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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00066703




Registration number
NCT00066703
Ethics application status
Date submitted
6/08/2003
Date registered
7/08/2003
Date last updated
2/01/2024

Titles & IDs
Public title
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Scientific title
A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Secondary ID [1] 0 0
IBCSG 25-02
Secondary ID [2] 0 0
IBCSG 25-02 / BIG 3-02
Universal Trial Number (UTN)
Trial acronym
TEXT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - exemestane
Treatment: Drugs - tamoxifen
Treatment: Drugs - triptorelin

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.


Treatment: Drugs: exemestane


Treatment: Drugs: tamoxifen


Treatment: Drugs: triptorelin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival
Timepoint [1] 0 0
5-year estimate reported at a median follow-up of 72 months
Secondary outcome [1] 0 0
Breast Cancer-free Interval
Timepoint [1] 0 0
5-year estimate reported at a median follow-up of 72 months
Secondary outcome [2] 0 0
Distant Recurrence-free Interval
Timepoint [2] 0 0
5-year estimates reported at a median follow-up of 72 months
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
8-year estimates, reported at a median follow-up of 9 years

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
2672
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Cancer Therapy Centre at Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [3] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [4] 0 0
Cancer Therapy Centre at Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Tamworth Base Hospital - Tamworth
Recruitment hospital [6] 0 0
Manning Base Hospital - Taree
Recruitment hospital [7] 0 0
Tweed Heads Hospital - Tweed Heads
Recruitment hospital [8] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [9] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [10] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [11] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [12] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [13] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [14] 0 0
Breast Unit Mercy Private - East Melbourne
Recruitment hospital [15] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [16] 0 0
St. Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [17] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [18] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [19] 0 0
Maroondah Hospital - Ringwood East
Recruitment hospital [20] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
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2450 - Coffs Harbour
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2480 - Lismore
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2170 - Liverpool
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2340 - Tamworth
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2430 - Taree
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2485 - Tweed Heads
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2298 - Waratah
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4029 - Brisbane
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5042 - Bedford Park
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment postcode(s) [12] 0 0
7250 - Launceston
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3002 - East Melbourne
Recruitment postcode(s) [15] 0 0
3065 - Fitzroy
Recruitment postcode(s) [16] 0 0
3084 - Heidelberg
Recruitment postcode(s) [17] 0 0
3004 - Melbourne
Recruitment postcode(s) [18] 0 0
3135 - Ringwood East
Recruitment postcode(s) [19] 0 0
6000 - Perth
Recruitment outside Australia
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California
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Colorado
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Connecticut
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District of Columbia
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Indiana
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Kansas
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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Prato
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Rozzano
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Udine
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New Zealand
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Hamilton
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Peru
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Lima
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Slovenia
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Ljubljana
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South Africa
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Johannesburg
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Sweden
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Gothenburg
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Sweden
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Linkoping
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Sweden
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Skovde
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Switzerland
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Basel
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Bellinzona
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Chur
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Lausanne
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Locarno
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Thun
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Zurich
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United Kingdom
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England

Funding & Sponsors
Primary sponsor type
Other
Name
ETOP IBCSG Partners Foundation
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Breast International Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00066703
Trial related presentations / 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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Olivia Pagani, MD
Address 0 0
Oncology Institute of Southern Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00066703