Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients.

HER2 Positive Breast Cancer Clinical Trial

Official title:

Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer : a Single-arm,Ahead , Open-label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03735966
• Other study ID #: HR-NeoBC-HN002
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2018
• Est. completion date: October 20, 2020

Study information

• Verified date: April 2020
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Description:

Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. In recent years, the anti-HER2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Based on previous clinical studies, we designed the study to explore the possibility of Pyrotinib in combination with Trastuzumab plus Docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. female patients, 18 years = age = 75 years.

2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.

3. Histologically confirmed invasive breast cancer(early stage or locally advanced):Primary tumour greater than 2 cm diameter

4. HER2 positive (HER2+++ by IHC or FISH+)

5. Life expectancy of more than 3 months

6. Known hormone receptor status.

7. Required laboratory values including following parameters: ANC: = 1.5 x 10^9/L;Platelet count: = 100 x 10^9/L;Hemoglobin: = 9.0 g/dL;Total bilirubin: = 1.5 x upper limit of normal (ULN);ALT and AST: = 1.5 x ULN (or = 5×ULN in patients with liver metastases);BUN and creatine clearance rate: = 50 mL/min;LVEF: = 50%;QTcF: < 470 ms for female and < 450 ms for male.

8. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

1. metastatic disease (Stage IV) or inflammatory breast cancer.

2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.

3. clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension =180/110);

4. Unable or unwilling to swallow tablets.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2 Positive Breast Cancer

Intervention

Drug:
• Pyrotinib plus trastuzumab and docetaxel and carboplatin
pyrotinib: 320mg orally daily,6cycles; trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6cycles; docetaxel:after the biological window, 100mg/m2 for a total of 6 cycles carboplatin:d1 ,AUC 6 iv 3-weekly for a total of 6 cycles

Locations

Country	Name	City	State
China	Henan cancer hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response (pCR)	Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated	through study completion, an average of 1 year
Secondary	EFS	Event-free survival	Following surgery until Year 5
Secondary	DFS	Disease-free Survival	Following surgery until Year 5
Secondary	DDFS	Distance Disease-free Survival	Following surgery until Year 5
Secondary	ORR	Objective Response Rate	Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months