Adjuvant chemotherapy in node positive postmenopausal breast cancer patients: endocrine vs. chemo-endocrine vs. chemo-endocrine with delayed chemotherapy.

International Breast Cancer Study Group0 sites1,200 target enrollmentNovember 3, 1994

Overview

No summary available.

Registry

who.int

Start Date

November 3, 1994

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

International Breast Cancer Study Group

•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

•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\)