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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorShandong Cancer Hospital and Institute

About this trial

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.

Eligibility criteria

Qualifiers

Newly diagnosed breast cancer

18-70 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 );

Disqualifiers

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

Trial design

Treatments tested in this trial

  • lobaplatin
  • carboplatin
  • Docetaxel or albumin paclitaxel
  • Trastuzumab
  • pertuzumab

Treatment groups

468 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shandong Cancer Hospital and Institute

Lead sponsor

Cancer Hospital Chinese Academy of Medical Science

Collaborator