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

This study has been completed.
Sponsor:
Collaborators:
Amgen
Ebewe Pharma GmbH
Hoffmann-La Roche
Sanofi
Information provided by (Responsible Party):
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00309556
First received: March 31, 2006
Last updated: December 29, 2011
Last verified: December 2011
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Drug: Epirubicin
Drug: Docetaxel
Drug: Capecitabine
Drug: Trastuzumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • Rate of pathological complete remissions [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    at the time of final surgery after 6 cycles of Arm A (Epirubicin/ Docetaxel/ Capecitabine-containing chemotherapy ± Trastuzumab in HER-2 positive disease) vs. Arm B (Epirubicin/Docetaxel-containing chemotherapy ± Trastuzumab in HER-2 positive disease).


Secondary Outcome Measures:
  • Rates of axillary lymph node involvement and breast-conserving procedures [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    at the time of final surgery in Arm A (± trastuzumab in HER-2 positive disease) vs. Arm B (± trastuzumab in HER-2 positive disease).


Enrollment: 536
Study Start Date: February 2005
Study Completion Date: November 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A (experimental group)
Epirubicin/Docetaxel/Capecitabine-containing chemotherapy ± trastuzumab in HER-2 positive disease
Drug: Epirubicin
6 cycles 75mg/m2 i.v. day 1 q3w
Drug: Docetaxel
6 cycles 75mg/m2 i.v. day 1 q3w
Other Name: Taxotere
Drug: Capecitabine
6 cycles 1000mg/m2 oral, day 1-14 q2d
Other Name: Xeloda
Drug: Trastuzumab
cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w)
Other Name: Herceptin
Active Comparator: B (control group)
Epirubicin/Docetaxel-containing chemotherapy ± trastuzumab in HER-2 positive disease
Drug: Epirubicin
6 cycles 75mg/m2 i.v. day 1 q3w
Drug: Docetaxel
6 cycles 75mg/m2 i.v. day 1 q3w
Other Name: Taxotere
Drug: Trastuzumab
cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w)
Other Name: Herceptin

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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, radiotherapy)
  • 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 fluorouracil/capecitabine
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309556

Locations
Austria
Hospital Guessing
Guessing, Burgenland, Austria, 7540
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
Hospital Oberwart
Oberwart, Burgenland, Austria, 7400
State Hospital Klagenfurt
Klagenfurt, Carinthia, Austria, 9026
Ordination Dr. Wette
St. Veit a. d. Glan, Carinthia, Austria, 9300
Hospital BHB St. Veit/Glan, Surgery
St. Veit a. d. Glan, Carinthia, Austria, 9330
State Hospital Villach
Villach, Carinthia, Austria, 9500
State Hospital Wolfsberg
Wolfsberg, Carinthia, Austria, 9400
Hospital Baden
Baden bei Wien, Lower Austria, Austria, 2500
Hospital Krems
Krems, Lower Austria, Austria, 3500
Hospital of Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, 2700
Gynaegological Medical University Graz
Graz, Styria, Austria, 8036
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben
Leoben, Styria, Austria, 8700
Medical University of Innsbruck
Innsbruck, Tyrol, Austria, 6020
District Hospital Kufstein
Kufstein, Tyrol, Austria, 6330
State Hospital Kirchdorf
Kirchdorf, Upper Austria, Austria, 4560
General Hospital Linz
Linz, Upper Austria, Austria, 4020
Hospital BHS Linz
Linz, Upper Austria, Austria, 4010
State Hospital Steyr
Steyr, Upper Austria, Austria, 4400
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria, 4600
State Hospital Feldkirch/Rankweil
Rankweil, Vorarlberg, Austria, 6807
Paracelsus Medical University Salzburg - Oncology
Salzburg, Austria, 5020
Hanusch Hospital
Vienna, Austria, 1140
Medical University Vienna, General Hospital
Vienna, Austria, 1090
State Hospital Vienna-Hietzing
Vienna, Austria, 1130
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Amgen
Ebewe Pharma GmbH
Hoffmann-La Roche
Sanofi
Investigators
Study Chair: Guenther Steger, MD Austrian Breast & Colorectal Cancer Study Group
  More Information

Additional Information:
No publications provided by Austrian Breast & Colorectal Cancer Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00309556     History of Changes
Other Study ID Numbers: ABCSG-24, Ro 09-1978
Study First Received: March 31, 2006
Last Updated: December 29, 2011
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
Epirubicin
Docetaxel
Capecitabine
Herceptin
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Docetaxel
Epirubicin
Fluorouracil
Trastuzumab
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014