Efficacy and cardiac safety in the neoadjuvant treatment of stage II-III HER2- positive breast cancer with Docetaxel, Carboplatin, Pertuzumab and HLX02: a single-arm study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100041951

Enrollment

Unknown

Registered

2021-01-10

Start date

2021-01-10

Completion date

Unknown

Last updated

2021-03-30

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

Conditions

Breast Cancer

Interventions

Experimental group:TCbHP

Eligibility

Sex/Gender

Female

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with stage II – III HER2 positive breast cancer, t > 2cm; (Note: follow the 2018 asco-cap HER2 positive criteria); 2. Subjects who have not received treatment in the past; 3. Female subjects, aged 18 = 75 years; 4. ECoG 0 or 1; 5. Subjects with baseline left ventricular ejection fraction (LVEF) >= 55%.

Exclusion criteria

Exclusion criteria: 1. Patients with any history of invasive breast cancer (ipsilateral and / or contralateral); 2. Patients with metastatic breast cancer; 3. Patients with other malignant tumor history; 4. Subjects with severe heart or cardiovascular disease or condition, severe renal insufficiency; 5. Other subjects with severe diseases that may interfere with the planned treatment, including severe lung diseases; 6. Pregnant or lactating women; 7. Subjects allergic to any study drug or any ingredient or excipient of these drugs.

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate (pCR);	—

Secondary

Measure	Time frame
cardiac safety;IDFS;	—

Countries

China

Contacts

Public ContactQianjun Chen/ Xiaoyan Liu

Guangdong Hospital of traditional Chinese Medicine

13660796179@163.com+86 18688883505/ +86 13660796179

Outcome results

None listed

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