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

NCT00309556 | Completed Phase 3

• 2 other identifiers: ABCSG-24Ro 09-1978
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 26

Brief Summary

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).

Conditions

Breast Cancer

Keywords

Epirubicin; Docetaxel; Capecitabine; Herceptin; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Rate of pathological complete remissions

  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).

  20 weeks

Secondary Outcomes (1)

• Rates of axillary lymph node involvement and breast-conserving procedures

  20 weeks

Study Arms (2)

A (experimental group)

ACTIVE COMPARATOR

Epirubicin/Docetaxel/Capecitabine-containing chemotherapy ± trastuzumab in HER-2 positive disease

Drug: Epirubicin; Drug: Docetaxel; Drug: Capecitabine; Drug: Trastuzumab

B (control group)

ACTIVE COMPARATOR

Epirubicin/Docetaxel-containing chemotherapy ± trastuzumab in HER-2 positive disease

Drug: Epirubicin; Drug: Docetaxel; Drug: Trastuzumab

Interventions

Epirubicin DRUG

6 cycles 75mg/m2 i.v. day 1 q3w

A (experimental group); B (control group)

Docetaxel DRUG

6 cycles 75mg/m2 i.v. day 1 q3w

Also known as: Taxotere

A (experimental group); B (control group)

Capecitabine DRUG

6 cycles 1000mg/m2 oral, day 1-14 q2d

Also known as: Xeloda

A (experimental group)

Trastuzumab DRUG

cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w)

Also known as: Herceptin

A (experimental group); B (control group)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• chest wall CT, abdomen CT, bilateral mammography: within 4 weeks before enrolment;
• laboratory requirements: within 2 weeks before enrolment
• hematology: neutrophils ≥ 4.0 x 109/l, platelets ≥ 150 x 109/l, haemoglobin ≥ 13 g/dl
• 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.
• renal function: creatinine ≤ 1 x ULN,
• 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

You may not qualify if:

• 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
• 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
• history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
• active uncontrolled infection
• 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

Sponsors & Collaborators

• Austrian Breast & Colorectal Cancer Study Group: lead
• Amgen: collaborator
• Ebewe Pharma GmbH: collaborator
• Hoffmann-La Roche: collaborator
• Sanofi: collaborator

Study Sites (26)

Hospital Guessing

Güssing, Burgenland, 7540, Austria

Location

Hospital Oberpullendorf

Oberpullendorf, Burgenland, 7350, Austria

Location

Hospital Oberwart

Oberwart, Burgenland, 7400, Austria

Location

State Hospital Klagenfurt

Klagenfurt, Carinthia, 9026, Austria

Location

Ordination Dr. Wette

Saint Veit A. D. Glan, Carinthia, 9300, Austria

Location

Hospital BHB St. Veit/Glan, Surgery

Saint Veit A. D. Glan, Carinthia, 9330, Austria

Location

State Hospital Villach

Villach, Carinthia, 9500, Austria

Location

State Hospital Wolfsberg

Wolfsberg, Carinthia, 9400, Austria

Location

Hospital Baden

Baden, Lower Austria, 2500, Austria

Location

Hospital Krems

Krems, Lower Austria, 3500, Austria

Location

Hospital of Wiener Neustadt

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Paracelsus Medical University Salzburg - Oncology

Salzburg, Salzburg, 5020, Austria

Location

Gynaegological Medical University Graz

Graz, Styria, 8036, Austria

Location

Medical University of Graz, Oncology

Graz, Styria, 8036, Austria

Location

State Hospital Leoben

Leoben, Styria, 8700, Austria

Location

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

District Hospital Kufstein

Kufstein, Tyrol, 6330, Austria

Location

State Hospital Kirchdorf

Kirchdorf, Upper Austria, 4560, Austria

Location

Hospital BHS Linz

Linz, Upper Austria, 4010, Austria

Location

General Hospital Linz

Linz, Upper Austria, 4020, Austria

Location

State Hospital Steyr

Steyr, Upper Austria, 4400, Austria

Location

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

Medical University Vienna, General Hospital

Vienna, Vienna, 1090, Austria

Location

State Hospital Vienna-Hietzing

Vienna, Vienna, 1130, Austria

Location

Hanusch Hospital

Vienna, Vienna, 1140, Austria

Location

State Hospital Feldkirch/Rankweil

Rankweil, Vorarlberg, 6807, Austria

Location

Related Publications (2)

• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

  PMID: 34037241 DERIVED

• Steger GG, Greil R, Lang A, Rudas M, Fitzal F, Mlineritsch B, Hartmann BL, Bartsch R, Melbinger E, Hubalek M, Stoeger H, Dubsky P, Ressler S, Petzer AL, Singer CF, Muss C, Jakesz R, Gampenrieder SP, Zielinski CC, Fesl C, Gnant M; Austrian Breast and Colorectal Study Group (ABCSG). Epirubicin and docetaxel with or without capecitabine as neoadjuvant treatment for early breast cancer: final results of a randomized phase III study (ABCSG-24). Ann Oncol. 2014 Feb;25(2):366-71. doi: 10.1093/annonc/mdt508. Epub 2013 Dec 16.

  PMID: 24347519 DERIVED

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Epirubicin; Docetaxel; Capecitabine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Guenther Steger, MD

  Austrian Breast & Colorectal Cancer Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 3, 2006
• Study Start: February 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2011
• Last Updated: December 30, 2011

Record last verified: 2011-12

Locations

AU (26)