Cohort study evaluating efficacy and safety of gemcitabine for advanced or metastatic breast cancer (YCOG1005)

Cohort study evaluating efficacy and safety of gemcitabine for advanced or metastatic breast cancer (YCOG1005) - Cohort study evaluating efficacy and safety of gemcitabine for advanced or metastatic breast cancer (YCOG1005)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000013002

Enrollment

100

Registered

2014-01-29

Start date

2010-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Patients have been confirmed with breast cancer histologically or cytologically 2) ECOG preformance status (PS.): 0-2. 3) Sufficient bone marrow and major organ functions (determined by the attending physician). 4) Extent of radiation therapy being 20% or below of whole bone marrow. 5) Study treatment is the first line chemotherapy in inoperable metastatic breast cancer. 6)Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Past history of gemcitabine administration. 2) Inflamatory breast cancer 3) Pulmonary fibrosis or interstitial pneumonia. 4) Heart failure or acute myocardiac infarction within 6 months. 5) Active infection. 6) Severe complications. 7) Severe drug allergy. 8) Severe psychiatric disorder. 9) Symptomatic brain betastasis 10) Double cancer. 11) Women who are pregnant, lactating or declined contraception. 12) Gastrointestinal perforation and severe fistula

Design outcomes

Primary

Measure	Time frame
Time to Treatment failure,TTF	—

Secondary

Measure	Time frame
adverse event, QOL(FACT-B)	—

Countries

Japan

Contacts

Public ContactKazutaka Narui

Yokohama City University Medical Center Department of Breast and Thyroid Surgery

nr1@gc5.so-net.ne.jp045-261-5656

Outcome results