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A prospective randomized controlled trial for neoadjuvant chemotherapy with docetaxel, lobaplatin plus trastuzumab (TLH) for HER2-positive breast cancer

A prospective randomized controlled trial for neoadjuvant chemotherapy with docetaxel, lobaplatin plus trastuzumab (TLH) for HER2-positive breast cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020175
Enrollment
Unknown
Registered
2018-12-19
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Group 1:neoadjuvant docetaxel,lobaplatin and trastuzumab
Group 2:neoadjuvant docetaxel,carboplatin and trastuzumab

Sponsors

First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 65 years old; 2) Stage I to III breast cancer before surgery. Diagnosed by pathological examination with hollow needle biopsy before therapy started and resectable. IHC method examination showed: ER(-), PR(-), HER-2/neu(+); 3) The size of the cancer is measurable; 4) With no distant metastasis according to abdominal ultrasound and breast X-ray and whole body bone scan and fine needle aspiration to local lymph node enlargement. With no other malignancy; 5) Capable to follow the scheme; 6) ECOG score as 0 or 1; 7) Willing to join in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Being pregnant or breasting-feeding; 2) With serve complication of heart, liver, kidney or endocrine system and with expected survival period less than 2 year; 3) Allergic to the drugs involved in the study; 4) Karnofsky score less than 60; 5) Unable to accept investigation on time; 6) Not suitable for the trial because of other reasons according to the researchers.

Design outcomes

Primary

MeasureTime frame
pCR (pathologic complete response);overall survival;disease-free survival;

Secondary

MeasureTime frame
Conmon terminology criteria adverseevents;CR (complete response);PR (partial response);SD (stable disease);PR (progressive disease);

Countries

China

Contacts

Public ContactYi Zhang

First Affiliated Hospital of Army Medical University

zy53810@163.com+86 13983701489

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026