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Efficacy and safety of neoadjuvant CEX-XT treatment for triple-negative breast cancer

Efficacy and safety of neoadjuvant CEX-XT treatment for triple-negative breast cancer - NeoXX trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006946
Enrollment
40
Registered
2012-01-01
Start date
2012-01-01
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

Triple-negative breast cancer

Interventions

cyclophosphamide, epirubicin, capecitabine, docetaxel

Sponsors

Department of breast and endocrine surgery, Hyogo college of medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed breast cancer aged between 20-70 years old female 2. Operable stage I-III (TNM) breast cancers 3. Estrogen receptor negative 4. Progesterone receptor negative 5. HER 2 negative: either 0, 1, 2 expression by IHC and FISH-negative 6. No prior treatment for breast cancer including chemotherapy, radiotherapy, endocrine therapy, immunotherapy 7. PS: 0-1 (ECOG) 8. Signed written informed consent

Exclusion criteria

Exclusion criteria: 1. Another cancer diagnosed within 5 years 2. Pregnant or nursing women 3. Male patients 4. With history of serious drug allergy 5. With interstitial pneumonitis or lung fibrosis 6. Infection or possible infection associated with clinical symptoms such as fever 7. With symptom of varicella 8. With uncontrollable pleural effusion, or pericardial effusion 9. With severe edema 10. With severe peripheral neuropathy 11. Usual treatment with steroid 12. With severe psychological complication 13. Bilateral breast cancer 14. Cases who physician judged improper to entry this trial

Design outcomes

Primary

MeasureTime frame
Pathological complete response

Secondary

MeasureTime frame
Clinical response, breast conserving rate, safety, DFS, OS

Countries

Japan

Contacts

Public ContactYasuo Miyoshi

Hyogo college hospital Department of breast and endocrine surgery

ymiyoshi@hyo-med.ac.jp0798-45-6374

Outcome results

None listed

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