Pase II study of neoadjuvant chemotherapy with Docetaxel, Carboplatin, and Trastuzumab for operable Her2-positive breast cancer patients.

Pase II study of neoadjuvant chemotherapy with Docetaxel, Carboplatin, and Trastuzumab for operable Her2-positive breast cancer patients. - KBC-SG 1201

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000012256

Enrollment

Registered

2013-11-09

Start date

2013-06-01

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

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with histological confirmed invasive breast cancer at diagnosis. 2. Operable breast cancer. TMN:T1b-T3, N0-N2, M0 3. Her2(3+) by core needle biopsy before treatment and/or FISH(+)before registration. 4. At least one measurable region (RECIST version1.1). 5. No prior treatment for breast cancer. 6. PS:0-1 7. Adequate main organ function. 4000/mm3<=WBC <12000 and/or 2000/mm3<=neutorophil PLT>=100000/mm3 AST, ALT<=ULN*2.5 T.Bil<=1.5mg/dl Cr<=1.5mg/dl Normal electrocardiogram. LVEF: 55%<= 8. Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Clinically inadequate heart function at the registration and/or with past history. 2.Severe uncontrolled complications (Uncontrolled DM, HT, liver dysfunction, renal dysfunction, infection mental manifestation). 3.Women during pregnancy or shortly after childbirth. 4.Double active cancer (in less than 5 years after the last treatment). 5.Women with bilateral breast cancer (synchronous or heterochronous). 6.Women with pulmonary fibrosis and/or interstitial pneumonia. 7.Patients with allergy to the medicines in this protocol treatment. 8.Patients judged inappropriate for this study by the physicians.

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate.	—

Countries

Japan

Contacts

Public ContactKazuo Tamura

Kyushu Breast Cancer Study Group Organizer

kbc@chotsg.com092-801-2845

Outcome results