Phase 2 study of dose dense AC and dose dense PTX as perioperative chemotherapy for patients with HER2 negative breast cancer(WJOG9016B)

Phase 2 study of dose dense AC and dose dense PTX as perioperative chemotherapy for patients with HER2 negative breast cancer(WJOG9016B) - Phase 2 study of dose dense AC and dose dense PTX as perioperative chemotherapy for patients with HER2 negative breast cancer(WJOG9016B)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024992

Enrollment

Registered

2016-11-25

Start date

2017-01-10

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

HER2 negative breast cancer

Interventions

ddAC day1 Doxorubicine 60mg/m2, and Cyclophosphamide 600 mg/m2 day 2, 3, or 4 pegfilgrastim 3.6mg every two weeks, repeat four times ddPTX day1 paclitaxel 175mg/m2, day 2, 3, or 4 pegfilgrastim 3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Invasive ductal carcinoma 2) HER2 negative 3) Stage I-III 4) ECOG PS 0 or 1

Exclusion criteria

Exclusion criteria: 1) Active double cancer 2) Active infection 3) Lactating, pregnant, or not willing to contraception women 4) Mental disorders 5) On steroids or immune suppressants 6) History of severe hypersensitivity 7) History of severe complication 8) Judged as inappropriate to be included study by treating physician

Design outcomes

Primary

Measure	Time frame
The proportion of high RDI, defined as the proportion of patients whose RDI of the therapy exceeds 85 % among those who started treatment	—

Secondary

Measure	Time frame
1) Mean and median RDI of the whole therapy 2) Mean, median and the proportion of high RDI of ddAC 3) Mean, median and the proportion of high RDI of ddPTX 4) The proportion of patients without delay & dose reduction 5) Safety (including SAE) 6) ORR, BCR, pCR, and recurrence of the neoadjuvant treatment 7) Recurrence rate of the adjuvant treatment	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

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