Adjuvant Treatment for patients with node-positive Breast Cancer Docetaxel sequentially or in combination with Doxorubicin, followed by CMF (cyclophosphamide, methotrexate, fluorouracil) vs. Doxorubicin alone or in combination with Cyclophosphamide, followed by CMF (cyclophosphamide, methotrexate, fluorouracil).

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12606000529549
• Lead Sponsor: sanofi-aventisTalavera Corporate CentreBuilding D12-24 Talavera RoadMacquarie Park, NSW 2113

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-05-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2730

Inclusion Criteria

Written or witnessed informed consent. Histologically proven breast cancer. Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection. Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin. Histologic examination of the tumor: invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of eight resected lymph nodes. The determination of ER (estrogen receptor) and PgR (progesterone receptor) is mandatory. Karnofsky Performance status index > or equal to 70 %. Normal cardiac function must be confirmed by assessment of LVEF (MUGA scan or echocardiography). Laboratory requirements: (within 14 days prior to registration) a) Hematology: i) Neutrophils > or equal to 2.0 x 109/Lii) Platelets > or equal to 100 x 109/Liii) Hemoglobin > or equal to 10 g/dLb) Hepatic functioni) Total bilirubin < or equal to 1 x Upper Normal Limitii) ASAT (SGOT) and ALAT (SGPT) < or equal to 1.5 x Upper Normal Limitiii) Alkaline phosphatase < or equal to 2.5 x Upper Normal Limitc) Renal function:i) Creatinine < or equal to 150 µmol/L (1.5 mg/dL); Complete staging work-up within 3 months prior to registration, including bilateral mammography, chest Xray (PA and lateral) and/or CT-scan, abdominal ultrasound and/or CT scan, bone scan. Patients must be accessible for treatment and follow-up. Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.

Exclusion Criteria

Prior systemic anticancer therapy for breast cancer (chemo-hormono-immuno-therapy). Prior radiation therapy for breast cancer. Pregnant, or lactating patients. Any locally advanced (clinical or pathological T4 and/or N2-known N3) or metastatic (M1) breast carcinoma. Patients with inoperable residual axillary nodal disease or with supraclavicular nodes.Pre-existing motor or sensory neurotoxicity of a severity > or equal to grade 2 by NCI criteria. Other serious illness or medical condition:o Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias.o History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.o Active uncontrolled infection.o Active peptic ulcer, unstable diabetes mellitus. Past or current history of other neoplasm except for:o Curatively treated basal cell skin cancer.o Adequately treated in situ carcinoma of the cervix. In regard to past or current history of other breast carcinoma, criteria of exclusion are:o Past history of ipsilateral or past/current history of contralateral invasive breast carcinoma.o Past or current history of contralateral ductal in situ breast carcinoma. A past or current history of ipsilateral ductal in situ or lobular in situ (ipsilateral or contralateral) breast carcinoma is not a criteria of exclusion. Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< or equal to 20 mg methylprednisolone or equivalent). Concurrent treatment with hormonal replacement therapy: this treatment should be stopped before study entry. Definite contraindications for the use of corticosteroids. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry. Concurrent treatment with any other anti-cancer therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified