Prospecitve study of radiotherapy without surgery after AC followed by weekly paclitaxel and trastuzumab for inflammatory breast cancer with HER2 over expression

Prospecitve study of radiotherapy without surgery after AC followed by weekly paclitaxel and trastuzumab for inflammatory breast cancer with HER2 over expression - Prospecitve study of radiotherapy without surgery after AC followed by weekly paclitaxel and trastuzumab for inflammatory breast cancer with HER2 over expression

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000513

Enrollment

Registered

2006-11-06

Start date

2006-11-01

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

Inflammatory breast cancer

Interventions

The chemotherapy of AC consisted of 60mg/m2 of doxorubicin and 600mg/m2 of cyclophosphamide every 21 days four cycles. Paclitaxel dose of 80 mg/m2 was given weekly for 12 weeks and trastuzumab for 52

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. clinically-proven inflammatory breast cancer with HER2 over expression 2. HER2 over expression detected by IHC (score 3+) or HER2 genetic over expression detected by FISH 3. clinically no distant metastasis 4. Age >=20, <=70 5. PS (ECOG) 0-1 6. written informed consent 7. adequate organ function

Exclusion criteria

Exclusion criteria: 1. severe complication 2. suspicious of infection 3. past history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate 4. pregnant or lactating women 5. doctor's decision for exclusion

Design outcomes

Primary

Measure	Time frame
TTP (Time To Progression)	—

Secondary

Measure	Time frame
Overall survival Toxicity Clinical response rate Pathological response rate	—

Countries

Japan

Contacts

Public ContactToshihiro Kai

Saitama Breast Cancer Clinical Study Group (SBCCSG) Executive office

toshikai@sbccsg.org048-686-7155

Outcome results

None listed

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