Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (TEXT)
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| ClinicalTrials.gov Identifier: NCT00066703 |
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Recruitment Status :
Active, not recruiting
First Posted : August 7, 2003
Results First Posted : April 5, 2016
Last Update Posted : November 17, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: exemestane Drug: tamoxifen Drug: triptorelin | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2672 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | November 3, 2003 |
| Actual Primary Completion Date : | March 11, 2011 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: tamoxifen
Other Name: Nolvadex Drug: triptorelin Other Names:
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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.
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Drug: exemestane
Other Name: Aromasin Drug: triptorelin Other Names:
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- Disease-free Survival [ Time Frame: 5-year estimate reported at a median follow-up of 72 months ]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.
- Breast Cancer-free Interval [ Time Frame: 5-year estimate reported at a median follow-up of 72 months ]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.
- Distant Recurrence-free Interval [ Time Frame: 5-year estimates reported at a median follow-up of 72 months ]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
- Overall Survival [ Time Frame: 8-year estimates, reported at a median follow-up of 9 years ]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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
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Completely resected disease
- No clinically detectable residual loco-regional axillary disease
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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
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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
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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
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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
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Hormone receptor status:
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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
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PATIENT CHARACTERISTICS:
Age
- Premenopausal
Sex
- Female
Menopausal status
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Premenopausal
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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
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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
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066703
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| Study Chair: | Olivia Pagani, MD | Oncology Institute of Southern Switzerland | |
| Study Chair: | Barbara Walley, MD, FRCPC | Tom Baker Cancer Centre |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ETOP IBCSG Partners Foundation |
| ClinicalTrials.gov Identifier: | NCT00066703 |
| Other Study ID Numbers: |
IBCSG 25-02 / BIG 3-02 IBCSG 25-02 BIG 3-02 ( Other Identifier: Breast International Group ) NABCI IBCSG 25-02 EU-20347 2004-000168-28 ( EudraCT Number ) CDR0000316458 ( Registry Identifier: CT.gov ) |
| First Posted: | August 7, 2003 Key Record Dates |
| Results First Posted: | April 5, 2016 |
| Last Update Posted: | November 17, 2022 |
| Last Verified: | November 2022 |
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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 |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Triptorelin Pamoate Exemestane Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |
Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Hormonal |