Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer

Breast Cancer Clinical Trial

Official title:

Neoadjuvant Treatment of Pyrotinib in Combination With Trastuzumab and Abraxane in Patients With HER2-enriched Early or Locally Advanced Breast Cancer, a Single, One Arm, Multicenter II Phase Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659056
• Other study ID #: NJMU-BC01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 29, 2022
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Wenbin Zhou, Professor
• Phone: 025-68308162
• Email: Zhouwenbin[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• 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)

4. HER2 positive (HER2+++ by IHC or FISH+), and the HER2-enriched subtype screened by BulePrint test;

5. Primary breast cancer;

6. Known hormone receptor status.

7. The organs are functioning normally, like the liver function, the renal function, and the baseline left ventricular ejection fraction (LVEF)=55% measured by ECHO

8. 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. A history of allergy to the drugs in this study;

5. Unable or unwilling to swallow tablets

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pyrotinib, trastuzumab, paclitaxel-albumin
pyrotinib: 400mg orally daily; trastuzumab: 8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles; paclitaxel-albumin: 260mg/m2, every 3 week, a total of 6 cycles

Locations

Country	Name	City	State
China	JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators	pCR	Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 4 weeks after Cycle 6, each cycle is 21 days)
Secondary	Event-free survival	EFS	Following surgery until year 2
Secondary	Objective Response Rate	ORR	Baseline up to cycle 6 (assessed at Baseline, at the time of pre-surgery), up to approximately 5 months after neoadjuvant (each cycle is 21 days)
Secondary	minimal residual lesions	MRD	Following surgery until year 2