None listed
Conditions
Interventions
Group 1 Type of group
Planned duration of chemotherapy: 2 months if an anthracycline is included (e.g., 4 cycles of EC or AC) or 4 months if no anthracycline is given (e.g., 6 cycles of CMF) is recommended. Unless medically contraindicated, an anthracycline-containing regimen using epirubicin should be given.
Exemestane 25 mg orally daily for until 5 years from date of randomization, unless relapse or intolerance should occur earlier. + Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless
Exemestane 25 mg orally daily for until 5 years from date of randomization, unless relapse or intolerance should occur earlier. + Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless relapse or intolerance should occur earlier. + Triptorelin (GnRH analogue) 3.75 mg by intramuscular injection every 28 days for 5 years from randomization, unless relapse or intolerance should occur earlier or surgical oophorectomy or ovarian irradiation is subsequently performed.
Sponsors
INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG,
Eligibility
Inclusion criteria
Inclusion criteria: • Histologically confirmed breast cancer confined to the breast and axillary nodes • 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: • 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 • Patients with microscopically positive axillary sentinel nodes allowed provided they were evaluated on a clinical trial evaluating microscopically positive lymph nodes • Total mastectomy with or without adjuvant radiotherapy • Inflammatory breast cancer • Supraclavicular node involvement • Enlarged internal mammary nodes (unless pathologically negative) • Histologically diagnosed synchronous bilateral invasive breast cancer within the past 2 months allowed if the bilateral disease meets all other eligibility criteria • Patient must be Premenopausal, Female • Fertile patients must use effective nonhormonal contraception
Exclusion criteria
Exclusion criteria: • No distant metastatic disease • No locally advanced, inoperable breast cancer, including any of the following characteristics: • No prior ipsilateral or contralateral invasive breast cancer • No prior deep venous thrombosis and/or embolism unless patient is medically suitable • No systemic cardiovascular disease that would preclude prolonged follow-up • No systemic pulmonary disease that would preclude prolonged follow-up • Not pregnant or nursing • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:NA Measure:Disease-free Survival Timepoints:For first time at a median follow up approximately 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:NA Measure:Overall Survival Timepoints:For first time at a median follow up approximately 5 years ; Outcome name:NA Measure:Systemic Disease-free Survivaln Timepoints:For first time at a median follow up approximately 5 years ; Outcome name:NA Measure:Sites of First Treatment Failure Timepoints:For first time at a median follow up approximately 5 years | — |
Countries
Hungaria, Italy, Switzerland
Outcome results
None listed