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

• Sponsor: Henan Cancer Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03735966
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HER2 Positive Breast Cancer	Drug: Pyrotinib plus trastuzumab and docetaxel and carboplatin	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 20, 2018
• Anticipated Primary Completion Date: Oct 20, 2020
• Anticipated Study Completion Date: Nov 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pyrotinib plus trastuzumab and docetaxel and carboplatin Pyrotinib + trastuzumab + docetaxel+carboplatin	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

Outcome Measures

Primary Outcome Measures

1. Pathological Complete Response (pCR) [through study completion, an average of 1 year]

   Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated

Secondary Outcome Measures

1. EFS [Following surgery until Year 5]

   Event-free survival

2. DFS [Following surgery until Year 5]

   Disease-free Survival

3. DDFS [Following surgery until Year 5]

   Distance Disease-free Survival

4. ORR [Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months]

   Objective Response Rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henan cancer hospital	Zhengzhou	Henan	China

Sponsors and Collaborators

• Henan Cancer Hospital

Investigators

• Principal Investigator: Zhenzhen Liu, Study Principal Investigator Henan Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Henan Cancer Hospital
• ClinicalTrials.gov Identifier: NCT03735966
• Other Study ID Numbers: HR-NeoBC-HN002
• First Posted: Nov 8, 2018
• Last Update Posted: Apr 27, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Carboplatin; Docetaxel; Trastuzumab

Study Results

No Results Posted as of Apr 27, 2020