A feasibility study of sequential Anthracycline-based regimen and Nab-Paclitaxel / Trastuzumab followed by Trastuzumab as postoperative adjuvant chemotherapy for Her2 positive breast cancer.(SBCCSG-22)

A feasibility study of sequential Anthracycline-based regimen and Nab-Paclitaxel / Trastuzumab followed by Trastuzumab as postoperative adjuvant chemotherapy for Her2 positive breast cancer.(SBCCSG-22) - Anthracycline, Nab-Paclitaxel and Trastuzumab in the adjuvant therapy of HER-2 positive breast cancer.(SBCCSG-22)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006085

Enrollment

Registered

2011-08-01

Start date

2011-08-01

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

Primary breast cancer

Interventions

For the postoperative adjuvant chemotherapy, Anthracycline Base is done four times, and administering Nab-Paclitaxel and Trastuzumab begins. Nab-Paclitaxel is administered in a dose of 260mg/m2 by onc

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed breast cancer. 2) HER2 Overexpression (IHC 3+ or FISH +) 3) Stage I, IIA, IIB, IIIA 4) Age m than 20 years and less than 70 years. 5) ECOG performance status of 0 to 1 6) LVEF more than 55% 7) Within 6 weeks after surgery 8) Sufficient organ function 9) Required baseline laboratory parameters (within 14 days before registration): Hb more than 9.0g/dl WBC more than 3000 /mm3 Neu more than 1500 / mm3 Plt more than 100,000/mm3 AST less than 2.5 times ULN ALT less than 2.5 times ULN T-Bil less than 1.5mg/dl Cre less than 1.5mg/dl 10) Signed informed consent of the patient for the registration.ore

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactation women. 2) History of other malignancies within the last 5 years. 3) History of bilateral breast cancer 4) History of serious allergy 5) Serious cardiac disfunction 6) Patients judged by the investigator to be unfit to be enrolled into the study.

Design outcomes

Primary

Measure	Time frame
Feasibility	—

Secondary

Measure	Time frame
Safety Overall survival Disease free survival Relation between Relative Dose Intensity (RDI) of Nab-Paclitaxel and Disease Free Survival ratio	—

Countries

Japan

Contacts

Public ContactToshihiro Kai

Saitama Breast Cancer Clinical Study Group(SBCCSG) Secretariat Division (Shintoshin Ladies' Mammo Clinic)

toshikai@sbccsg.org048-600-1722

Outcome results

None listed

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