Breast CancerPhase 2NCT00196820
Mono Efficacy of Capecitabine (MoniCa)
A Phase 2 study testing Capecitabine in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.
Trial summary
Study done in patients with metastatic breast cancer in order to determine the efficacy of capecitabine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2005to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Histologically confirmed carcinoma of the breast.
- Negative for HER2-overexpression of the primary and/or metastatic tumour tissue detected by immunohistochemistry (DAKO 0-2) or genamplification detected by FISH.
- Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
- 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)
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- Patients must have either measurable or nonmeasurable target lesions according to the WHO criteria (see Appendix 5).
- 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.
- Complete radiology and tumor measurement work up within 4 weeks prior to registration.
- Karnofsky performance status evaluation > or = 60%
- Age >18 years
- WBC > or = 3000 cells/microl, platelet count > or = 100,000 cells/microl.
- 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 metastases.
- Creatinine < or = 1,25 x upper normal value or creatinin-clearance > 50 ml/min (according to Cockroft Gault).
- 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.
- Female and male patients
Who cannot join
- Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
- Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and discontinuation of all steroids.
- Life expectancy of less than 3 months.
- Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
- History of other malignancy within the last 5 years which could affect the diagnosis or assessment of metastatic breast cancer.
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- Patients with indication for polychemotherapy.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
- Treatment with sorivudine or derivates e.g. brivudin.
- Pregnant or nursing women.
Trial locations and contacts
1 site in 1 country.
Germany1 site
J. W. Goethe Universität, Frauenklinik
Frankfurt am Main, Hesse, 60590
About this study
Official title: 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 done in patients with metastatic breast cancer in order to determine the efficacy of capecitabine
Read the detailed description
Study design:
Prospective, open phase II trial
Treatment:
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
- To determine the objective response rate
- To determine the duration of response
- To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks
- To evaluate the safety and toxicity of capecitabine
- To assess quality of life within 1 year after start of capecitabine treatment
- To determine overall survival
- To determine the objective response rate in male patients
- To evaluate QoL the modified Brunner Score (Appendix 7 )
Tertiary objective
To determine the DPD and Proteomics in serum
- Conditions
- Breast Cancer
- Being tested
- Capecitabine
- Keywords
- Metastatic breast cancer, HER2 negative, medium-risk, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Capecitabine 2000 mg/m2 orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any progression of disease or disease related death of a patient
Secondary outcomes (8)
Any response (partial and complete) documented according to the WHO Criteria (s. App 6),
Time from complete or partial response until progression of disease or death due to any cause,
Any response (partial and complete) and stable disease of > 24 weeks duration documented according to the WHO Criteria (App. 6),
Any grade III/IV toxicity (NCI-CTC Version 2.0),
Premature treatment discontinuation,
Any dose reduction due to toxicity,
Any death of a patient,
EORTC QoL and modified Brunner Score,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2005
- Study completionDec 2008
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GBG Forschungs GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Manfred Kaufmann, MD, Principal investigator, Klinikum der J. W. Goethe Universität, Universitätsfrauenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196820
- Sponsor's protocol ID
- GBG 39
- Other IDs
- Eudract Number: 2005-000074-51
- Status last verified
- May 2008
- First submitted
- 12 Sep 2005
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00196820
- Acronym / sponsor ID
- GBG 39
- Conditions
- Breast Cancer
- Keywords
- Metastatic breast cancer, HER2 negative, medium-risk, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GBG Forschungs GmbHUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jul 2005
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Sep 2005 (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.
Study done in patients with metastatic breast cancer in order to determine the efficacy of capecitabine
Detailed description
Study design:
Prospective, open phase II trial
Treatment:
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
- To determine the objective response rate
- To determine the duration of response
- To determine the clinical benefit defined as CR, PR, or stable disease ≥ 24 weeks
- To evaluate the safety and toxicity of capecitabine
- To assess quality of life within 1 year after start of capecitabine treatment
- To determine overall survival
- To determine the objective response rate in male patients
- To evaluate QoL the modified Brunner Score (Appendix 7 )
Tertiary objective
To determine the DPD and Proteomics in serum
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: CapecitabineCapecitabine 2000 mg/m2 orally day 1-14 q day 22 until progression, unacceptable toxicity, patient's request or withdrawal from study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Histologically confirmed carcinoma of the breast.
- Negative for HER2-overexpression of the primary and/or metastatic tumour tissue detected by immunohistochemistry (DAKO 0-2) or genamplification detected by FISH.
- Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
- The following previous systemic treatment are eligible:
Key exclusion criteria (10 listed)
- Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
- Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and discontinuation of all steroids.
- Life expectancy of less than 3 months.
- Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including AIDS and serious active infection).
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 | Drug | A |
Primary outcome
Any progression of disease or disease related death of a patient
8 secondary outcomes
Any response (partial and complete) documented according to the WHO Criteria (s. App 6),
Time from complete or partial response until progression of disease or death due to any cause,
Any response (partial and complete) and stable disease of > 24 weeks duration documented according to the WHO Criteria (App. 6),
Any grade III/IV toxicity (NCI-CTC Version 2.0),
Premature treatment discontinuation,
Any dose reduction due to toxicity,
Any death of a patient,
EORTC QoL and modified Brunner Score,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
- Click here for more information about this study: MoniCa StudyLink provided by the sponsor.
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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.
Manfred Kaufmann, MD principal investigator
Klinikum der J. W. Goethe Universität, Universitätsfrauenklinik
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 in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.
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 16 inclusion and 10 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: finished, as of the sponsor's last update on 6 Oct 2011. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any progression of disease or disease related death of a patient. 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 Oct 2011.