Feasibility study of weekly paclitaxel plus gemcitabine for metastatic and recurrent breast cancer with negative HER2

Feasibility study of weekly paclitaxel plus gemcitabine for metastatic and recurrent breast cancer with negative HER2 - KBC-SG1104

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007445

Enrollment

Registered

2012-03-06

Start date

2012-03-01

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

paclitaxel 80mg/m2 day1,8 gemcitabine 1250mg/m2 day1,8 every 21 days, 6 cycles

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Inoperable or recurrent breast cancer 2.HER2 negative breast cancer 3.Women aged 20 or over 4.ECOG Performance status: 0-1 5.Having measurable lesions 6.Off-therapy period prior to the study: Chemotherapy,radiation therapy >= 4 weeks Endocrine therapy >= 2 weeks 7.sufficient organ function 8.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Allergy to clemohol EL 2.Significant interstitial pneumonia or pulmonary fibrosis seen by chest radiograph and presence of symptoms associated with them 3.Pregnant or lactation women, or women with suspected pregnancy 4.Symptomatic CNS metastasis 5.Infection which needs treatment 6.Poorly controlled pleural effusion or peritoneal effusion 7.Patients judged by the investigator to be unfit for the study

Design outcomes

Primary

Measure	Time frame
response rate, safety	—

Secondary

Measure	Time frame
response duration, time to progression, overall survival	—

Countries

Japan

Contacts

Public ContactKazuo Tamura

Kyushu Breast Cancer Study Group Executive Office

npo@chotsg.com092-406-4166

Outcome results

None listed

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