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Phase II trial of palliative intra-arterial epirubicin/5FU therapy for patients with chemotherapy-refractory locally-advanced or metastatic breast cancer

Phase II trial of palliative intra-arterial epirubicin/5FU therapy for patients with chemotherapy-refractory locally-advanced or metastatic breast cancer - JIVROSG-1107(RESAIC-II)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013242
Enrollment
30
Registered
2014-02-24
Start date
2014-02-18
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

locally-advanced and metastatic breast cancer

Interventions

RESAIC(redistributed subclavian arterial infusion chemotherapy)

Sponsors

Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with symptomatic, locally-inoperable or locally-recurrent invasive breast cancer 2)[Primary breast cancer] Prior treatment with local radiotheraly and more than three prior chemotherapyincluding an anthracycline and a taxane OR [Recurrent breast cancer] Prior treatment with local radiotheraly and more than four prior chemotherapy including an anthracycline and a taxane (including neoadjuvant/adjuvant chemotherapy) 3) Cumulative dose of anthracycline (doxorubicin) within 300mg/m2 4) Measurable lesion in the breast or on the chestwall 5) PS (ECOG) 0-2 6) Adequate organ function 7) More than 2 weeks from prior treatment

Exclusion criteria

Exclusion criteria: a)History of non-breast malignancies within the 5 years prior to study entry b)Symptomatic breast metastasis c)Concurrent serious diseases that may interfere with planned treatment d) Stenosis of subclavian artery by contrast-enhanced CT e) bilateral breast cancer or multiple lesions within the region f) Pregnant or lactating women g) Patient unfeasible for ambulatory chemotherapy

Design outcomes

Primary

MeasureTime frame
local response rate

Countries

Japan

Contacts

Public ContactMiyuki Sone

National Cancer Center Hospital Department of Radiology

msone@me.com03-3542-2511

Outcome results

None listed

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