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

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12607000023459
• Lead Sponsor: International Breast Cancer Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1994-11-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1200

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival[All patients will be assessed by clinicians for recurrence of disease every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life.]

Secondary Outcome Measures

Name	Time	Method
Overall survival[All patients will be assessed by clinicians for the secondary endpoints every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life. Treatment related side effects will also be assessed after every CMF (cyclophosphamide, methotrexate, 5-fluorouracil) administration.];Relapse site[All patients will be assessed by clinicians for the secondary endpoints every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life. Treatment related side effects will also be assessed after every CMF (cyclophosphamide, methotrexate, 5-fluorouracil) administration.];Side-effects[All patients will be assessed by clinicians for the secondary endpoints every third month during the first 2 years, every six months for years 3-5 and annually thereafter for life. Treatment related side effects will also be assessed after every CMF (cyclophosphamide, methotrexate, 5-fluorouracil) administration.]