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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

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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 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

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

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Any progression of disease or disease related death of a patient

Safety Issue:


Principal Investigator

Manfred Kaufmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum der J. W. Goethe Universität, Universitätsfrauenklinik


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GBG 39



Start Date:

July 2005

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • Metastatic breast cancer
  • HER2 negative, medium-risk, metastatic breast cancer
  • Breast Neoplasms