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Phase III Randomized Study of Triptorelin and Exemestane Versus Triptorelin and Tamoxifen in Premenopausal Women With Endocrine-Responsive Breast Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Related Publications Trial Contact Information Related Information Registry Information
Alternate Title
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Active
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Premenopausal
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NCI
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IBCSG-25-02 BIG-3-02, NABCI-IBCSG-25-02, EU-20347, IBCSG-25-02, NCT00066703, EUDRACT-2004-000168-28
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Special Category:
CTSU trial, NCI Web site featured trial Objectives - Compare the disease-free 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.
- Compare the sites of first treatment failure in patients treated with these regimens.
- Compare the incidence of second (non-breast) malignancies in patients treated with these regimens.
Entry Criteria Disease Characteristics:
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
Patient Characteristics:
Age Sex 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 Life expectancy Hematopoietic 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
Expected Enrollment 2639A total of 2,639 patients will be accrued for this study. Outcomes Primary Outcome(s)Disease-free survival
Secondary Outcome(s)Overall survival Systemic disease-free survival Quality of life Sites of first recurrence Late side effects of early menopause Causes of death without recurrence Incidence of second (nonbreast) malignancies
Outline This is a randomized, multicenter study. Patients are stratified according to participating center, concurrent adjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive triptorelin intramuscularly on day 1 every 28 days. Patients in the adjuvant chemotherapy stratum receive chemotherapy concurrently with triptorelin for at least 2 months (if anthracycline is included) or at least 4 months (if no anthracycline is included). Beginning after the completion of chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients receive oral tamoxifen daily.
- Arm II: Patients receive triptorelin as in arm I. Beginning after the completion of adjuvant chemotherapy or approximately 6-8 weeks after the initiation of triptorelin, patients also receive oral exemestane daily.
In both arms, treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Related PublicationsFrancis 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.
Trial Contact Information
Trial Lead Organizations International Breast Cancer Study Group | | | Olivia Pagani, MD, Protocol chair | | | |
Breast International Group | | | Olivia Pagani, MD, Protocol chair | | | | Trial Sites
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Australia |
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New South Wales |
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Campbelltown |
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| | | | Cancer Therapy Centre at Campbelltown Hospital |
| | Stephen Della-Fiorentina, MD | |
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Coffs Harbour |
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| | Coffs Harbour Health Campus |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Lismore |
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| | Lismore Base Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Liverpool |
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| | Cancer Therapy Centre at Liverpool Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Tamworth |
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| | Tamworth Base Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Taree |
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| | Manning Base Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Tweed Heads |
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| | Tweed Heads Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Waratah |
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| | Newcastle Mater Misericordiae Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Queensland |
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Brisbane |
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| | | Royal Brisbane and Women's Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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South Australia |
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Bedford Park |
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| | | Flinders Medical Centre |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Tasmania |
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Hobart |
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| | | Royal Hobart Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Launceston |
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| | Launceston General Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Victoria |
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Box Hill |
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| | | Box Hill Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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East Melbourne |
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| | Breast Unit Mercy Private |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
| | Peter MacCallum Cancer Centre |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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East Ringwood |
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| | Maroondah Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Fitzroy |
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| | St. Vincent's Hospital - Melbourne |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Heidelberg |
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| | Austin Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Melbourne |
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| | Alfred Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Western Australia |
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Perth |
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| | | Royal Perth Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Belgium |
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Brussels |
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| | | Institut Jules Bordet |
| | Contact Person | |
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Huy |
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| | Centre Hospitalier Hutois |
| | Joelle Collignon, MD | |
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Leuven |
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| | U.Z. Gasthuisberg |
| | Patrick Neven, MD, PhD | |
| Email:
patrick.neven@uz.kuleuven.ac.be |
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Liege |
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| | CHU Liege - Domaine Universitaire du Sart Tilman |
| | Guy Jerusalem, MD, PhD | |
| Email:
g.jerusalem@chu.ulg.ac.be |
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Verviers |
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| | Centre Hospitalier Peltzer-La Tourelle |
| | Jean Paul Salmon, MD | |
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Brazil |
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Rio Grande do Sul |
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Porto Alegre |
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| | | | Hospital de Clinicas de Porto Alegre |
| | Carlos Menke, MD, PhD | |
| Email:
menke@hcpa.ufrgs.br |
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Egypt |
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Cairo |
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| | | National Cancer Institute of Egypt |
| | Hussein Khaled, MD | |
| Email:
khaled@internetegypt.com |
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Mohandeseen |
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| | Cairo Oncology Center |
| | Contact Person | |
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Germany |
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Baden-Baden |
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| | | Brustzentrum Klinikum Mittelbaden |
| | GEAG Studiensekretariat | |
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Deggendorf |
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| | Klinikum Deggendorf |
| | GEAG Studiensekretariat | |
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Erlangen |
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| | Frauenklinik des Universitaetsklinikum Erlangen |
| | GEAG Studiensekretariat | |
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Frankfurt |
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| | Universitaetsfrauenklinik Frankfurt |
| | GEAG Studiensekretariat | |
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Goettingen |
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| | Universitaets-Frauenklinik Goettingen |
| | GEAG Studiensekretariat | |
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Karlsruhe |
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| | St. Vincentius - Kliniken |
| | GEAG Studiensekretariat | |
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Luebeck |
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| | Universitaetsklinikum Schleswig-Holstein - Campus Luebeck |
| | GEAG Studiensekretariat | |
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Mainz |
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| | Universitatsklinik Mainz |
| | GEAG Studiensekretariat | |
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Mannheim |
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| | Universitaetsfrauenklinik Mannheim |
| | GEAG Studiensekretariat | |
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Mutlangen |
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| | Klinikum Schwaebisch Gmuend Stauferklinik |
| | GEAG Studiensekretariat | |
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Nuremberg |
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| | Klinikum Nuernberg - Klinikum Nord |
| | GEAG Studiensekretariat | |
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Regensburg |
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| | Caritas - Krankenhaus Saint Josef |
| | B. Westhauser | |
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Rodewisch |
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| | Klinikum
Obergoeltzsch Rodewisch |
| | GEAG Studiensekretariat | |
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Rosenheim |
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| | Klinikum Rosenheim |
| | GEAG Studiensekretariat | |
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Tuttlingen |
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| | Klinikum Landkreis Tuttlingen |
| | GEAG Studiensekretariat | |
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Hungary |
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Budapest |
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| | | National Institute of Oncology |
| | Istvan Lang, MD, PhD, DSc | |
| Email:
lang@oncol.hu |
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India |
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Mumbai |
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| | | Tata Memorial Hospital |
| | Vani Parmar | |
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Italy |
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Aviano |
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| | | Centro di Riferimento Oncologico - Aviano |
| | Diana Crivellari, MD | |
| Email:
dcrivellari@oro.it |
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Bergamo |
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| | Ospedali Riuniti di Bergamo |
| | Carlo Tondini, MD | |
| Email:
carlo.tondoni@ospedaliriuniti.bergamo.it |
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Bolzano |
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| | Azienda Sanitaria di Bolzano |
| | Claudio Graiff, MD | |
| Email:
claudio.graiff@asbz.it |
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Brescia |
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| | Spedali Civili di Brescia |
| | Edda Simoncini, MD | |
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Carpi |
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| | Ospedale Civile Ramazzini |
| | Fabrizio Artioli, MD | |
| Email:
f.artioli@ausl.mo.it |
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Milan |
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| | European Institute of Oncology |
| | Aron Goldhirsch, MD | |
| Email:
aron.goldhirsch@ibcsg.org |
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Pavia |
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| | Fondazione Salvatore Maugeri |
| | Lorenzo Pavesi | |
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Prato |
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| | Misericordia e Dolce Hospital |
| | Angelo Di Leo, MD | |
| Email:
adileo@usl4.toscana.it |
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Rimini |
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| | Ospedale Civile Rimini |
| | Alberto Ravaioli, MD | |
| Email:
aravaiol@auslrn.net |
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Rozzano |
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| | Istituto Clinico Humanitas |
| | Armando Santoro, MD | |
| Email:
armando.santoro@humanitas.it |
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Udine |
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| | Policlinico Universitario Udine |
| | Fabio Puglisi | |
| Email:
fabio.puglisi@med.uniud.it |
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Varese |
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| | Ospedale di Circolo e Fondazione Macchi |
| | Graziella Pinotti | |
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New Zealand |
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Hamilton |
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| | | Waikato Hospital |
| | ANZ BCTG Operations Office - Department of Surgical Oncology | |
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Peru |
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Lima |
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| | | Instituto Nacional de Enfermedades Neoplasicas |
| | Henry Gomez Moreno | |
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Republic of South Africa |
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Johannesburg |
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| | | Sandton Oncology Centre |
| | Daniel Vorobiof, MD | |
| Email:
voro@global.co.za |
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Slovenia |
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Ljubljana |
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| | | Institute of Oncology - Ljubljana |
| | Bojana Pajk, MD | |
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Sweden |
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Gothenburg |
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| | | Sahlgrenska University Hospital |
| | Per Karlsson, MD | |
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Linkoping |
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| | University Hospital of Linkoping |
| | Barbro Linderholm | |
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Skovde |
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| | Skaraborgs Hospital |
| | Anders Nissborg, MD | |
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Switzerland |
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Basel |
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| | | Universitaetsspital-Basel |
| | Christoph Rochlitz, MD | |
| Email:
crochlitz@uhbs.ch |
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Bellinzona |
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| | Oncology Institute of Southern Switzerland |
| | Olivia Pagani, MD | |
| Email:
olivia.pagani@ibcsg.org |
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Bern |
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| | Inselspital Bern |
| | Stefan Aebi, MD | |
| Email:
stefan.aebi@insel.ch |
| | Oncocare Sonnenhof-Klinik Engeriedspital |
| | Katharina Buser, MD | |
| Email:
kbuser@sonnenhof.ch |
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Chur |
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| | Kantonsspital Graubuenden |
| | Roger von Moos, MD | |
| Email:
roger.vonmoos@ksgr.ch |
| | Onkologie-Praxis ZeTup Chur |
| | Hans-Joerg Senn, MD, PhD | |
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Lausanne |
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| | Centre Hospitalier Universitaire Vaudois |
| | Khalil Zaman | |
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Locarno |
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| | Ospedale "la Carita", Locarno |
| | Olivia Pagani, MD | |
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Lugano |
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| | Ospedale Civico |
| | Olivia Pagani, MD | |
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Mendrisio |
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| | Ospedale Beata Vergine |
| | Olivia Pagani, MD | |
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St. Gallen |
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| | Kantonsspital - St. Gallen |
| | Beat Thurlimann, MD | |
| Email:
beat.thuerlimann@kssg.ch |
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Thun |
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| | Regionalspital |
| | Jean Marc Luthi, MD | |
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Zurich |
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| | UniversitaetsSpital Zuerich |
| | Stephanie Von Orelli, MD | |
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United Kingdom |
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England |
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Cambridge |
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| | | | Addenbrooke's Hospital |
| | Clinical Trials and Statistics Unit - Institute of Cancer Research | |
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Peterborough |
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| | Peterborough Hospitals Trust |
| | Clinical Trials and Statistics Unit - Institute of Cancer Research | |
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South Shields |
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| | South Tyneside District Hospital |
| | Clinical Trials and Statistics Unit - Institute of Cancer Research | |
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Related Information Web site for additional information Featured trial article
Registry Information | | Official Title | | A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer | | Trial Start Date | | 2003-08-04 | | Trial Completion Date | | 2007-07-30 (estimated) | | Registered in ClinicalTrials.gov | | NCT00066703 | | Date Submitted to PDQ | | 2003-06-27 | | Information Last Verified | | 2008-09-09 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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