Ki67 index guided selection of preoperative chemotherapy for HER2 positive breast cancer - a randomized phase 2 trial

Ki67 index guided selection of preoperative chemotherapy for HER2 positive breast cancer - a randomized phase 2 trial - Ki67 index guided selection of preoperative chemotherapy - a randomized phase 2 trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007074

Enrollment

200

Registered

2012-01-20

Start date

2011-11-01

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

HER2 positive breast cancer

Interventions

Ki-67 based treatment arm: Ki67 is evaluated after the first course of preoperative chemotherapy with trastuzumab and paclitaxel. When the enough reduction in Ki67 is achieved, same regimen is conti

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Histologically proven breast cancer (invasive ductal carcinoma) (2) Stage2 or 3 (3) Women aged 20 to 75 years old (4) HER2 positive breast cancer (IHC3+ or FISH+) (5) LVEF is 55% and more (6) Performance status (PS):0-1 (Eastern Cooperative Oncology Group ; ECOG) (7) Sufficient organ functions (8) No prior endocrine therapy or chemotherapy for breast cancer (9) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Simultaneous double cancers (2) Metachronous or bilateral breast cancer (3) Hypersensitivity to the drugs used in this study (4) Prior or concurrent cardiac disease, such as congestive heart failure, myocardial infarction, ischemic heart disease, arrhythmia, valvular heart disease (5) Uncontorolled hypertension (6) Uncontorolled diabetes mellitus (7) Inappropriate by the physician's judgment

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate	—

Secondary

Measure	Time frame
Objective response rate Disease-free survival Overall survival	—

Countries

Japan

Contacts

Public ContactTakeshi Yamaguchi

National Cancer Center Hospital East Department of Hematology and Oncology

Outcome results

None listed

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