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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Metastasis
• Intervention / Treatment: Drug: Capecitabine and Bevacizumab

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia, 21000
    • Recruiting
    • Clinical Hospital Split, Center of oncology
    • Principal Investigator: Eduard Vrdoljak, PhD MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment progression	followed until death	average 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall response rate in patients with measurable disease at baseline	average 5 years
safety and tolerability	average 5 years
Clinical benefit (complete response, partial response and stable disease) in patients with measurable disease at baseline	average 5 years
progression-free survival	average 5 years

Collaborators and Investigators

• Sponsor: South Eastern European Research Oncology Group
• Collaborators: Roche Pharma AG
• Investigators: 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: Gyorgy Bodoky, PhD MD, FOVAROSI SZENT LASZLO KORHAZ-RENDELOINTEZET, ONKOLOGIAI OSZTALY, Budapest, Hungary; 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

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: September 3, 2010
• First Posted (Estimate): September 6, 2010

Study Record Updates

• Last Update Posted (Estimate): September 6, 2010
• Last Update Submitted That Met QC Criteria: September 3, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: metastatic breast cancer; elderly patients; Triple negative metastatic breast cancer; chemoimmunotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Capecitabine; Bevacizumab
• Other Study ID Numbers: ML22373