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Phase III Randomized Study of Ovarian-Function Suppression and Tamoxifen or Exemestane With Versus Without Adjuvant Chemotherapy in Premenopausal Women With Endocrine-Responsive Resected 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
Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected 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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Completed
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Premenopausal
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NCI
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IBCSG-26-02 BIG-4-02, NABCI-IBCSG-26-02, EU-20401, IBCSG-26-02, NCT00066807, EUDRACT-2005-002626-59
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Special Category:
CTSU trial Objectives - Compare ovarian function suppression and tamoxifen or exemestane with vs without adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast cancer.
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare sites of first treatment failure in patients treated with these regimens.
- Compare the incidence of second nonbreast malignancies in patients treated with these regimens.
- Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically confirmed breast cancer confined to the breast and axillary nodes
- No distant metastatic disease
- Tumor detected in the internal mammary chain by sentinel node procedure allowed
- Must have undergone 1 of the following procedures for primary breast cancer within the past 12 weeks and have no known clinical residual locoregional disease:
- Total mastectomy with or without adjuvant radiotherapy
- Breast-conserving surgery (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins clear* of invasive cancer and ductal carcinoma in situ) followed by 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]
- Prior axillary lymph node dissection or negative axillary sentinel node biopsy required
- Patients with microscopically positive axillary sentinel nodes allowed provided they were evaluated on a clinical trial evaluating microscopically positive lymph nodes
- No locally advanced, inoperable breast cancer, including any of the following characteristics:
- Inflammatory breast cancer
- Supraclavicular node involvement
- Enlarged internal mammary nodes (unless pathologically negative)
- No prior ipsilateral or contralateral invasive breast cancer
- Histologically diagnosed synchronous bilateral invasive breast cancer within the past 2 months allowed if the bilateral disease meets all other eligibility criteria
- Hormone receptor status:
- Estrogen receptor and/or progesterone receptor positive in each tumor
- At least 10% of tumor cells positive by immunohistochemistry
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - No prior neoadjuvant or adjuvant chemotherapy
- Neoadjuvant or
adjuvant trastuzumab (Herceptin®) allowed
Endocrine therapy - No prior neoadjuvant or adjuvant endocrine therapy after breast cancer diagnosis
- No prior tamoxifen or other selective estrogen-receptor modulator (e.g., raloxifene) within 1 year before the breast cancer diagnosis
- No other concurrent oral or transdermal hormonal therapy, including any of the following:
- Estrogen
- Progesterone
- Androgens
- Aromatase inhibitors
- Hormone replacement therapy
- Oral or other hormonal contraceptives, including implant and depot injections
- Raloxifene or other selective estrogen-receptor modulators
Radiotherapy - See Disease Characteristics
- No prior ovarian irradiation
Surgery - See Disease Characteristics
- No prior bilateral oophorectomy
Other - No other prior neoadjuvant therapy
- No other concurrent investigational agents
- No concurrent bisphosphonates unless bone density has been documented at least 1.5 standard deviations below the young adult normal mean or the patient is participating in a randomized clinical trial setting testing bisphosphonates in the adjuvant breast cancer setting
Patient Characteristics:
Age Sex Menopausal status - Premenopausal
- Estradiol in the premenopausal range after surgery
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 prior deep venous thrombosis and/or embolism unless patient is medically suitable
- No systemic cardiovascular disease that would preclude prolonged follow-up
Pulmonary - No systemic pulmonary disease that would preclude prolonged follow-up
Other - Not pregnant or nursing
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Fertile patients must use effective nonhormonal contraception
- No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ without invasion, contralateral or ipsilateral carcinoma in situ of the breast
- No prior or concurrent nonbreast invasive malignancy within the past 5 years that is nonrecurrent 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 other nonmalignant systemic disease that would preclude prolonged follow-up
- No history of noncompliance with medical regimens
- No psychiatric, addictive, or other disorder that would preclude study compliance or giving informed consent
Expected Enrollment 1750A total of 1,750 patients will be accrued for this study within 7 years. Outcomes Primary Outcome(s)Relapse (i.e., local, regional, or distant) Contralateral breast cancer Second (nonbreast) primary tumor Death
Secondary Outcome(s)Overall survival
Outline This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more), method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation), chemotherapy if randomized to arm II (not containing vs containing an anthracycline or taxane), and endocrine agent (tamoxifen vs exemestane vs selected by subsequent randomization in the TEXT trial). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive ovarian function suppression comprising triptorelin intramuscularly on day 1 every 28 days for 5 years, oophorectomy, or ovarian irradiation. Beginning when ovarian function has been suppressed, patients also receive oral tamoxifen or exemestane once daily for 5 years in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive ovarian function suppression as in arm I and concurrent chemotherapy for at least 2 months (if an anthracycline is included) or at least 4 months (if no anthracycline is included). Beginning after the completion of chemotherapy or when ovarian function has been suppressed, patients also receive oral tamoxifen or exemestane as in arm I.
Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 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 | | | Rosalba Torrisi, MD, Protocol chair | | | |
Breast International Group | | | Rosalba Torrisi, MD, Protocol chair | | | |
Related Information Web site for additional information
Registry Information | | Official Title | | A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy | | Trial Start Date | | 2003-08-04 | | Registered in ClinicalTrials.gov | | NCT00066807 | | Date Submitted to PDQ | | 2003-07-02 | | Information Last Verified | | 2007-04-05 |
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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