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

Browse trials for

• Breast Neoplasms 12,544

Keywords

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

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 468 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Shandong Cancer Hospital and Institute is the lead sponsor of 103 studies on the registry; 36 are open to participants now.

Study arms

• Other
  Docetaxel or albumin paclitaxel+carboplatin+Trastuzumab+pertuzumab

  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

• Experimental
  Docetaxel or albumin paclitaxel+lobaplatin +Trastuzumab+pertuzumab

  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

• Druglobaplatin

  30mg / m2 i.v. q3w

• Drugcarboplatin

  AUC 5-6 i.v. q3w

• DrugDocetaxel or albumin paclitaxel

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

• DrugTrastuzumab

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

• Drugpertuzumab

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

Primary outcomes

1. 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.

   Time frame: Up to approximately 27-30 weeks

2. 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.

   Time frame: Up to approximately 35 weeks

Secondary outcomes

1. Event-Free Survival (EFS) in all participants

   EFS is defined as the time from start of study treatment to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.

   Time frame: Up to approximately 5 years

2. Objective Overall Response Rate (ORR)

   ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until definitive surgery or disease progression.

   Time frame: Up to approximately 25-30 weeks

3. Disease-free survival ( DFS )

   DFS is defined as the time interval from the first day of disease-free ( i.e., the date of surgery ) to the first recording of related events, including postoperative disease recurrence and metastasis and death from any cause.

   Time frame: Up to approximately 5 years

4. Distant Disease-Free Survival(DDFS)

   DDFS is defined as the time interval from the beginning of treatment ( such as surgery, radiotherapy or drug intervention ) to the first occurrence of distant metastasis or death from any cause.

   Time frame: Up to approximately 5 years

Individual participant data

Plan to share: Yes