Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in HER-2 Positive Breast Cancer

NCT07093931 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: MA-BC-III-HER2+-001
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the efficacy, safety and tolerability of lobaplatin versus carboplatin as neoadjuvant therapy for stage II / III HER-2 positive breast cancer. Arms and Interventions Control group : Docetaxeor albumin paclitaxel combined with carboplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. Experimental group : Docetaxel or albumin paclitaxel combined with lobaplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.

Conditions

Breast Cancer

Keywords

HER-2 positive breast cancer; Pathological Complete Response; Neoadjuvant Therapt; lobaplatin

Outcome Measures

Primary Outcomes (2)

• Pathological Complete Response

  pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive tumor on hematoxylin and eosin evaluation of breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants.

  Up to approximately 27-30 weeks

• Adverse events (AEs)

  AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. In general, AEs are graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE. The type, grade and frequency of AEs will be reported.

  Up to approximately 35 weeks

Secondary Outcomes (4)

• Event-Free Survival (EFS) in all participants

  Up to approximately 5 years

• Objective Overall Response Rate (ORR)

  Up to approximately 25-30 weeks

• Disease-free survival ( DFS )

  Up to approximately 5 years

• Distant Disease-Free Survival(DDFS)

  Up to approximately 5 years

Study Arms (2)

Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab

OTHER

Docetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w ) combined with carboplatin ( AUC 5-6 i.v. q3w ) for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.

Drug: carboplatin; Drug: Docetaxel or albumin paclitaxel; Drug: Trastuzumab; Drug: pertuzumab

Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab

EXPERIMENTAL

Docetaxel ( 75mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260mg / m2 i.v. d1, q3w ) combined with lobaplatin ( 30mg / m2 i.v. q3w ) for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.

Drug: lobaplatin; Drug: Docetaxel or albumin paclitaxel; Drug: Trastuzumab; Drug: pertuzumab

Interventions

lobaplatin DRUG

30mg / m2 i.v. q3w

Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab

carboplatin DRUG

AUC 5-6 i.v. q3w

Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab

Docetaxel or albumin paclitaxel DRUG

Docetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w )

Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab; Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab

Trastuzumab DRUG

6 cycles of treatment, according to the instructions recommended dosage.

Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab; Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab

pertuzumab DRUG

6 cycles of treatment, according to the instructions recommended dosage.

Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab; Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed breast cancer
• Years, female;
• life expectancy is not less than 3 months
• Histologically confirmed HER2 positive ( human epidermal growth factor receptor 2 \[ HER2 \] positive, estrogen receptor \[ ER \] and progesterone receptor \[ PR \] negative or positive );
• Stage at presentation: T1c N1-2 or T2-4 N0-2;
• at least one measurable lesion according to RECIST 1.1;
• Adequate function of major organs meets the following requirements:
• Neutrophils ≥ 1.5×10\^9/L
• Platelets ≥ 100×10\^9/L
• Hemoglobin ≥ 90g/L
• lymphocyte≥0.5×10\^9/L
• Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
• ALT and AST ≤ 3 × ULN
• ALP≤ 2.5 × ULN
• BUN and Cr ≤ 1.5 × ULN

You may not qualify if:

• Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
• Inflammatory breast cancer
• patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
• Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
• Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies .Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
• Major surgical procedure within 4 weeks prior to initiation of study treatment
• Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus
• Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases
• Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study .Has a known history of Human Immunodeficiency Virus (HIV).
• Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis
• Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment
• Has evidence of active tuberculosis within 1year prior to initiation of study treatment
• Prior allogeneic stem cell or solid organ transplantation
• Pre-existing motor or sensory neuropathy of a severity≥grade 2

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead
• Cancer Hospital Chinese Academy of Medical Science: collaborator

Study Sites (1)

Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences

Shandong, Jinan, 250117, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

lobaplatin; Carboplatin; Docetaxel; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yongsheng Wang, MD

CONTACT

+8613505409989; wangysh2008@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)