y, Fleming GF, Francis PA, Pagani O, Walley BA, Kammler R, Dell'Orto P, Viale G, Loi S, Colleoni M, Treuner K, Regan MM. Identifying premenopausal patients with early-stage hormone receptor-positive breast cancer at minimal risk of distant recurrence by breast cancer index. Breast. 2026 Apr;86:104714. doi: 10.1016/j.breast.2026.104714. Epub 2026 Jan 29. PMID 41637791
  • DerivedRibi K, Cole BF, Fleming GF, Walley BA, Francis PA, Abdi E, Burstein HJ, Cheng KL, Chia SKL, Dakhil SR, Davidson NE, Della-Fiorentina SA, Frith AE, Levine E, Lupichuk S, Pritchard K, Salim M, Stearns V, Stewart J, Valero V, van der Westhuizen A, Pagani O, Loi S, Colleoni M, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J. Prognostic value of patient-reported depression in women with hormone-responsive early breast cancer in TEXT and SOFT. Cancer. 2025 Oct 1;131(19):e70094. doi: 10.1002/cncr.70094. PMID 40986647
  • DerivedPagani O, Francis PA, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Di Leo A, Coates AS, Goldhirsch A, Gelber RD, Regan MM; SOFT and TEXT Investigators and International Breast Cancer Study Group. Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT. J Clin Oncol. 2020 Apr 20;38(12):1293-1303. doi: 10.1200/JCO.18.01967. Epub 2019 Oct 16. PMID 31618131
  • DerivedFrancis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lang I, Gomez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE Jr, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):122-137. doi: 10.1056/NEJMoa1803164. Epub 2018 Jun 4. PMID 29863451
  • DerivedJohansson H, Gray KP, Pagani O, Regan MM, Viale G, Aristarco V, Macis D, Puccio A, Roux S, Maibach R, Colleoni M, Rabaglio M, Price KN, Coates AS, Gelber RD, Goldhirsch A, Kammler R, Bonanni B, Walley BA; the TEXT principal investigators. Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial. Breast Cancer Res. 2016 Nov 8;18(1):110. doi: 10.1186/s13058-016-0771-8. PMID 27825388
  • DerivedRegan MM, Francis PA, Pagani O, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Price KN, Coates AS, Goldhirsch A, Gelber RD. Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol. 2016 Jul 1;34(19):2221-31. doi: 10.1200/JCO.2015.64.3171. Epub 2016 Apr 4. PMID 27044936

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Completely resected disease * No clinically detectable residual loco-regional axillary disease * Prior surgery for primary breast cancer of 1 of the following types: * Total mastectomy with or without adjuvant radiotherapy * Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins negative\* for invasive disease and ductal carcinoma in situ) with planned radiotherapy NOTE: \*If all other margins are clear a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed * Tumor confined to the breast and axillary nodes * Tumor detected in internal mammary chain nodes by sentinel node procedure and is not enlarged is allowed * Axillary lymph node dissection or a negative axillary sentinel node biopsy required * Patients with negative or microscopically positive axillary sentinel nodes are eligible * Positive sentinel nodes must have either axillary dissection or radiation of axillary nodes * No distant metastases * No locally advanced inoperable breast cancer, including any of the following: * Inflammatory breast cancer * Supraclavicular node involvement * Enlarged internal mammary nodes (unless pathologically negative) * Bilateral synchronous invasive breast cancer allowed if disease meets all other eligibility criteria * No prior ipsilateral or contralateral invasive breast cancer * Hormone receptor status: * Estrogen and/or progesterone receptor positive * At least 10% of the tumor cells positive by immunohistochemistry * If \> 1 breast tumor, each tumor must be hormone receptor positive PATIENT CHARACTERISTICS: Age * Premenopausal Sex * Female Menopausal status * Premenopausal * Estradiol in the premenopausal range after prior surgery OR meets the following criteria: * Menstruating regularly for the past 6 months * Has not used any form of hormonal treatment (including hormonal contraception) within the past 6 months Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No systemic hepatic disease that would preclude prolonged follow-up Renal * No systemic renal disease that would preclude prolonged follow-up Cardiovascular * No systemic cardiovascular disease that would preclude prolonged follow-up * No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable Pulmonary * No systemic pulmonary disease that would preclude prolonged follow-up Other * Not pregnant or nursing * Fertile patients must use effective nonhormonal contraception * No history of noncompliance to medical regimens * No other nonmalignant systemic disease that would preclude prolonged follow-up * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following: * Stage I papillary thyroid cancer * Stage IA carcinoma of the cervix * Stage IA or B endometrioid endometrial cancer * Borderline or stage I ovarian cancer * No psychiatric, addictive, or other disorder that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Prior or concurrent neoadjuvant or adjuvant trastuzumab allowed Chemotherapy * No prior neoadjuvant or adjuvant chemotherapy Endocrine therapy * No prior tamoxifen, other selective estrogen-receptor modulators (SERMs) (e.g., raloxifene), or hormone replacement therapy for more than 1 year before breast cancer diagnosis * No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer * No concurrent oral or transdermal hormonal therapy * No other concurrent estrogen, progesterone, or androgens * No other concurrent aromatase inhibitors * No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections) Radiotherapy * See Disease Characteristics * No prior ovarian radiotherapy Surgery * See Disease Characteristics * No prior bilateral oophorectomy Other * No concurrent bisphosphonates, except in the following cases: * Bone density is at least 1.5 standard deviations below the young adult normal mean * Participation in a randomized clinical study testing bisphosphonates in the adjuvant breast cancer setting * No other concurrent investigational agents

PepBank is a research reference. Talk to a doctor before you use any peptide.