NCT01196455

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

September 8, 2010

Status Verified

August 1, 2010

Enrollment Period

5.1 years

First QC Date

August 31, 2010

Last Update Submit

September 7, 2010

Conditions

Breast CancerMetastasis

Keywords

Metastatic breast cancer patients

Outcome Measures

Primary Outcomes (1)

  • Response rate

    average 5 years

Secondary Outcomes (3)

  • time to disease progression

    average 5 years

  • overall survival

    average 5 years

  • Toxicity

    average 5 years

Interventions

Capecitabine and Mitomycin CDRUG

* 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

Also known as: Capecitabine (Xeloda), Mitomycin C (Mutamycin)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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 \[creatinine clearance \< 30 mL/min (calculated according to cockcroft and Gault)\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of oncology

Split, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

CapecitabineMitomycin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Eduard Vrdoljak, MD PhD

    Clinical Hospital Split, Center of oncology, Croatia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduard Vrdoljak, PhD MD

CONTACT

00385-21-556-129eduard.vrdoljak@st.htnet.hr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 8, 2010

Study Start

March 1, 2006

Primary Completion

April 1, 2011

Last Updated

September 8, 2010

Record last verified: 2010-08

Locations

CR(1)