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Breast CancerPhase 3NCT00309556

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

A Phase 3 study testing Epirubicin, Docetaxel and Capecitabine in people with Breast Cancer, run by Austrian Breast & Colorectal Cancer Study Group at 26 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 80 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Epirubicin, Docetaxel and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
536 participants
Where
26 sitesAustria
Study dates
Feb 2005to Nov 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Austria26 sites

  • Hospital Baden

    Baden, Lower Austria, 2500

  • Gynaegological Medical University Graz

    Graz, Styria, 8036

  • Medical University of Graz, Oncology

    Graz, Styria, 8036

  • Hospital Guessing

    Guessing, Burgenland, 7540

  • Medical University of Innsbruck

    Innsbruck, Tyrol, 6020

  • State Hospital Kirchdorf

    Kirchdorf, Upper Austria, 4560

  • State Hospital Klagenfurt

    Klagenfurt, Carinthia, 9026

  • Hospital Krems

    Krems, Lower Austria, 3500

  • District Hospital Kufstein

    Kufstein, Tyrol, 6330

  • State Hospital Leoben

    Leoben, Styria, 8700

  • Hospital BHS Linz

    Linz, Upper Austria, 4010

  • General Hospital Linz

    Linz, Upper Austria, 4020

  • Hospital Oberpullendorf

    Oberpullendorf, Burgenland, 7350

  • Hospital Oberwart

    Oberwart, Burgenland, 7400

  • State Hospital Feldkirch/Rankweil

    Rankweil, Vorarlberg, 6807

  • Ordination Dr. Wette

    Saint Veit A. D. Glan, Carinthia, 9300

  • Hospital BHB St. Veit/Glan, Surgery

    Saint Veit A. D. Glan, Carinthia, 9330

  • Paracelsus Medical University Salzburg - Oncology

    Salzburg, State of Salzburg, 5020

  • State Hospital Steyr

    Steyr, Upper Austria, 4400

  • Medical University Vienna, General Hospital

    Vienna, State of Vienna, 1090

  • State Hospital Vienna-Hietzing

    Vienna, State of Vienna, 1130

  • Hanusch Hospital

    Vienna, State of Vienna, 1140

  • State Hospital Villach

    Villach, Carinthia, 9500

  • Klinikum Wels-Grieskirchen

    Wels, Upper Austria, 4600

  • Hospital of Wiener Neustadt

    Wiener Neustadt, Lower Austria, 2700

  • State Hospital Wolfsberg

    Wolfsberg, Carinthia, 9400

Other trials in Austria

About this study

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

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).

Read the 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.

Conditions
Breast Cancer
Keywords
Epirubicin, Docetaxel, Capecitabine, Herceptin, Breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpirubicinDrug

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

  • DocetaxelDrug

    Also called Taxotere

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

  • CapecitabineDrug

    Also called Xeloda

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

  • TrastuzumabDrug

    Also called Herceptin

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

Study groups in NCT00309556
Study groupRoleWhat they receive
A (experimental group)Active comparatorEpirubicin/Docetaxel/Capecitabine-containing chemotherapy ± trastuzumab in HER-2 positive disease
Receives: Drug: Epirubicin; Drug: Docetaxel; Drug: Capecitabine; Drug: Trastuzumab
B (control group)Active comparatorEpirubicin/Docetaxel-containing chemotherapy ± trastuzumab in HER-2 positive disease
Receives: Drug: Epirubicin; Drug: Docetaxel; Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 20 weeks

Secondary outcomes (1)

  1. Rates of axillary lymph node involvement and breast-conserving procedures

    at the time of final surgery in Arm A (± trastuzumab in HER-2 positive disease) vs. Arm B (± trastuzumab in HER-2 positive disease).

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2006 (estimated)
  2. Study startFeb 2005
  3. Primary completionNov 2009
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
536 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00309556
Sponsor's protocol ID
ABCSG-24
Other IDs
Ro 09-1978
Status last verified
Dec 2011
First submitted
31 Mar 2006
Last updated
30 Dec 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34037241

  • 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.

    PubMed 24347519

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epirubicin, Docetaxel and Capecitabine in people with Breast Cancer, run by Austrian Breast & Colorectal Cancer Study Group at 26 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of pathological complete remissions (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00309556, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2011.

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