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

HER2-positive Breast Cancer Clinical Trial

Official title:

A Prospective, Open-label,Multicenter Phase II Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Chemotherapy in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03847818
• Other study ID #: 495573096
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2019
• Source: Shandong University
• Contact: Yu Zhigang, DR.
• Phone: +86 13864182636
• Email: yzg[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Description:

The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.

It is proposed that 268 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T2-3N0-3M0) who are eligible for primary systemic therapy.

The primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 268
• Est. completion date: February 28, 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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)

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

5. Known hormone receptor status.

6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)=55% measured by ECHO

7. Signed informed consent form (ICF)

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+Trastuzumab+Docetaxel+Carboplatin
Drug: Pyrotinib Pyrotinib: 400mg orally daily Drug: Trastuzumab Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles; Drug: Docetaxel Docetaxel: 75mg/m2 for a total of 6 cycles Drug: Carboplatin Carboplatin: AUC=5 or 6 for a total of 6 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Pathological Complete Response (pCR)		through study completion, an average of 1 year
Secondary	Event-free survival		Following surgery until Year 3
Secondary	Disease-free Survival		Following surgery until Year 3
Secondary	Distance Disease-free Survival		Following surgery until Year 3
Secondary	Objective Response Rate		Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery) up to approximately 12 months