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Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in partients with metastatic breast cancer

Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in partients with metastatic breast cancer - Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in partients with metastatic breast cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006427
Enrollment
40
Registered
2011-09-28
Start date
2011-04-01
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

metastic and recurrance breast cancer

Interventions

Sponsors

Toho University Omori Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed Breast cancer 2.Inoperative metastatic or recurrent breast cancer 3.Patients with evaluable lesion 4.Age >=20 5.No prior treatment for metastatic or recurrent breast cancer 6.Sufficient organ functions Hemoglobin >=9.0g/dl WBC >=4000/mm3 Neurtophils >=2000/mm3 Platelets >=100,000/mm3 Total bilirubin <=1.5mg/dl GOT and GPT < ULNx2.5 Creatinine <1.5mg/dl 7.Performance status 0-1 8.Patients who have passed the following periods from previous treatment Endocrinetherapy:7 days from the final administration Adjuvant:6 months from the final administration 9Written IC

Exclusion criteria

Exclusion criteria: 1.Inflammatory and bilateral breast cancer 2.Active another cancer 3.History of hypersensitivity reaction 4. Other severe complications, such as pulmonary emphysema or pulmonary fibrosis, uncontrollable diabetes, heart failure, renal insufficiency, liver failure 5.Neuropathy <= grade1 6. Radiation therapy for chest 7.Serious myeloablation 8.Infection 9.Pregnant or possibility pregnancy or nursing woman 10.Physician judged improper to entry this trial

Design outcomes

Primary

MeasureTime frame
Response Rate

Secondary

MeasureTime frame
PFS,OS,Safty

Countries

Japan

Contacts

Public ContactSyunsuke Magoshi

Toho University Omori Medical Center Breast and Endocrine Surgery

magoshi@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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