None listed
Conditions
Brief summary
The HE10/08 trial was a large observational single-arm adjuvant study, with prospective collection of biological material. It was specifically designed to be used as a validation study to our previously conducted randomized trial (ACTRN12610000151033), in our continuous quest for pivotal molecular predictors of outcome or treatment effect in patients with operable breast cancer. Patients received dose-dense Epirubicin/Paclitaxel/Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF). Granulocyte colony-stimulating factor was given prophylactically. Ondansetron + Dexamethazone was recommended as antiemetic treatment in all patients. All patients entered the study who were eligible to receive trastuzumab (HER-2 overexpression or HER-2 gene amplification), received the drug every 3 weeks for 1 year after the completion of chemotherapy. In these patients hormonal treatment with tamoxifen or anastrazole started concurrently with initiation of treatment with trastuzumab. All premenopausal patients with receptor positive status were to receive tamoxifen p.o. daily for 5 years and goserelin (zoladex) p.o. every 3 months for 2 years. All postmenopausal patients with receptor positive status were to be treated with anastrazole for 5 years. RT was required for all patients (pre- or post -menopausal), providing that they had either a partial mastectomy or tumor size > 5cm and /or more than 4 positive lymph nodes, irrespectively the type of surgery (conservative or radical).
Interventions
Patients were treated with epirubicin [110 mg/m2 intravenous infusion (IV)] every 2 weeks for 3 cycles followed by 3 cycles of paclitaxel (200mg/m2 IV) every 2 weeks and 3 cycles of CMF (cyclophosphamide; 600 mg/m2 IV , methotrexate; 45 mg/m2 IV and fluorouracil; 600 mg/m2 IV) every 2 weeks.
Filgrastim was recommended in each cycle. Ondansetron + Dexamethazone was recommended as antiemetic treatment in all patients. All patients entered the study who were eligible to receive trastuzumab, receiv
Patients were treated with epirubicin [110 mg/m2 intravenous infusion (IV)] every 2 weeks for 3 cycles followed by 3 cycles of paclitaxel (200mg/m2 IV) every 2 weeks and 3 cycles of CMF (cyclophosphamide; 600 mg/m2 IV , methotrexate; 45 mg/m2 IV and fluorouracil; 600 mg/m2 IV) every 2 weeks. Filgrastim was recommended in each cycle. Ondansetron + Dexamethazone was recommended as antiemetic treatment in all patients. All patients entered the study who were eligible to receive trastuzumab, received it for 1 year after the completion of chemotherapy. In these patients hormonal treatment with tamoxifen or anastrazole (orally) was started concurrently with initiation of treatment with trastuzumab. All premenopausal patients with receptor positive status received tamoxifen daily for 5 years and goserelin (zoladex) every 3 months for 2 years. All postmenopausal patients with receptor positive status will be treated with anastrazole daily for 5 years. Radiotherapy (RT) was required for all patients (pre- or post -menopausal), providing that they had either a partial mastectomy or tumor size > 5cm and /or more than 4 positive lymph nodes, irrespectively the type of surgery (conservative or radical). The study was used as a validation study. The aim was to observe the prognostic role of selected biomarkers on disease-free survival (DFS) and overall survival (OS) as well as the acute and long-term toxicity. Time of observation: 10 years
Sponsors
Hellenic Cooperative Oncology Group
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histology-confirmed epithelial cancer of the mammary gland. -Pre and post menopausal patients with operable breast cancer and involved axillary lymph nodes (T 1-3 N1-2 Mo) or patients without involved axillary nodes (T1-3 N0 Mo) (i.e. those with >= 2cm or T>1cm with at least one of the following: grade 3, age < 34 years, negative hormonal status, infiltration of blood vessels or lymphatic vessels or nerves, HER-2 (receptor tyrosine kinase) overexpression, high S fraction). WBC > 4 x 109 / l, platelets > 100 x 109 / l. Serum creatinine, SGOT, SGPT, gamma-GT, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital.Performance status (WHO) 0 or 1.Age > 18 years.Previous surgical treatment: Either radical surgery or, for a partial mastectomy, a histologically confirmed safe margin and the results of the axillary node dissection available.No evidence of significant cardiac disease. No previous antitumor chemotherapy or radiation.Time from surgery 2 to 8 weeks.Informed consent of the patient according to the dispositions of the Helsinki convention and its Tokyo and Venice amendments and to individual institutional policy.
Exclusion criteria
-History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (BP> 200/110 mm Hg). A normal baseline LVEF should be demonstrated by MUGA scan or ECHO. -Documented residual or metastatic disease. -Prior chemotherapy, hormonal or radiation treatment -Pregnant or in puerperium period women, or patients unwilling to follow adequate contraceptive methods during treatment period. -History of prior cancer except for curatively treated basal-cell carcinoma of the skin or in situ carcinoma of the cervix uteri. -Patients who can not fully understand and complete the inform consent form, or patients who can not follow treatment or follow up schedule.
Outcome results
None listed