Abstract

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by International Breast Cancer Study Group (IBCSG). Clinical trials include: CMF with or without prednisone for pre/perimenopausal patients with breast cancer and 1–3 positive nodes. Ludwig/IBCSG Trial ICMF + prednisone combined with or without oophorectomy for pre/perimenopausal patients with breast cancer and 4 or more positive nodes. Ludwig/IBCSG Trial IIAdjuvant therapy for postmenopausal elderly patients (older than 65): observation versus prednisone tamoxifen. Ludwig/IBCSG Trial IIIAdjuvant therapy for postmenopausal, 65 years or younger, node-positive breast cancer patients: observation versus prednisone + tamoxifen versus CMF + prednisone + tamoxifen. Ludwig/IBCSG Trial IVAdjuvant perioperative chemotherapy. Ludwig/IBCSG Trial VAdjuvant therapy in node-positive pre/perimenopausal breast cancer patients: CMF 3 versus 6 with or without reintroduction of chemotherapy. IBCSG Trial VIAdjuvant chemotherapy in node-positive postmenopausal breast cancer patients: endocrine versus chemo-endocrine versus chemo-endocrine with delayed chemotherapy. IBCSG Trial VIIAdjuvant therapy in pre- and perimenopausal patients with node-negative breast cancer. Observation versus LH-RH analogue versus CMF versus CMF + LN-RH analogue. IBCSG Trial VIIIAdjuvant therapy in postmenopausal patients with node-negative breast cancer. Tamoxifen versus CMF followed by tamoxifen. IBCSG Trial IXSurgical therapy with or without axillary node clearance for breast cancer in elderly patients who receive adjuvant therapy with tamoxifen. IBCSG Trial 10–93Adjuvant therapy for premenopausal patients with node-positive breast cancer who are suitable for endocrine therapy alone. IBCSG Trial 11–93Adjuvant therapy for post/perimenopausal patients with node-positive breast cancer who have estrogen-receptor-positive tumors. IBCSG Trial 12–93Adjuvant therapy for premenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone. IBCSG Trial 13–93Adjuvant therapy for post perimenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone. IBCSG Trial 14–93High dose EC × 3 supported by PBSC versus EC/AC × 4 followed by CMF as adjuvant treatment for high-risk operable Stage II and Stage III breast cancer in premenopausal and young postmenopausal (<65 years) patients. IBCSG Trial 15–95Adjuvant therapy for postmenopausal patients with operable breast cancer who have estrogen-receptor or progesterone-receptor-positive tumors. Tamoxifen versus letrozole versus tamoxifen followed by letrozole versus letrozole followed by tamoxifen. BIG 1–98 / IBCSG Trial 18–98Maintenance chemotherapy in hormone non-responsive breast cancer: low-dose cytotoxics as “anti-angiogenesis treatment” following adjuvant induction chemotherapy for patients with ER-negative and PgR-negative breast cancer. IBCSG Trial 22–00A randomized trial of axillary dissection versus no axillary dissection for patients with clinically node-negative breast cancer and micrometastases in the sentinel node. IBCSG Trial 23–01Suppression of Ovarian Function Trial (SOFT). A Phase III trial evaluating the role of ovarian function suppression (OFS) and the role of exemestane as adjuvant therapies for premenopausal women with endocrine-responsive breast cancer. Tamoxifen versus OFS + tamoxifen versus OFS + exemestane. BIG 2–02/IBCSG Trial 24–02Tamoxifen and Exemestane Trial (TEXT). A Phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer. Ovarian function suppression + tamoxifen versus ovarian function suppression + exemestane. BIG 3–02/IBCSG Trial 25–02Premenopausal Endocrine Responsive Chemotherapy Trial (PERCHE) A Phase III trial evaluating the role of chemotherapy as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer who receive endocrine therapy.Chemotherapy + OFS + tamoxifen/exemestane versus OFS + tamoxifen/ exemestane. BIG 4–02/IBCSG Trial 26–02Chemotherapy for radically resected loco-regional relapse. BIG 1-02/IBCSG Trial 27–02/NSABP Protocol B-37Chemotherapy adjuvant study for women at advanced Age (CASA) Phase III trial evaluating the role of adjuvant pegylated liposomal doxorubicin (PLD) for women (age 66 years or older) with endocrine non-responsive breast cancer who are not suitable for being offered a “standard chemotherapy regimen”. BIG 1–05/IBCSG Trial 32–05

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