Prospective study of neoadjuvant chemotherapy for HER2 positive breast cancer.

Prospective study of neoadjuvant chemotherapy for HER2 positive breast cancer. - Prospective study of neoadjuvant chemotherapy for HER2 positive breast cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046338

Enrollment

Registered

2021-12-10

Start date

2019-04-11

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) HER2 positive breast cancer patients diagnosed pathologically (IHC HER2 3+ or HER2 2+/FISH positive). 2) Patients indicated to neoadjuvant chemotherapy. 3) Patients must have Eastern Cooperative Oncology group (ECOG) Performance Status 0 or 1.

Exclusion criteria

Exclusion criteria: 1) Patients with active other cancers required to treat. 2) Patients with heart function failure (EF<60%). 3) Patients determined as being an inappropriate case by the investigators.

Design outcomes

Primary

Measure	Time frame
pCR rate (defined as (ypT0/is and ypN0)	—

Secondary

Measure	Time frame
Tumor reduction rate of docetaxel + T-mab + P-mab, tumor reduction rate of docetaxel + T-mab + P-mab followed by anthracyclin based regimen. DFS, safety, cardiotoxicity, and DFS of patients received only docetaxel + T-mab + P-mab.	—

Countries

Japan

Contacts

Public ContactHiroaki Shima

Sapporo Medical University Surgery, Surgical Oncology and Science

simahiro@sapmed.ac.jp011-611-2111

Outcome results