Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in HER-2 Positive Breast Cancer
NCT07093931 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 468
Last updated 2025-07-30
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
Interventions
- DRUG
-
lobaplatin
30mg / m2 i.v. q3w
- DRUG
-
AUC 5-6 i.v. q3w
- DRUG
-
Docetaxel or albumin paclitaxel
Docetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w )
- DRUG
-
6 cycles of treatment, according to the instructions recommended dosage.
- DRUG
-
6 cycles of treatment, according to the instructions recommended dosage.
Sponsors & Collaborators
-
Cancer Hospital Chinese Academy of Medical Science
collaborator UNKNOWN -
Shandong Cancer Hospital and Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2027-08-01
- Completion
- 2030-08-01
Countries
- China
Study Locations
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