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Combination Chemotherapy With or Without Capecitabine and/or Trastuzumab Before Surgery in Treating Women With Stage I, Stage II, or Stage III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00288002
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving monoclonal antibodies after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without capecitabine and/or trastuzumab in treating breast cancer.

PURPOSE: This randomized phase III trial is studying epirubicin, cyclophosphamide, and docetaxel to compare how well they work with or without capecitabine and/or trastuzumab before surgery in treating women with stage I, stage II, or stage III breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Drug: capecitabine Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Exploring the Efficacy of Capecitabine Given Concomitantly or in Sequence to EC-Doc With or Without Trastuzumab as Neoadjuvant Treatment of Primary Breast Cancer
Study Start Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Pathologic complete response

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed unilateral or bilateral primary breast cancer

    • Meets 1 of the following staging criteria:

      • Clinical stage T4 or T3 disease
      • Clinical stage T1 and pathologic stage N+ by sentinel lymph node biopsy OR clinical stage T2, N+ disease AND estrogen receptor (ER) or progesterone receptor (PR) positive tumor
      • ER and PR negative tumor (T1-4, N0-3, M0)
  • Disease confirmed by core biopsy

    • No fine-needle aspiration or incisional biopsy
  • Bidimensionally measurable disease*

    • Tumor lesion palpable and measures ≥ 2 cm OR tumor lesion ≥ 1 cm in maximum diameter by sonography

      • For inflammatory disease, extent of inflammation can be used as measurable lesion NOTE: *In patients with multifocal or multicentric breast cancer, the largest lesion should be measured
  • Candidate for adjuvant chemotherapy

    • No low- or moderate-risk patients who are doubtful candidates for adjuvant chemotherapy and do not fulfill the staging criteria
  • Known HER-2/neu status by core biopsy

    • HER-2/neu positive tumor is defined as +3 by immunohistochemistry [IHC] OR positive by fluorescence in situ hybridization (FISH)
  • No evidence of distant metastasis
  • Hormone receptor status:

    • ER- or PR-positive tumor OR ER- and PR-negative tumor


  • No male patients
  • Menopausal status not specified
  • Karnofsky performance status 80-100%
  • Life expectancy ≥ 10 years (disregarding diagnosis of cancer)
  • Normal cardiac function confirmed by ECG
  • LVEF ≥ 55% by cardiac ultrasound
  • Neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase (AP) ≤ 5 times ULN OR
  • AP ≤ 2.5 times ULN AND AST and/or ALT ≤ 1.5 times ULN
  • Creatinine ≤ 2 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No motor or sensory neuropathy ≥ grade 2
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No New York Heart Association class II-IV congestive heart failure
  • No coronary artery disease
  • No history of myocardial infarction
  • No uncontrolled arterial hypertension (i.e., blood pressure ≥ 160/90 mm Hg despite antihypertensive therapy)
  • No rhythm abnormalities requiring permanent therapy
  • No history of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude giving informed consent
  • No active infection
  • No active peptic ulcer
  • No unstable diabetes mellitus or insulin-dependent type II diabetes mellitus
  • No other serious illness or medical condition
  • No known hypersensitivity reaction to investigational compounds or incorporated substances
  • No definite contraindications for the use of corticosteroids
  • No known dihydropyrimidine dehydrogenase deficiency
  • Must be fit for anthracycline/taxane-containing chemotherapy


  • No prior chemotherapy for any malignancy
  • No prior radiation therapy for breast cancer
  • No concurrent bisphosphonates during chemotherapy

    • Bisphosphonates allowed postoperatively
  • No chronic treatment with corticosteroids unless it is initiated > 6 months prior to study entry and is given at low doses (≤ 20 mg methylprednisolone or equivalent)
  • No concurrent amifostine during chemotherapy
  • No concurrent cardioprotectors (e.g., dexrazoxane) during chemotherapy
  • No concurrent sex hormone therapy
  • No concurrent virostatic agents (e.g., sorivudine or brivudine)
  • No concurrent aminoglycosides
  • No other concurrent experimental drugs or anticancer therapy
  • At least 30 days since prior participation in another clinical trial with any investigational (not marketed) drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00288002

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Universitaetsfrauenklinik Frankfurt
Neu-Isenburg, Germany, D-63263
Sponsors and Collaborators
German Breast Group
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Principal Investigator: Gunter von Minckwitz, MD German Breast Group
Publications of Results:
Riethdorf S, Loibl S, Komor M, et al.: Incidence and kinetics of circulating tumor cells in breast cancer patients treated with primary systemic therapy including trastuzumab for patients with HER2-positive tumors a translational project within the study GeparQuattro. [Abstract] Breast Cancer Res Treat 106 (1): A-5025, S214, 2007.
von Minckwitz G, Rezai M, Loibl S, et al.: Evaluating the efficacy of capecitabine given concomitantly or in sequence to epirubicin/cyclophosphamide docetaxel as neoadjuvant treatment for primary breast cancer. First efficacy analysis of the GBG/AGO intergroup-study GeparQuattro. [Abstract] Breast Cancer Res Treat 106 (1): A-79, S21-2, 2007.

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00288002    
Other Study ID Numbers: CDR0000455125
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
inflammatory breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IA breast cancer
stage IB breast cancer
estrogen receptor-negative breast cancer
estrogen receptor-positive breast cancer
HER2-negative breast cancer
HER2-positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites, Antineoplastic
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors