Mono Efficacy of Capecitabine (MoniCa)

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
German Breast Group
ClinicalTrials.gov Identifier:
NCT00196820
First received: September 12, 2005
Last updated: October 5, 2011
Last verified: May 2008
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by German Breast Group:

Primary Outcome Measures:
  • Any progression of disease or disease related death of a patient [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any response (partial and complete) documented according to the WHO Criteria (s. App 6), [ Designated as safety issue: No ]
  • Time from complete or partial response until progression of disease or death due to any cause, [ Designated as safety issue: No ]
  • Any response (partial and complete) and stable disease of > 24 weeks duration documented according to the WHO Criteria (App. 6), [ Designated as safety issue: No ]
  • Any grade III/IV toxicity (NCI-CTC Version 2.0), [ Designated as safety issue: Yes ]
  • Premature treatment discontinuation, [ Designated as safety issue: Yes ]
  • Any dose reduction due to toxicity, [ Designated as safety issue: Yes ]
  • Any death of a patient, [ Designated as safety issue: Yes ]
  • EORTC QoL and modified Brunner Score, [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2005
Study Completion Date: December 2008
Arms Assigned Interventions
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

Detailed Description:

Study design:

Prospective, open phase II trial

Treatment:

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

  Eligibility

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

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.
  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: NCT00196820

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

Additional Information:
No publications provided

Responsible Party: German Breast Group
ClinicalTrials.gov Identifier: NCT00196820     History of Changes
Other Study ID Numbers: GBG 39, Eudract Number: 2005-000074-51
Study First Received: September 12, 2005
Last Updated: October 5, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014