A Phase II Study of Capecitabine plus Paclitaxel Combination Chemotherapy in Patients with Metastatic Breast Cancer

A Phase II Study of Capecitabine plus Paclitaxel Combination Chemotherapy in Patients with Metastatic Breast Cancer - KBCSG 0609 XP PhaseII

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000869

Enrollment

Registered

2007-10-30

Start date

2006-05-01

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, Paclitaxel 80mg/m2, day1,8,15, q4w)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Metastatic breast cancer 2) Measurable disease as per RECIST criteria 3) ECOG PS 0-1 4) 1 or less prior chemotherapy to metastatic breast cancer 5) Adequate bone marrow,hepatic,renal,cardiac functions 6) Expected survival time: more than 3 months 7) Written informed concent

Exclusion criteria

Exclusion criteria: 1) Have Capecitabine before 2) Have Paclitaxel for metastatic lesion before 3) Hypersensitivity to drugs 4) active double cancer 5) severe complication 6) in pregnancy or lactation 7) Symptomatic brain metastasis

Design outcomes

Primary

Measure	Time frame
Response rete	—

Secondary

Measure	Time frame
Time to treatment failure, 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