UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response (non-pCR) after neoadjuvant chemotherapy: Phase 2 study.

UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response (non-pCR) after neoadjuvant chemotherapy: Phase 2 study. - UFT monotherapy for non-pCR patients treated with neoadjuvant chemotherapy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003835

Enrollment

Registered

2010-07-05

Start date

2010-07-01

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

UFT 270 mg/m2 (daily oral administration)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female breast cancer patients over 20 who were histologically diagnosed as primary breast cancer (invasive carcinoma). 2. Stage II-III patients who underwent curative operation. 3. Cases with histologically diagnosed residual invasive cancer after preoperative chemotherapy including anthracycline. 4. HER2 negative cases. 5. 0 to 1 ECOG performance status. 6. No carry-over effect of prior treatment. 7. Good organ function. 8. Cases with no carry-over grade 2 or more adverse drug effect. 9. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Necessary for adjuvant chemotherapies other than UFT. 2. Treated with oral 5-FU agents previously. 3. Pregnant or breastfeeding. 4. Willing for or possibilities of pregnancy. 5. Recieved the organ transplantation previously. 6. Hypersensitive or underwent severe adverse reactions to fluoropyrimidine. 7. Suffered from serious complications. 8. Having fever or possibility of the infection. 9. Metastatic breast cancer. 10. Having past history or treatment of epilepsy, central nurve system disorder, or psychiatric disease. 11. Difficulty with taking oral drugs or upper gastrointestinal function, or malabsorption syndrome. 12. Judged to be ineligible by the investigators.

Design outcomes

Primary

Measure	Time frame
feasibility	—

Secondary

Measure	Time frame
Safety, disease free survival, overall survival	—

Countries

Japan

Contacts

Public ContactSatoru Tanaka

Osaka Medical College Hospital General and gastroenterological surgery

sur112@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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