The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07

The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07 - The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000504

Enrollment

Registered

2006-10-30

Start date

2005-11-28

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

Primary breast cancer

Interventions

Doxorubicin 50mg/m2, Paclitaxel 150mg/m2, q3Wx4cycles followed by paclitaxel 80mg/m2, q1Wx12cycles

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically-proven breast cancer except for inflammatory breast cancer 2. tumor diameter confirmed >=2cm and incidence of axillary metastasis 3. previously untreated with chemotherapy 4. Age >=20, <=70 5. PS(ECOG) 0-1 6. Written informed consent 7. No operation 8. Adequate organ function

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate Clinical complete response rate	—

Secondary

Measure	Time frame
Disease-free survival Overall survival Toxicity Breast conserving rate The rate of completion	—

Countries

Japan

Contacts

Public ContactToshihiro Kai

Saitama Breast Cancer Clinical Study Group (SBCCSG) Executive office

toshikai@sbccsg.org048-600-1722

Outcome results

None listed

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