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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00288002
First received: February 6, 2006
Last updated: August 23, 2013
Last verified: July 2009
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathologic complete response [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: January 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  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: NCT00288002

Locations
Germany
Universitaetsfrauenklinik Frankfurt
Neu-Isenburg, Germany, D-63263
Sponsors and Collaborators
German Breast Group
Investigators
Principal Investigator: Gunter von Minckwitz, MD German Breast Group
  More Information

Additional Information:
Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00288002     History of Changes
Other Study ID Numbers: CDR0000455125, GBG-GEPARQUATTRO, GBG-40, EU-205101, AVENTIS-GBG-GEPARQUATTRO, ROCHE-AVENTIS-GBG-GEPARQUATTRO, EUDRACT-2005-001546-17
Study First Received: February 6, 2006
Last Updated: August 23, 2013
Health Authority: Unspecified

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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Capecitabine
Trastuzumab
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on October 19, 2014