Breast CancerPhase 2NCT01195298
Bevacizumab and Capecitabine in Treatment of Elderly Patients With Metastatic Breast Cancer
A Phase 2 study testing Capecitabine and Bevacizumab in people with Breast Cancer and Metastasis, run by South Eastern European Research Oncology Group at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Breast Cancer, Metastasis
- What is being tested?
- Capecitabine and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 88 participants
- Where
- 1 siteCroatia
- Study dates
- May 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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:
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- 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)
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Split, Center of oncology
Split, 21000
Eduard Vrdoljak, PhD MD, 00385-21-556-129, eduard.vrdoljak@st.htnet.hr
Eduard Vrdoljak, PhD MD
About this study
Official title: 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.
- Conditions
- Breast Cancer, Metastasis
- Being tested
- Capecitabine and Bevacizumab
- Keywords
- metastatic breast cancer, elderly patients, chemoimmunotherapy, Triple negative metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine and BevacizumabDrug
Also called Bevacizumab (Avastin ), Capecitabine (Xeloda)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment progression
followed until death
Measured: average 5 years
Secondary outcomes (4)
overall response rate in patients with measurable disease at baseline
Measured: average 5 years
safety and tolerability
Measured: average 5 years
Clinical benefit (complete response, partial response and stable disease) in patients with measurable disease at baseline
Measured: average 5 years
progression-free survival
Measured: average 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Eastern European Research Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Eduard Vrdoljak, PhD MD, Principal investigator, Clinical Hospital Split, Center of oncology, CroatiaDamir Vrbanec, PhD MD, Principal investigator, Clinical Hospital Zagreb, CroatiaKatarina Petrakova, MD, Principal investigator, Masaryk Memorial Cancer Institue, Brno, Czech RepublicGyorgy Bodoky, PhD MD, Principal investigator, FOVAROSI SZENT LASZLO KORHAZ-RENDELOINTEZET, ONKOLOGIAI OSZTALY, Budapest, HungaryTamas Pinter, MD, Principal investigator, Petz, Aladar Korhaz, Onkoradiologiai Osztaly, Gyor, HungaryVladimir Todorović, MD, Principal investigator, Oncology clinic, Clinical Center of MontenegroMarek Wojtukiewicz, PhD MD, Principal investigator, Department of Oncology Medical University, Bialystok, PolandTadeusz Pienkowski, PhD MD, Principal investigator, Cancer Centre and Institute of Oncology Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195298
- Sponsor's protocol ID
- ML22373
- Status last verified
- Aug 2010
- First submitted
- 26 Aug 2010
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Bevacizumab in Combination With Capecitabine as First-line Treatment in Elderly Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01195298
- Acronym / sponsor ID
- ML22373
- Conditions
- Breast Cancer, Metastasis
- Keywords
- metastatic breast cancer, elderly patients, chemoimmunotherapy, Triple negative metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- South Eastern European Research Oncology GroupUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- May 2010
- Primary completion
- Aug 2011 (estimated)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine and BevacizumabAlso: Bevacizumab (Avastin ), Capecitabine (Xeloda)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. | Drug | – |
Primary outcome
Time to treatment progression
Time frame: average 5 years
followed until death
4 secondary outcomes
overall response rate in patients with measurable disease at baseline
Time frame: average 5 years
safety and tolerability
Time frame: average 5 years
Clinical benefit (complete response, partial response and stable disease) in patients with measurable disease at baseline
Time frame: average 5 years
progression-free survival
Time frame: average 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Hospital Split, Center of oncology
Split, Croatia
Eduard Vrdoljak, PhD MD principal investigator
Clinical Hospital Split, Center of oncology, Croatia
Damir Vrbanec, PhD MD principal investigator
Clinical Hospital Zagreb, Croatia
Katarina Petrakova, MD principal investigator
Masaryk Memorial Cancer Institue, Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine and Bevacizumab in people with Breast Cancer and Metastasis, run by South Eastern European Research Oncology Group at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment progression (time frame: average 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2010.