Evaluation of effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer:A multicenter phase2 study

Evaluation of effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer:A multicenter phase2 study - Evaluation of effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer:A multicenter phase2 study(KBCSG0407 X-mono)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000260

Enrollment

Registered

2005-10-10

Start date

2004-11-01

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

Metastatic Breast Cancer

Interventions

Chemotherapy (Capecitabine 1657mg/m2 day1-21,q4w)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Metastatic breast cancer 2) ECOG PS 0-1 3) Measurable disease as per RECIST criteria 4) No prior chemotherapy to targeted lesion 5) have Anthracycline-based regimen for pre or postoperative settings 6) Adequate bone marrow,hepatic,renal,cardiac functions 7) expected survival time: more than 6 months 8) Written informed concent

Exclusion criteria

Exclusion criteria: 1) have capecitabine before 2) Hypersensitivity to drugs 3) severe complication 4) active double cancer 5) in pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Response rete	—

Secondary

Measure	Time frame
Clinical benefit rete, Progression-free survival, Overall survival, Safety profiles	—

Countries

Japan

Contacts

Public ContactShinzaburo Noguchi

KBCSG (Kinki Breast Cancer Study Group) Executive Office

06-6879-3772

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026