Study Summary
This trial is testing whether suppressing ovarian function and combining it with either tamoxifen or exemestane is more effective than tamoxifen alone in treating premenopausal women with hormone-responsive breast cancer.
Eligible Conditions
- Estrogen Receptor Positive Breast Cancer
- Breast Cancer
- Stage IIB Breast Cancer
- Stage IIIA Breast Cancer
- Stage IB Breast Cancer
- Stage IIA Breast Cancer
- Progesterone Receptor Positive Tumor
- Stage IA Breast Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 8-year estimates, reported at a median follow-up of 8 years
Month 67
Breast Cancer-free Interval
Disease-free Survival
Distant Recurrence-free Interval
Year 8
Overall Survival
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
3 Treatment Groups
Tamoxifen
1 of 3
T+OFS
1 of 3
E+OFS
1 of 3
Active Control
Experimental Treatment
3066 Total Participants · 3 Treatment Groups
Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 3
T+OFSExperimental Group · 6 Interventions: Laboratory Biomarker Analysis, Oophorectomy, Quality-of-Life Assessment, Radiation Therapy, Tamoxifen, Triptorelin · Intervention Types: Other, Procedure, Other, Radiation, Drug, Drug
E+OFSExperimental Group · 6 Interventions: Exemestane, Laboratory Biomarker Analysis, Oophorectomy, Quality-of-Life Assessment, Radiation Therapy, Triptorelin · Intervention Types: Drug, Other, Procedure, Other, Radiation, Drug
TamoxifenActiveComparator Group · 3 Interventions: Laboratory Biomarker Analysis, Quality-of-Life Assessment, Tamoxifen · Intervention Types: Other, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exemestane
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Tamoxifen
FDA approved
Tryptophan
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8-year estimates, reported at a median follow-up of 8 years
Who is running the clinical trial?
International Breast Cancer Study GroupLead Sponsor
28 Previous Clinical Trials
22,052 Total Patients Enrolled
ETOP IBCSG Partners FoundationLead Sponsor
60 Previous Clinical Trials
54,594 Total Patients Enrolled
NSABP Foundation IncNETWORK
86 Previous Clinical Trials
133,936 Total Patients Enrolled
Breast International GroupOTHER
33 Previous Clinical Trials
51,880 Total Patients Enrolled
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
114,922 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,125,789 Total Patients Enrolled
NCIC Clinical Trials GroupNETWORK
189 Previous Clinical Trials
141,775 Total Patients Enrolled
Southwest Oncology GroupNETWORK
386 Previous Clinical Trials
258,587 Total Patients Enrolled
North Central Cancer Treatment GroupNETWORK
48 Previous Clinical Trials
78,066 Total Patients Enrolled
Gini FlemingPrincipal InvestigatorETOP IBCSG Partners Foundation
3 Previous Clinical Trials
164 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:For the centers in the International Breast Cancer Study Groups (IBCSG), the patients must have completed the baseline Quality of Life (QL) Forms prior to the randomization; the only exceptions are the cognitive or physical impairment that interferes with the QL assessment or the inability to read any of the languages available on the IBCSG QL forms
Patients who receive prior adjuvant and/or neoadjuvant chemotherapy should be randomized around 8 months after their final dose of chemotherapy
, for the adjuvant treatment of patients with early stage HER2-positive breast cancer
Patients must have hormone receptor positive tumors; if there is more than one breast tumor, each tumor must be hormone receptor positive; the tumors must be determined using immunohistochemistry; estrogen receptor (ER) and/or progesterone receptor (PgR) must be greater than or equal to 10% of the tumor cells positive by immunohistochemical evaluation; biochemical determination alone is not acceptable.
Either an axillary lymph node dissection or a negative axillary sentinel node biopsy is required
This text is explaining that in order to quality control measures for a protocol, resected breast cancer pathology material should be available for submission for central review.
Patients who did not receive chemotherapy should be randomized within 12 weeks after definitive surgery; such patients should have estradiol (E2) in the premenopausal range following surgery; the only patients who do not require testing of estradiol (E2) to confirm premenopausal status are those who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception.
If a woman has temporary chemotherapy-induced amenorrhea and regains premenopausal status within eight months of the final dose of chemotherapy, she is eligible to participate in the study
References
- Regan, M.M., B.A. Walley, P.A. Francis, G.F. Fleming, I. Láng, H.L. Gómez, M. Colleoni, et al.. 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”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdx285.
- Ribi, Karin, Weixiu Luo, Jürg Bernhard, Prudence A. Francis, Harold J. Burstein, Eva Ciruelos, Meritxell Bellet, et al.. 2016. “Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women with Early Breast Cancer: Patient-reported Outcomes in the Suppression of Ovarian Function Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2015.64.8675.
- Pagani, Olivia, Meredith M. Regan, Barbara A. Walley, Gini F. Fleming, Marco Colleoni, István Láng, Henry L. Gomez, et al.. 2014. “Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1404037.
- Francis, Prudence A., Olivia Pagani, Gini F. Fleming, Barbara A. Walley, Marco Colleoni, István Láng, Henry L. Gómez, et al.. 2018. “Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1803164.
- Pagani, Olivia, Prudence A. Francis, Gini F. Fleming, Barbara A. Walley, Giuseppe Viale, Marco Colleoni, István Láng, et al.. 2020. “Absolute Improvements in Freedom from Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results from TEXT and SOFT”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.18.01967.
- Francis, Prudence A., Meredith M. Regan, Gini F. Fleming, István Láng, Eva Ciruelos, Meritxell Bellet, Hervé R. Bonnefoi, et al.. 2015. “Adjuvant Ovarian Suppression in Premenopausal Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1412379.
- Bernhard, Jürg, Weixiu Luo, Karin Ribi, Marco Colleoni, Harold J Burstein, Carlo Tondini, Graziella Pinotti, et al.. 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”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00049-2.
- Regan, Meredith M., Prudence A. Francis, Olivia Pagani, Gini F. Fleming, Barbara A. Walley, Giuseppe Viale, Marco Colleoni, et al.. 2016. “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”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2015.64.3171.
- Regan, Meredith M., Olivia Pagani, Gini F. Fleming, Barbara A. Walley, Karen N. Price, Manuela Rabaglio, Rudolf Maibach, et al.. 2013. “Adjuvant Treatment of Premenopausal Women with Endocrine-responsive Early Breast Cancer: Design of the TEXT and SOFT Trials”. The Breast. Elsevier BV. doi:10.1016/j.breast.2013.08.009.
- Ribi K, Luo W, Bernhard J, Francis PA, Burstein HJ, Ciruelos E, Bellet M, Pavesi L, Lluch A, Visini M, Parmar V, Tondini C, Kerbrat P, Perello A, Neven P, Torres R, Lombardi D, Puglisi F, Karlsson P, Ruhstaller T, Colleoni M, Coates AS, Goldhirsch A, Price KN, Gelber RD, Regan MM, Fleming GF. Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial. J Clin Oncol. 2016 May 10;34(14):1601-10. doi: 10.1200/JCO.2015.64.8675. Epub 2016 Mar 28.
- Regan MM, Walley BA, Francis PA, Fleming GF, Lang I, Gomez HL, Colleoni M, Tondini C, Pinotti G, Salim M, Spazzapan S, Parmar V, Ruhstaller T, Abdi EA, Gelber RD, Coates AS, Goldhirsch A, Pagani O. 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. Ann Oncol. 2017 Sep 1;28(9):2225-2232. doi: 10.1093/annonc/mdx285.
- Regan 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.
- Francis PA, Regan MM, Fleming GF, Lang I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer CE Jr, Walley BA, Coleman R, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD; SOFT Investigators; International Breast Cancer Study Group. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 Jan 29;372(5):436-46. doi: 10.1056/NEJMoa1412379. Epub 2014 Dec 11.
- Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1.
- Francis 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.
- Pagani 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.
- 2003. "Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00066690.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments