Mono Efficacy of Capecitabine (MoniCa)

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: NCT00196820
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 6, 2011
Hoffmann-La Roche
Information provided by (Responsible Party):
German Breast Group

Brief Summary:
Study done in patients with metastatic breast cancer in order to determine the efficacy of capecitabine

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Capecitabine Phase 2

Detailed Description:

Study design:

Prospective, open phase II trial


Capecitabine 2000 mg/m² orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study

Primary objective

To determine the time to disease progression in patients with HER2 negative metastatic breast cancer after 1st line monochemotherapy with capecitabine

Secondary objectives

  1. To determine the objective response rate
  2. To determine the duration of response
  3. To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks
  4. To evaluate the safety and toxicity of capecitabine
  5. To assess quality of life within 1 year after start of capecitabine treatment
  6. To determine overall survival
  7. To determine the objective response rate in male patients
  8. To evaluate QoL the modified Brunner Score (Appendix 7 )

Tertiary objective

To determine the DPD and Proteomics in serum

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study to Determine the Efficacy of Capecitabine as First Line Monochemotherapy in Patients With HER2 Negative, Medium-risk, Metastatic Breast Cancer
Study Start Date : July 2005
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Capecitabine 2000 mg/m2 orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study
Drug: Capecitabine

Primary Outcome Measures :
  1. Any progression of disease or disease related death of a patient

Secondary Outcome Measures :
  1. Any response (partial and complete) documented according to the WHO Criteria (s. App 6),
  2. Time from complete or partial response until progression of disease or death due to any cause,
  3. Any response (partial and complete) and stable disease of > 24 weeks duration documented according to the WHO Criteria (App. 6),
  4. Any grade III/IV toxicity (NCI-CTC Version 2.0),
  5. Premature treatment discontinuation,
  6. Any dose reduction due to toxicity,
  7. Any death of a patient,
  8. EORTC QoL and modified Brunner Score,

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

Inclusion Criteria:

  1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
  2. Histologically confirmed carcinoma of the breast.
  3. Negative for HER2-overexpression of the primary and/or metastatic tumour tissue detected by immunohistochemistry (DAKO 0-2) or genamplification detected by FISH.
  4. Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
  5. The following previous systemic treatment are eligible:

    adjuvant chemotherapy (except if capecitabine was included) adjuvant endocrine therapy palliative endocrine treatments treatment with bisphosphonates (adjuvant and/or palliative) treatment with immunotherapies (adjuvant and/or palliative)

  6. Patients must have either measurable or nonmeasurable target lesions according to the WHO criteria (see Appendix 5).
  7. At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease.
  8. Complete radiology and tumor measurement work up within 4 weeks prior to registration.
  9. Karnofsky performance status evaluation > or = 60%
  10. Age >18 years
  11. WBC > or = 3000 cells/microl, platelet count > or = 100,000 cells/microl.
  12. Bilirubin < or = 2x the upper limit of normal for the institution (ULN); elevation of transaminases and alkaline phosphatase < 2.5x ULN or <5x ULN for patients with liver metastases.
  13. Creatinine < or = 1,25 x upper normal value or creatinin-clearance > 50 ml/min (according to Cockroft Gault).
  14. If of childbearing potential, negative pregnancy test. In addition the patient has to agree to use an effective method to avoid pregnancy for the duration of the study.
  15. Female and male patients

Exclusion Criteria:

  1. Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
  2. Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
  3. Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and discontinuation of all steroids.
  4. Life expectancy of less than 3 months.
  5. Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
  6. History of other malignancy within the last 5 years which could affect the diagnosis or assessment of metastatic breast cancer.
  7. Patients with indication for polychemotherapy.
  8. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
  9. Treatment with sorivudine or derivates e.g. brivudin.
  10. Pregnant or nursing women.

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): NCT00196820

J. W. Goethe Universität, Frauenklinik
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
German Breast Group
Hoffmann-La Roche
Principal Investigator: Manfred Kaufmann, MD Klinikum der J. W. Goethe Universität, Universitätsfrauenklinik

Additional Information:
Responsible Party: German Breast Group Identifier: NCT00196820     History of Changes
Other Study ID Numbers: GBG 39
Eudract Number: 2005-000074-51
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: May 2008

Keywords provided by German Breast Group:
Metastatic breast cancer
HER2 negative, medium-risk, metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents