None listed
Conditions
Brief summary
The use of tamoxifen has provided a reduction in deaths due to breast cancer in postmenopausal women with both node-positive and node-negative disease. However, the benefit of tamoxifen treatment may be confined to patients with oestrogen receptor positive disease and a standard adjuvant treatment for all postmenopausal patients with node-positive, oestrogen receptor negative disease has not yet been defined. Results from previous trials have indicated that the combination of CMF and tamoxifen (chemo-endocrine therapy) improved disease-free survival in all postmenopausal patients when compared with CMF or surgery alone. Patients with oestrogen receptor negative disease were found to benefit significantly from the combined treatments. Therefore, IBCSG VII will investigate the effectiveness of adding early combination chemotherapy and late additional chemotherapy to adjuvant tamoxifen compared to administering tamoxifen treatment alone in postmenopausal women.
Interventions
Arm B: Delayed CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at month 9, 12 and 15 + Tamoxifen (20mg orally daily for 5 years)
Arm C: Immediate CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at months 1,2,3 + Tamoxifen (20mg orally daily for 5 years)
Arm B: Delayed CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at month 9, 12 and 15 + Tamoxifen (20mg orally daily for 5 years) Arm C: Immediate CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at months 1,2,3 + Tamoxifen (20mg orally daily for 5 years) Arm D: Immediate CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at month 1,2,3 + delayed CMF (cyclophosphamide 100mg/m^2 orally days 1-14, methotrexate 40mg/m^2 iv days 1 and 8, fluorouracil 600mg/m^2 iv days 1 and 8; cycle duration = 28 days) - administered at month 9, 12 and 15 + Tamoxifen (20mg orally daily for 5 years)
Sponsors
International Breast Cancer Study Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) >52 years, with at least 1 year of amenorrhea OR b) <=52 years, with 3 years or more of amenorrhea OR c) >55 years, and who have had hysterectomy, without bilateral oopherectomy OR d) who have had Biochemical evidence of cessation of ovarian function (in questionable cases); All N+ patients with ER status determined for stratification; Tumour confined to breast with or without metastatic spread limited to ipsilateral axilla; Axillary nodes were not fixed and there was no arm oedema; WBC is >= 4,000/mm^3 and platelet count is >= 100,000/mm^3; Documented evidence of adequate renal ( creatinine < 120umol/L) and hepatic (bilirubin < 20umol/L, SGOT < 60 iu/L) function; Patients must give consent to be in study and be geographically accessible for follow-up; UICC performance status of 0 – 2; Either total mastectomy, quadrantectomy or lumpectomy with axillary clearance, performed no earlier than 6 weeks (addendum 2, previously 4 weeks) before randomization; A minimum of 8 lymph nodes has been histologically examined
Exclusion criteria
Malignant breast tumours other than carcinoma; Inflammatory carcinoma, with ulceration or infiltration of skin, or peau d'orange; T3b ot T4 breast carcinoma, or N2 or N3 nodal status; Bilateral malignancies, or mass in opposite breast; Less than total mastectomy procedures; Pregnant or lactating women; Previous or concomitant malignancy; Prior therapy for breast cancer; Clinically positive nodes in axilla opposite to affected breast; Other non-malignant systemic diseases preventing treatment options/follow-up; Psychiatric or addictive disorders preventing informed consent; Premenopausal patients with ER+ primary tumours; Bone scintigrams showing hot spots which cannot be confirmed as benign disease; N- patients (Addendum 1)
Outcome results
None listed