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Phase II Clinical Study of Bevacizumab in Combination With Capecitabine as First-line Treatment in Elderly Patients With Metastatic Breast Cancer

Phase 2
70 Years
Open (Enrolling)
Breast Cancer, Metastasis

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Trial Information

Phase II Clinical Study of Bevacizumab in Combination With Capecitabine as First-line Treatment in Elderly Patients With Metastatic Breast Cancer

Inclusion Criteria:

- Signed informed consent obtained prior to initiation of any study specific procedures
and treatment as confirmation of the patient's awareness and willingness to comply
with the Protocol code: ML22373 Protocol SEEROG: version 1.2. Date: October 15, 2009
3 study requirements;

- Age ≥70 years;

- Pathologically confirmed and documented metastatic breast cancer or locally recurrent
breast cancer not amenable to curative treatment. Complete radiology and tumor
measurement workup must be completed within 4 weeks prior to first study treatment;

- Measurable disease according to RECIST criteria;

- HER2 negative disease;

- No prior treatment for metastatic or locally recurrent disease;

- Prior radiotherapy is allowed if delivered at least 2 weeks before enrolment in the
study and for the relief of metastatic bone pain, and provided that no more than 30%
of marrow bearing bone was irradiated and that target lesions were not included in
the radiotherapy field;

- Not suitable for aggressive chemotherapy regimen in the opinion of the investigator;

- Performance status ECOG 0 - 2.

Exclusion Criteria:

- Any prior neoadjuvant or adjuvant treatment with anthracyclines completed less than 6
months prior to enrolment. The maximum cumulative dose received must not have
exceeded 360 mg/m2 for doxorubicin or 720 mg/m2 for epirubicin. Prior anti-epidermal
growth factor therapy is allowed;

- Concurrent hormonal therapy; however previous hormonal therapy is allowed for
adjuvant, locally recurrent, or metastatic breast cancer if completed within ≥1
months prior to enrolment;

- History or clinical evidence of brain metastases. If there is any clinical suspicion
of brain metastasis, a computerized tomography (CT) scan or magnetic resonance
imaging (MRI) of the brain must be conducted within 4 weeks prior to enrolment;

- Other malignancy (including primary brain tumors) within the Protocol code: ML22373
Protocol SEEROG: version 1.2. Date: October 15, 2009 4 last 5 years, which could
affect the diagnosis or assessment of breast cancer, except for adequately treated
carcinoma in situ of the cervix, squamous carcinoma of the skin, or adequately
controlled limited basal cell skin cancer;

- Life expectancy < 12 weeks;

- Any of the following abnormal values:

- Inadequate bone marrow function: hemoglobin (Hb) < 8.0 g/dL, absolute neutrophil
count (ANC) < 1.5 x 109/L, or platelet count < 100 x 109/L;

- Inadequate liver function: AST/SGOT or ALT/SGPT > 2.5 x upper limit of normal
(ULN) or > 5 x ULN in patients with liver metastases), serum alkaline
phosphatase > 2.5 ULN or > 5 x ULN in patients with liver metastases, or > 10 x
ULN in patients with bone metastases or total bilirubin > 2 x ULN;

- Moderate or severe renal impairment: creatinine clearance ≤50 mL/min (calculated
according to the cockcroft and Gault formula; see Appendix 1), or serum
creatinine > 1.5 x ULN;

- Chronic daily treatment with aspirin (> 325 mg/day) or clopidogrel (> 75 mg / day);

- Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone
equivalent) (excluding inhaled steroids);

- Requirement for concurrent use of the antiviral agents sorivudine or brivudine;

- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to enrolment, or anticipation of the need for major surgery during the course
of the study treatment;

- Minor surgical procedures, within 24 hours prior to enrolment;

- Current or recent (within the 30 days prior to starting study treatment) treatment
with another investigational drug or participation in another investigational study.

- Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or
clinically significant (i.e. active) cardiovascular disease, including:

- Cerebrovascular accident/stroke (≤ 6 months prior to enrolment)

Type of Study:


Study Design:

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

Outcome Measure:

Time to treatment progression

Outcome Description:

followed until death

Outcome Time Frame:

average 5 years

Safety Issue:


Principal Investigator

Eduard Vrdoljak, PhD MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinical Hospital Split, Center of oncology, Croatia


Croatia: Ethics Committee

Study ID:




Start Date:

May 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastasis
  • metastatic breast cancer
  • elderly patients
  • chemoimmunotherapy
  • Triple negative metastatic breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis