Skip to content

Neoadjuvant Carboplatin, Eribulin, Trastuzumab and Pertuzumab for Early or locally advanced HER2 Positive Breast Cancer: A prospective, single arm clinical study

Neoadjuvant Carboplatin, Eribulin, Trastuzumab and Pertuzumab for Early or locally advanced HER2 Positive Breast Cancer: A prospective, single arm clinical study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095130
Enrollment
Unknown
Registered
2025-01-02
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-01-06

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:Eribulin mesylate, 1.4 mg /m2, day 1 and day 8
Carboplatin, AUC6, day 1
Trastuzumab, 8 mg/kg load dose in the first cycle and 6 mg/kg in each subsequent cycle on day 1
Pertuzumab, 840 mg load dose in the first cycle and 420 mg in each subsequent cycle on day 1
21 days per cycle, a total of 6 cycles

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Newly treated female patients >=18 years old and =1.5×10^9/L; Platelet count (PLT) >=100×10^9/L; Red blood Protein (Hb) =90 g/L; Blood biochemistry: total bilirubin (TBIL) =55%; For female patients who are not menopausal or have not been surgically sterilized: arrive after the last dose during treatment and study therapy within six months, agree to abstain from sex or use an effective contraceptive method. Participate in this study voluntarily, sign informed consent, have good compliance and willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: Stage IV breast cancer; Other specific types of breast cancer; Antitumor therapy or radiation therapy for any malignancy within the previous 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma; Also receiving antitumor therapy in other clinical trials; Had major non-breast cancer related surgery within 4 weeks prior to randomization, or had not yet undergone such surgery Complete recovery in progress. Serious cardiovascular and cerebrovascular diseases or discomfort, including but not limited to the following diseases: History of heart failure or systolic dysfunction (LVEF 180 mmHg and/or diastolic blood pressure > 100 mmHg) Known allergic history of drug components of the program; A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency conditions, or have a history of organ transplantation; Pregnant and lactating women, fertile women with a positive baseline pregnancy test, or patients in Patients of childbearing age who were unwilling to use effective contraception throughout the trial period; The patient has a serious concomitant disease or other comorbiditis that would interfere with planned treatment, or any other circumstances where the researcher deems the patient unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
pCR rate;

Secondary

MeasureTime frame
Objective Response Rate;Quality of Life;

Countries

China

Contacts

Public ContactJunjie Li

Sichuan Cancer Hospital

504872558@qq.com+86 182 0288 2508

Outcome results

None listed

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