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| Sponsor: | Austrian Breast & Colorectal Cancer Study Group |
|---|---|
| Collaborators: |
Amgen GmbH Ebewe Pharma GmbH Hoffmann-La Roche Sanofi-Aventis |
| Information provided by (Responsible Party): | Austrian Breast & Colorectal Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT00309556 |
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 III |
| 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 |
| 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
|
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 |
Inclusion Criteria:
Results of the following assessments at the time of randomization must be available:
Exclusion Criteria:
Other serious illness or medical condition
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
Contacts and 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 | |
| Medical University of Graz, Oncology | |
| Graz, Styria, Austria, 8036 | |
| Gynaegological Medical University Graz | |
| 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 | |
| Hospital BHS Linz | |
| Linz, Upper Austria, Austria, 4010 | |
| General Hospital Linz | |
| Linz, Upper Austria, Austria, 4020 | |
| 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 | |
| Medical University Vienna, General Hospital | |
| Vienna, Austria, 1090 | |
| State Hospital Vienna-Hietzing | |
| Vienna, Austria, 1130 | |
| Hanusch Hospital | |
| Vienna, Austria, 1140 | |
| Study Chair: | Guenther Steger, MD | Austrian Breast & Colorectal Cancer Study Group |
More Information
| 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 |
|
Epirubicin Docetaxel Capecitabine Herceptin Breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Epirubicin Docetaxel Trastuzumab Capecitabine Fluorouracil |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |