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Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer

Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer - Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011860
Enrollment
380
Registered
2013-10-01
Start date
2012-12-28
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

UFT TS-1

Sponsors

Breastopia Namba Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Women with a histopathological diagnosis of invasive breast cancer 2) Curative surgery was performed for an initial diagnosis of stage I to IIIA or stage IIIB breast cancer 3) HER2-negative breast cancer 4) Moderate or high risk of recurrence 5) If preoperative chemotherapy, preoperative endocrine therapy, or postoperative chemotherapy was given as previous treatment, The case that follows the regimen that was established in protocol 6) If postoperative endocrine therapy was being received, The case that follows the regimen that was established in protocol 7) If the conserved breast, thoracic wall, or regional lymph nodes underwent radiotherapy, at least 2 weeks have elapsed since the completion of treatment. 8) Within one year after surgery and within 6 months after the start of postoperative endocrine therapy 9) Age more than 20 years old , and signed informed consent of the patient for the registration. 10) ECOG performance status is 0 to 1 11) Oral intake is possible

Exclusion criteria

Exclusion criteria: 1) Active double cancer 2) Bilateral (synchronous or asynchronous) breast cancer, inflammatory breast cancer 3) A history of previous treatment with oral 5-fluorouracil derivatives for 2 weeks or longer (Patients who received intravenous 5-fluorouracil can be enrolled.) 4) Serious diarrhea 5) Others, Serious complications 6) Pregnant women, nursing women, or women who want to become pregnant 7) Patients judged to be unsuitable for enrollment in the study by their physicians

Design outcomes

Primary

MeasureTime frame
Primary endpoint : disease-free survival

Secondary

MeasureTime frame
Secondary endpoint :overall survival, relapse-free survival, relative dose intensity, and safety

Countries

Japan

Contacts

Public ContactKatsunori abe

Breastopia Namba Hospital Breast Surgical oncology

k.abe@breastopia.org0985-32-7177

Outcome results

None listed

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