None listed
Conditions
Brief summary
The optimal duration of adjuvant chemotherapy in premenopausal patients with operable early stage breast cancer is currently unknown and it is thought that relapse of disease following adjuvant therapy may be due to the presence of cells which are non-responsive to first cycles of treatment. Therefore, IBCSG VI will investigate whether 3 cycles of initial adjuvant chemotherapy are as effective as 6 cycles and whether the addition of 3 cycles of chemotherapy after a treatment-free interval is as effective as administering an initial course of chemotherapy alone in premenopausal patients.
Interventions
Arm A: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8)x 6 monthly cycles (duration of each cycle = 28 days)
Arm B: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) x 6 monthly cycles (duration of cycle = 28 days) + 3 single reinduction cycles (duration of cycle = 28 days) of CMF (cyclophosphamide 100mg/
Arm A: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8)x 6 monthly cycles (duration of each cycle = 28 days) Arm B: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) x 6 monthly cycles (duration of cycle = 28 days) + 3 single reinduction cycles (duration of cycle = 28 days) of CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) at 9, 12 and 15 months Arm C: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) x 3 monthly cycles (duration of cycle = 28 days) Arm D: Adjuvant CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) x 3 monthly cycles (duration of cycle = 28 days) + 3 single reinduction cycles (duration of cycle = 28 days) of CMF (cyclophosphamide 100mg/m^2 orally daily days 1-14; methotrexate 40mg/m^2 iv days 1 and 8; 5-fluorouracil 600mg/m^2 iv days 1 and 8) at 6, 9 and 12 months
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, and LNMP (last normal menstrual period) within 1 year OR b) <=52 years, and LNMP within 3 years, or currently menstruating OR c) <=55 years, and hysterectomy without bilateral oophorectomy OR d) Biochemical confirmation of continuing 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