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CompletedNCT00066703TEXTUpdated Feb 6, 2026Results posted

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

A Phase 3 interventional study of exemestane and tamoxifen in Breast Cancer, sponsored by ETOP IBCSG Partners Foundation. Completed at 228 sites in 17 countries. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by ETOP IBCSG Partners Foundation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,672
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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.

Read the detailed description

OBJECTIVES:

  • Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen.
  • Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.

OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.

02

Conditions studied

  • Breast Cancer

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Keywords

  • stage II breast cancer
  • stage IIIA breast cancer
  • estrogen receptor-positive breast cancer
  • progesterone receptor-positive breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 2,672 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

ETOP IBCSG Partners Foundation is the lead sponsor of 50 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,672 participants (actual)

Study arms

  • 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.

    Drug: tamoxifen · Drug: 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.

    Drug: exemestane · Drug: triptorelin

Interventions

  • Drugexemestane

    Also known as: Aromasin

  • Drugtamoxifen

    Also known as: Nolvadex

  • Drugtriptorelin

    Also known as: GnRH analogue, Trelstar Depot, Decapeptyl Depot

06

What researchers measure

Primary outcomes

  1. Disease-free Survival

    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.

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

Secondary outcomes

  1. Breast Cancer-free Interval

    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.

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

  2. Distant Recurrence-free Interval

    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

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

  3. Overall Survival

    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.

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

07

Results

Posted Apr 5, 2016

Participant flow

2672 patients were randomized between 7Nov03 and 7Apr11 at 182 centers in 15 countries.

Participant flow — Overall Study
MilestoneT+OFSE+OFS
Started13341338
Completed10341026
Not completed300312
Withdrew: Adverse event83116
Withdrew: Death30
Withdrew: Lack of efficacy12678
Withdrew: Lost to follow-up4543
Withdrew: Withdrawal by subject4375

Outcome measures

PrimaryDisease-free Survival

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.

Time frame:
5-year estimate reported at a median follow-up of 72 months
Reported as:
Number · percentage of participants
Disease-free Survival
percentage of participantsT+OFSE+OFS
Disease-free Survival87.3 (85.7 to 88.7)91.1 (89.7 to 92.3)
Statistical analysis
  • T+OFS vs E+OFS · Log Rank · p = .0002 · Hazard ratio (hr): 0.717 · 95% CI 0.602 to 0.855T+OFS is the reference group in the estimation of the hazard ratio.
SecondaryBreast Cancer-free Interval

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.

Time frame:
5-year estimate reported at a median follow-up of 72 months
Reported as:
Number · percentage of participants
Breast Cancer-free Interval
percentage of participantsT+OFSE+OFS
Breast Cancer-free Interval88.8 (87.3 to 90.1)92.8 (91.6 to 93.9)
Statistical analysis
  • T+OFS vs E+OFS · Log Rank · p = <.0001 · Hazard ratio (hr): 0.664 · 95% CI .548 to .804T+OFS is the reference group for the estimation of the hazard ratio.
SecondaryDistant Recurrence-free Interval

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

Time frame:
5-year estimates reported at a median follow-up of 72 months
Reported as:
Number · percentage of participants
Distant Recurrence-free Interval
percentage of participantsT+OFSE+OFS
Distant Recurrence-free Interval92.0 (90.7 to 93.1)93.8 (92.7 to 94.8)
Statistical analysis
  • T+OFS vs E+OFS · Log Rank · p = 0.02 · Hazard ratio (hr): 0.777 · 95% CI 0.624 to 0.967T+OFS was the reference group in the estimation of the hazard ratio
SecondaryOverall Survival

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.

Time frame:
8-year estimates, reported at a median follow-up of 9 years
Reported as:
Number · percentage of participants
Overall Survival
percentage of participantsT+OFSE+OFS
Overall Survival93.3 (92.1 to 94.3)93.4 (92.2 to 94.4)
Statistical analysis
  • T+OFS vs E+OFS · Log Rank · p = 0.84 · Hazard ratio (hr): 0.98 · 95% CI 0.79 to 1.22T+OFS was the reference group in the estimation of the hazard ratio

Adverse events

Collected over Assessed every 3 months for the first year, then every 6 months until year 6. Reported at a median follow-up of 72 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
T+OFS—484/1,321 (36.6%)1,293/1,321 (97.9%)
E+OFS—496/1,317 (37.7%)1,298/1,317 (98.6%)
Most frequent serious events
Showing 10 of 163
Most frequent serious events
EventT+OFSE+OFS
Hot flashes/flushesVascular disorders149/1321127/1317
Pain - JointMusculoskeletal and connective tissue disorders69/1321139/1317
HypertensionVascular disorders100/132190/1317
Mood alteration - depressionPsychiatric disorders59/132151/1317
InsomniaPsychiatric disorders54/132144/1317
Fatigue (asthenia, lethargy, malaise)General disorders32/132141/1317
Pain - VaginaReproductive system and breast disorders11/132133/1317
Thrombosis/embolism (vascular access-related)Injury, poisoning and procedural complications29/132113/1317
Renal/Genitourinary-Other (Specify)Renal and urinary disorders24/13217/1317
FractureInjury, poisoning and procedural complications11/132118/1317
Most frequent other events
Showing 10 of 22
Most frequent other events
EventT+OFSE+OFS
Hot flashes/flushesVascular disorders1081/13211076/1317
Pain - JointMusculoskeletal and connective tissue disorders953/13211030/1317
Fatigue (asthenia, lethargy, malaise)General disorders807/1321760/1317
Sweating (diaphoresis)Skin and subcutaneous tissue disorders752/1321705/1317
InsomniaPsychiatric disorders738/1321714/1317
Vaginal drynessReproductive system and breast disorders611/1321683/1317
Mood alteration - depressionPsychiatric disorders592/1321610/1317
OsteoporosisMusculoskeletal and connective tissue disorders388/1321588/1317
LibidoPsychiatric disorders486/1321555/1317
NauseaGastrointestinal disorders446/1321478/1317

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)T+OFSE+OFSTotal
Age44 (40 to 46)43 (39 to 46)43 (40 to 46)
Sex: Female, Male
Sex: Female, Male(Participants)T+OFSE+OFSTotal
Female132813322660
Male000
Lymph-node status
Lymph-node status(percent of participants)T+OFSE+OFSTotal
Negative5252104
Positive484896
Tumor size
Tumor size(percent of participants)T+OFSE+OFSTotal
<=2 cm6059119
>=2 cm394079
unknown112
Tumor grade
Tumor grade(percent of participants)T+OFSE+OFSTotal
1171734
25655111
3262753
unknown112
HER2 status
HER2 status(percent of participants)T+OFSE+OFSTotal
Negative8787174
Positive121224
Unknown112
08

Study locations

228 sites
  • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
    Burbank, California 91505, United States
  • Rebecca and John Moores UCSD Cancer Center
    La Jolla, California 92093-0658, United States
  • Providence Holy Cross Cancer Center
    Mission Hills, California 91346-9600, United States
  • Desert Regional Medical Center Comprehensive Cancer Center
    Palm Springs, California 92262, United States
  • Sutter Cancer Center at Roseville Medical Center
    Roseville, California 95661, United States
  • Sutter Cancer Center
    Sacramento, California 95816, United States
  • Mercy General Hospital
    Sacramento, California 95819, United States
  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California 94115, United States
  • Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
    Whittier, California 90602, United States
  • University of Colorado Cancer Center at UC Health Sciences Center
    Aurora, Colorado 80045, United States
  • Shaw Regional Cancer Center
    Edwards, Colorado 81632, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • Front Range Cancer Specialists
    Fort Collins, Colorado 80528, United States
  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    Farmington, Connecticut 06360-2875, United States
  • Sibley Memorial Hospital
    Washington D.C., District of Columbia 20016, United States
  • Walter Reed Army Medical Center
    Washington D.C., District of Columbia 20307-5001, United States
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224, United States
  • Northeast Georgia Medical Center
    Gainesville, Georgia 30501, United States
  • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    Boise, Idaho 83712, United States
  • Kootenai Cancer Center - Coeur d'Alene
    Coeur d'Alene, Idaho 83814, United States
  • Resurrection Medical Center
    Chicago, Illinois 60631, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637-1470, United States
  • Decatur Memorial Hospital Cancer Care Institute
    Decatur, Illinois 62526, United States
  • Evanston Hospital
    Evanston, Illinois 60201-1781, United States
  • CCOP - Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Elkhart Clinic, LLC
    Elkhart, Indiana 46514-2098, United States
  • Elkhart General Hospital
    Elkhart, Indiana 46515, United States
  • Fort Wayne Medical Oncology and Hematology
    Fort Wayne, Indiana 46845, United States
  • Howard Community Hospital
    Kokomo, Indiana 46904, United States
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
    La Porte, Indiana 46350, United States
  • Saint Joseph Regional Medical Center
    Mishawaka, Indiana 46545-1470, United States
  • CCOP - Northern Indiana CR Consortium
    South Bend, Indiana 46601, United States
  • Memorial Hospital of South Bend
    South Bend, Indiana 46601, United States
  • Michiana Hematology-Oncology, PC - South Bend
    South Bend, Indiana 46601, United States
  • South Bend Clinic
    South Bend, Indiana 46617, United States
  • Siouxland Hematology-Oncology Associates, LLP
    Sioux City, Iowa 51101, United States
  • Cancer Center of Kansas, PA - Chanute
    Chanute, Kansas 66720, United States
  • Cancer Center of Kansas, PA - Dodge City
    Dodge City, Kansas 67801, United States
  • Cancer Center of Kansas, PA - El Dorado
    El Dorado, Kansas 67042, United States
  • Cancer Center of Kansas-Independence
    Independence, Kansas 67301, United States
  • Cancer Center of Kansas, PA - Kingman
    Kingman, Kansas 67068, United States
  • Lawrence Memorial Hospital
    Lawrence, Kansas 66044, United States
  • Cancer Center of Kansas, PA - Newton
    Newton, Kansas 67114, United States
  • Menorah Medical Center
    Overland Park, Kansas 66209, United States
  • Cancer Center of Kansas, PA - Parsons
    Parsons, Kansas 67357, United States
  • Cancer Center of Kansas, PA - Pratt
    Pratt, Kansas 67124, United States
  • Cancer Center of Kansas, PA - Salina
    Salina, Kansas 67401, United States
  • Shawnee Mission Medical Center
    Shawnee Mission, Kansas 66204, United States
  • Cotton-O'Neil Cancer Center
    Topeka, Kansas 66606, United States
  • Cancer Center of Kansas, PA - Wellington
    Wellington, Kansas 67152, United States
  • Associates in Womens Health, PA - North Review
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, PA - Medical Arts Tower
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, PA - Wichita
    Wichita, Kansas 67214, United States
  • CCOP - Wichita
    Wichita, Kansas 67214, United States
  • Via Christi Cancer Center at Via Christi Regional Medical Center
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas, PA - Winfield
    Winfield, Kansas 67156, United States
  • Greenebaum Cancer Center at University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Mercy Medical Center
    Baltimore, Maryland 21202, United States
  • Suburban Hospital
    Bethesda, Maryland 20814, United States
  • Frederick Memorial Hospital Regional Cancer Therapy Center
    Frederick, Maryland 21701, United States
  • Tufts Medical Center Cancer Center
    Boston, Massachusetts 02111, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Bethke Cancer Center at Emerson Hospital
    Concord, Massachusetts 01742, United States
  • Addison Gilbert Hospital
    Gloucester, Massachusetts 01930, United States
  • Lowell General Hospital
    Lowell, Massachusetts 01854, United States
  • NSMC Cancer Center - Peabody
    Peabody, Massachusetts 01960, United States
  • MidMichigan Medical Center - Midland
    Midland, Michigan 48670, United States
  • William Beaumont Hospital - Royal Oak Campus
    Royal Oak, Michigan 48073, United States
  • Lakeland Regional Cancer Care Center - St. Joseph
    Saint Joseph, Michigan 49085, United States
  • Lakeside Cancer Specialists, PLLC
    Saint Joseph, Michigan 49085, United States
  • Fairview Ridges Hospital
    Burnsville, Minnesota 55337, United States
  • Mercy and Unity Cancer Center at Mercy Hospital
    Coon Rapids, Minnesota 55433, United States
  • Fairview Southdale Hospital
    Edina, Minnesota 55435, United States
  • Mercy and Unity Cancer Center at Unity Hospital
    Fridley, Minnesota 55432, United States
  • HealthEast Cancer Care at St. John's Hospital
    Maplewood, Minnesota 55109, United States
  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
  • Hennepin County Medical Center - Minneapolis
    Minneapolis, Minnesota 55415, United States
  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
    Robbinsdale, Minnesota 55422-2900, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • CCOP - Metro-Minnesota
    Saint Louis Park, Minnesota 55416, United States
  • Park Nicollet Cancer Center
    Saint Louis Park, Minnesota 55416, United States
  • Regions Hospital Cancer Care Center
    Saint Paul, Minnesota 55101, United States
  • United Hospital
    Saint Paul, Minnesota 55102, United States
  • Ridgeview Medical Center
    Waconia, Minnesota 55387, United States
  • Truman Medical Center - Hospital Hill
    Kansas City, Missouri 64108, United States
  • Saint Luke's Cancer Institute at Saint Luke's Hospital
    Kansas City, Missouri 64111, United States
  • St. Joseph Medical Center
    Kansas City, Missouri 64114, United States
  • North Kansas City Hospital
    Kansas City, Missouri 64116, United States
  • CCOP - Kansas City
    Kansas City, Missouri 64131, United States
  • Research Medical Center
    Kansas City, Missouri 64132, United States
  • Heartland Regional Medical Center
    Saint Joseph, Missouri 64506, United States
  • Saint Louis University Cancer Center
    St Louis, Missouri 63110, United States
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    St Louis, Missouri 63110, United States
  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
    Grand Island, Nebraska 68803, United States
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    Omaha, Nebraska 68198-6805, United States
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
    Marlton, New Jersey 08053, United States
  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
    Vineland, New Jersey 08360, United States
  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    Voorhees Township, New Jersey 08043, United States

Showing the first 100 of 228 sites across 17 countries.

09

References and documents

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.
  • Regan MM, Pagani O, Walley B, Torrisi R, Perez EA, Francis P, Fleming GF, Price KN, Thurlimann B, Maibach R, Castiglione-Gertsch M, Coates AS, Goldhirsch A, Gelber RD; SOFT/TEXT/PERCHE Steering Committee and the International Breast Cancer Study Group. Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy? Ann Oncol. 2008 Jul;19(7):1231-1241. doi: 10.1093/annonc/mdn037. Epub 2008 Mar 5. PubMed 18325918 ↗
  • Rabaglio M, Ruepp B; Soft/Text/Perche Steering Committee. Death due to liver failure during endocrine therapy for premenopausal breast cancer. Acta Oncol. 2010 Aug;49(6):874-6. doi: 10.3109/0284186X.2010.484813. No abstract available. PubMed 20482225 ↗
  • Regan MM, Pagani O, Fleming GF, Walley BA, Price KN, Rabaglio M, Maibach R, Ruepp B, Coates AS, Goldhirsch A, Colleoni M, Gelber RD, Francis PA; International Breast Cancer Study; GroupSOFT and TEXT Investigators. Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials. Breast. 2013 Dec;22(6):1094-100. doi: 10.1016/j.breast.2013.08.009. Epub 2013 Oct 2. PubMed 24095609 ↗
  • 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. PubMed 24881463 ↗
  • Pagani 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. PubMed 36521078 ↗
  • O'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. PubMed 41637791 ↗
  • Ribi 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. PubMed 40986647 ↗
  • 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. PubMed 31618131 ↗
  • 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. PubMed 29863451 ↗
  • 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. PubMed 28911092 ↗
  • Johansson 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. PubMed 27825388 ↗
  • 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. PubMed 27044936 ↗
  • Bernhard J, Luo W, Ribi K, Colleoni M, Burstein HJ, Tondini C, Pinotti G, Spazzapan S, Ruhstaller T, Puglisi F, Pavesi L, Parmar V, Regan MM, Pagani O, Fleming GF, Francis PA, Price KN, Coates AS, Gelber RD, Goldhirsch A, Walley BA. 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. Lancet Oncol. 2015 Jul;16(7):848-58. doi: 10.1016/S1470-2045(15)00049-2. Epub 2015 Jun 16. PubMed 26092816 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00066703
Lead sponsor
ETOP IBCSG Partners Foundation
Collaborators
National Cancer Institute (NCI), Breast International Group
Responsible party
Sponsor
First posted
Aug 7, 2003
Start date
Nov 3, 2003
Primary completion
Mar 11, 2011
Completion
Oct 23, 2024
Results posted
Apr 5, 2016
Last update
Feb 6, 2026

Study contacts

Olivia Pagani, MD
study chair · Oncology Institute of Southern Switzerland
Barbara Walley, MD, FRCPC
study chair · Tom Baker Cancer Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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