Breast CancerPhase 2NCT01196455
Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer
A Phase 2 study testing Capecitabine and Mitomycin C in people with Breast Cancer and Metastasis, run by Croatian Cooperative Group for Clinical Research in Oncology at 1 site in Croatia.
Trial summary
This is an open-label, non-comparative efficacy and safety study of Capecitabine and Mitomycin C as first-line treatment in patients with previously untreated metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastasis
- What is being tested?
- Capecitabine and Mitomycin C
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 39 participants
- Where
- 1 siteCroatia
- Study dates
- Mar 2006to Apr 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically confirmed breast cancer
- Metastatic breast cancer, having at least one target lesion according to the RECIST criteria. Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, inflammatory breast disease, lymphangitic spread or cystic lesions are not acceptable as target lesions. Target lesions must be ≥ 10 mm longest diameter measured in one dimension using spiral CT, or ≥ 20 mm longest diameter measured in one dimension using conventional techniques. In addition to the definitions pertaining to the target lesion(s) from the RECIST criteria above, the target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
- Age > 18 years
- Signed informed consent obtained prior to initiation of any study-specific procedures or treatment
Who cannot join
- Prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
- Prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
- Life expectancy < 3 months
- Not-ambulatory or with an ECOG performance status > 1
- Insufficient hematological, renal and hepatic functions:
- hemoglobin < 8.0 g/dL
Show all 13Show fewer
- absolute neutrophils count (ANC) < 1.5 x 109/L
- platelet count < 100 x 109/L
- serum creatinine > 1.25 x N*
- total bilirubin > 2.0 x N*
- ASAT and/or ALAT > 2.5 x N* (in case of liver metastases > 5 x N*)
- alkaline phosphatase > 2.5 x N* (in case of liver metastases > 5 x N*, in case of bone metastases > 10 x N*) *N = upper limit of standard range
- Severe renal impairment [creatinine clearance < 30 mL/min (calculated according to cockcroft and Gault)]
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Center of oncology
Split, 21000
Eduard Vrdoljak, MD PhD, 00385-21-556-129, eduard.vrdoljak@st.htnet.hr
About this study
Official title: Phase II Clinical Study of Capecitabine in Combination With Mitomycin C as First-Line Treatment in Patients With Metastatic Breast Cancer
This is an open-label, non-comparative efficacy and safety study of Capecitabine and Mitomycin C as first-line treatment in patients with previously untreated metastatic breast cancer.
- Conditions
- Breast Cancer, Metastasis
- Being tested
- Capecitabine and Mitomycin C
- Keywords
- Metastatic breast cancer patients
- 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 Mitomycin CDrug
Also called Capecitabine (Xeloda), Mitomycin C (Mutamycin)
- Capecitabine 1000 mg/m2 twice-daily, administered orally on day 1-14, every three weeks
- Mitomycin C 8 mg/m2 i.v. bolus, on day 1, every three weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: average 5 years
Secondary outcomes (3)
time to disease progression
Measured: average 5 years
overall survival
Measured: average 5 years
Toxicity
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 posted8 Sep 2010 (estimated)
- Study startMar 2006
- Primary completionApr 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Croatian Cooperative Group for Clinical Research in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Eduard Vrdoljak, MD PhD, Principal investigator, Clinical Hospital Split, Center of oncology, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196455
- Sponsor's protocol ID
- MO18646
- Status last verified
- Aug 2010
- First submitted
- 31 Aug 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Capecitabine in Combination With Mitomycin C as First-Line Treatment in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01196455
- Acronym / sponsor ID
- MO18646
- Conditions
- Breast Cancer, Metastasis
- Keywords
- Metastatic breast cancer patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Croatian Cooperative Group for Clinical Research in OncologyUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Mar 2006
- Primary completion
- Apr 2011 (estimated)
- First posted
- 8 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, non-comparative efficacy and safety study of Capecitabine and Mitomycin C as first-line treatment in patients with previously untreated metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically/cytologically confirmed breast cancer
- Metastatic breast cancer, having at least one target lesion according to the RECIST criteria. Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, inflammatory breast disease, lymphangitic spread or cystic lesions are not acceptable as target lesions. Target lesions must be ≥ 10 mm longest diameter measured in one dimension using spiral CT, or ≥ 20 mm longest diameter measured in one dimension using conventional techniques. In addition to the definitions pertaining to the target lesion(s) from the RECIST criteria above, the target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
- Age > 18 years
- Signed informed consent obtained prior to initiation of any study-specific procedures or treatment
Key exclusion criteria (13 listed)
- Prior cytotoxic chemotherapy or active/passive immunotherapy for metastatic breast disease
- Prior usage of capecitabine or mitomycin as adjuvant or neoadjuvant treatment
- Life expectancy < 3 months
- Not-ambulatory or with an ECOG performance status > 1
- Insufficient hematological, renal and hepatic functions:
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 Mitomycin CAlso: Capecitabine (Xeloda), Mitomycin C (Mutamycin)* Capecitabine 1000 mg/m2 twice-daily, administered orally on day 1-14, every three weeks * Mitomycin C 8 mg/m2 i.v. bolus, on day 1, every three weeks | Drug | – |
Primary outcome
Response rate
Time frame: average 5 years
3 secondary outcomes
time to disease progression
Time frame: average 5 years
overall survival
Time frame: average 5 years
Toxicity
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 8 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.
Eduard Vrdoljak, MD PhD principal investigator
Clinical Hospital Split, Center of oncology, Croatia
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 Mitomycin C in people with Breast Cancer and Metastasis, run by Croatian Cooperative Group for Clinical Research in Oncology 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 4 inclusion and 13 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 8 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?
Contact Eduard Vrdoljak, PhD MD (00385-21-556-129, eduard.vrdoljak@st.htnet.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (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 8 Sep 2010.