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Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer

Information source: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Epirubicin (Drug); Docetaxel (Drug); Capecitabine (Drug); Trastuzumab (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Austrian Breast & Colorectal Cancer Study Group

Official(s) and/or principal investigator(s):
Guenther Steger, MD, Study Chair, Affiliation: Austrian Breast & Colorectal Cancer Study Group


Primarily, this clinical investigation compares the rates (percentages) of pathological complete remissions attained at the time of final surgery following 6 cycles each of epirubicin + docetaxel + capecitabine-containing chemotherapy ± trastuzumab (in HER-2 positive disease) vs. epirubicin + docetaxel-containing chemotherapy ± trastuzumab (in HER-2 negative disease).

Clinical Details

Official title: A Randomized Phase III Study Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF to Epirubicin and Docetaxel + G-CSF as Neoadjuvant Treatment for Early HER-2 Negative Breast Cancer and Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF Trastuzumab to Epirubicin and Docetaxel + G-CSF Trastuzumab as Neoadjuvant Treatment for Early HER-2 Positive Breast Cancer

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rate of pathological complete remissions

Secondary outcome: Rates of axillary lymph node involvement and breast-conserving procedures

Detailed description: This study is a prospective, randomized, multicentre, phase III trial in the neoadjuvant treatment of patients with primary breast cancer and no distant metastases. Patients will be stratified at inclusion according to the centre, to the clinical tumour stage (T1, T2, T3, T4a-c), the axillary lymph node status (positive, negative), the menopausal status (pre-menopausal, post-menopausal), histology (invasive ductal, invasive lobular, mixed), the hormone-receptor status (positive [ER+/PR+, ER+/PR-, ER-/PR+], negative [ER-/PR-], not determinable]), the HER-2 status (positive, negative, not determinable), the grading (G1/G2, G3, not determinable) and will be randomly assigned to receive either 6 cycles of neoadjuvant epirubicin, docetaxel and capecitabine ± trastuzumab in HER-2 positive disease or 6 cycles of neoadjuvant epirubicin and docetaxel ± trastuzumab in HER-2 positive disease.


Minimum age: 19 Years. Maximum age: 80 Years. Gender(s): Female.


Inclusion Criteria:

- Female patients with histologically proven, core-biopsied, invasive breast cancer of

any clinical and/or radiological T-stage (except for T4d)

- Age 18-70 years

- WHO performance status ≤ 2

- No prior or current neoplasm except for curatively treated non-melanoma skin cancer,

in situ carcinoma of the cervix

- No distant disease / secondary carcinoma judged clinically and at least by chest

X-ray, liver sonography, and bone scan upon randomization

- No medical and/or cardiologic contraindication to receive an anthracycline- and

taxane-containing chemotherapy regimen. Normal cardiac function must be confirmed by LVEF (echocardiography or Muga scan). The result must be above 50% or above the institution's ULN

- Results of the following assessments at the time of randomization must be available:

1. chest wall CT, abdomen CT, bilateral mammography: within 4 weeks before enrolment; 2. laboratory requirements: within 2 weeks before enrolment 3. hematology: neutrophils ≥ 4. 0 x 109/l, platelets ≥ 150 x 109/l, haemoglobin ≥ 13 g/dl 4. hepatic function: total bilirubin < 1 x ULN, ASAT (SGOT) and ALAT (SGPT) < 1x ULN, alkaline phosphatase < 1 x ULN. In case of abnormal values, liver function tests have to be repeated within 3 days before study treatment. 5. renal function: creatinine ≤ 1 x ULN, 6. histology, grading, hormone receptor status, HER-2/neu status

- Signed and dated informed consent before the start of specific protocol procedures

- Negative pregnancy test in the presence of childbearing potential

Exclusion Criteria:

- Stage T4d / inflammatory breast cancer

- Pregnant or lactating patients; patients of childbearing potential must implement

adequate contraceptive measures during study participation

- Pre-existing motor or sensory neurotoxicity of a severity ≥ WHO grade 2

- Preoperative local treatment for breast cancer (i. e. incomplete surgery,


- Prior or concomitant systemic antitumor therapy

- Other serious illness or medical condition

1. congestive heart failure or unstable angina pectoris, even if medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrythmias 2. history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent 3. active uncontrolled infection 4. unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids

- Concurrent treatment with corticosteroids except as use for the prophylactic regimen,

inhalational use, treatment of acute hypersensitivity reactions, treatment of nausea/vomiting or chronic treatment (initiated > 6 months prior to study entry) at low dose (≤ 20 mg methylprednisolone or equivalent)

- Known hypersensitivity against taxanes and/or epirubicin and/or


- Known dihydropyrimidine-dehydrogenase (DPD) deficit

- Treatment with an investigational drug within 30 days prior to study entry

- Legally incapacitated and/or other circumstances which make it unfeasible for the

subject to understand the nature, meaning and consequences of the clinical study

- Concurrent psychiatric illness according to ICD (alcohol addiction) at the time of

study entry

Locations and Contacts

Paracelsus Medical University Salzburg - Oncology, Salzburg 5020, Austria

Hanusch Hospital, Vienna 1140, Austria

Medical University Vienna, General Hospital, Vienna 1090, Austria

State Hospital Vienna-Hietzing, Vienna 1130, Austria

Hospital Guessing, Guessing, Burgenland 7540, Austria

Hospital Oberpullendorf, Oberpullendorf, Burgenland 7350, Austria

Hospital Oberwart, Oberwart, Burgenland 7400, Austria

State Hospital Klagenfurt, Klagenfurt, Carinthia 9026, Austria

Hospital BHB St. Veit/Glan, Surgery, St. Veit a. d. Glan, Carinthia 9330, Austria

Ordination Dr. Wette, St. Veit a. d. Glan, Carinthia 9300, Austria

State Hospital Villach, Villach, Carinthia 9500, Austria

State Hospital Wolfsberg, Wolfsberg, Carinthia 9400, Austria

Hospital Baden, Baden bei Wien, Lower Austria 2500, Austria

Hospital Krems, Krems, Lower Austria 3500, Austria

Hospital of Wiener Neustadt, Wiener Neustadt, Lower Austria 2700, Austria

Gynaegological Medical University Graz, Graz, Styria 8036, Austria

Medical University of Graz, Oncology, Graz, Styria 8036, Austria

State Hospital Leoben, Leoben, Styria 8700, Austria

Medical University of Innsbruck, Innsbruck, Tyrol 6020, Austria

District Hospital Kufstein, Kufstein, Tyrol 6330, Austria

State Hospital Kirchdorf, Kirchdorf, Upper Austria 4560, Austria

General Hospital Linz, Linz, Upper Austria 4020, Austria

Hospital BHS Linz, Linz, Upper Austria 4010, Austria

State Hospital Steyr, Steyr, Upper Austria 4400, Austria

Klinikum Wels-Grieskirchen, Wels, Upper Austria 4600, Austria

State Hospital Feldkirch/Rankweil, Rankweil, Vorarlberg 6807, Austria

Additional Information

Click here for more information about this study: ABCSG-Studien closed

Starting date: February 2005
Last updated: December 29, 2011

Page last updated: August 23, 2015

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