Bevacizumab and Capecitabine in Treatment of Elderly Patients With Metastatic Breast Cancer

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: NCT01195298
Recruitment Status : Unknown
Verified August 2010 by South Eastern European Research Oncology Group.
Recruitment status was:  Recruiting
First Posted : September 6, 2010
Last Update Posted : September 6, 2010
Roche Pharma AG
Information provided by:
South Eastern European Research Oncology Group

Brief Summary:
This is an open-label, single-arm, multicenter study of capecitabine and bevacizumab administered as first-line treatment of previously untreated elderly patients, older than 70 years, with metastatic or locally recurrent breast cancer.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of Bevacizumab in Combination With Capecitabine as First-line Treatment in Elderly Patients With Metastatic Breast Cancer
Study Start Date : May 2010
Estimated Primary Completion Date : August 2011

Resource links provided by the National Library of Medicine

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

Intervention Details:
    Drug: Capecitabine and Bevacizumab

    Drugs will be administered in 3-week cycles as follows:

    • Bevacizumab 15mg/kg via i.v. infusion on day 1
    • Capecitabine 1000 mg/m2 tablets twice-daily, on days 1 through 14.
    Other Names:
    • Bevacizumab (Avastin )
    • Capecitabine (Xeloda)

Primary Outcome Measures :
  1. Time to treatment progression [ Time Frame: average 5 years ]
    followed until death

Secondary Outcome Measures :
  1. overall response rate in patients with measurable disease at baseline [ Time Frame: average 5 years ]
  2. safety and tolerability [ Time Frame: average 5 years ]
  3. Clinical benefit (complete response, partial response and stable disease) in patients with measurable disease at baseline [ Time Frame: average 5 years ]
  4. progression-free survival [ Time Frame: average 5 years ]

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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): NCT01195298

Clinical Hospital Split, Center of oncology Recruiting
Split, Croatia, 21000
Contact: Eduard Vrdoljak, PhD MD    00385-21-556-129   
Principal Investigator: Eduard Vrdoljak, PhD MD         
Sponsors and Collaborators
South Eastern European Research Oncology Group
Roche Pharma AG
Principal Investigator: Eduard Vrdoljak, PhD MD Clinical Hospital Split, Center of oncology, Croatia
Principal Investigator: Damir Vrbanec, PhD MD Clinical Hospital Zagreb, Croatia
Principal Investigator: Katarina Petrakova, MD Masaryk Memorial Cancer Institue, Brno, Czech Republic
Principal Investigator: Tamas Pinter, MD Petz, Aladar Korhaz, Onkoradiologiai Osztaly, Gyor, Hungary
Principal Investigator: Vladimir Todorović, MD Oncology clinic, Clinical Center of Montenegro
Principal Investigator: Marek Wojtukiewicz, PhD MD Department of Oncology Medical University, Bialystok, Poland
Principal Investigator: Tadeusz Pienkowski, PhD MD Cancer Centre and Institute of Oncology Warsaw
Principal Investigator: Daniela Grecea, MD "Prof Dr. I Chiricuta" Cluj Napoca Oncology Institute - Breast Cancer Center, Cluj Napoca, Romania

Responsible Party: Prof. dr. sc. Eduard Vrdoljak, Clinical Hospitl Split, Center of oncology Identifier: NCT01195298     History of Changes
Other Study ID Numbers: ML22373
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: August 2010

Keywords provided by South Eastern European Research Oncology Group:
metastatic breast cancer
elderly patients
Triple negative metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action