Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

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: Recruiting

Administrative data

• NCT number: NCT03756064
• Other study ID #: TCHP
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2019
• Source: Zhejiang Cancer Hospital
• Contact: Ding Xiaowen, DR.
• Phone: +86 13588054604
• Email: dingxw[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given 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 (Placebo +Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.

It is proposed that 100 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T1-4N0-3M0) 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: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. female patients, 18 years = age = 80 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 Cancer
• Breast Diseases
• Breast Neoplasms
• Neoplasm, Breast

Intervention

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

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

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