Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer

• Sponsor: Taizhou Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05880927
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

This trial is a multicenter, open-label, phase II trial conducted at 23 centers in China. High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant therapy.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Pyrotinib	Phase 2

Detailed Description

Patients must meet one of the following criteria: N stage ≥1; T stage ≥2; did not achieve pathological complete response (pCR) after neoadjuvant therapy; had pCR after neoadjuvant therapy but with tumor size ≥ 5cm or N stage ≥2; or tumor size less than 2cm but with high Ki67; histologic grade 3 or with lymph node micrometastasis.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pyrotinib 400mg/day High risk HER2 positive patients receive pyrotinib 400mg/day for half or one year	Drug: Pyrotinib; Patients receive pyrotinib 400mg/day for half or one year

Outcome Measures

Primary Outcome Measures

1. iDFS [From date of receiving drug until the date of first documented invasive disease or date of death from any cause, whichever came first, assessed up to 60 months]

   INVASIVE DISEASE FREE SURVIVAL

Secondary Outcome Measures

1. OS [From date of receiving drug until the date of death from any cause, assessed up to 60 months]

   Overall Survival

2. Adverse events [through study completion, an average of 5 years]

   frequency of adverse events

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Women aged 18-75 years old

2. HER2 positive breast cancer

3. ECOG PS 0-1

4. Known hormone receptor status

5. Completed 1 year of trastuzumab-based adjuvant therapy within 6 months

6. Patients at high risk

Exclusion Criteria:

1. Serious heart disease or discomfort

2. Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption

3. Known allergic history of drug components of this regimen

4. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation

5. Pregnant and lactating female patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taizhou Hospital	Taizhou	Zhejiang	China

Sponsors and Collaborators

• Taizhou Hospital

Investigators

• Principal Investigator: Feilin Cao, Master, Taizhou Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haihua Yang, Chief Physician, Taizhou Hospital
• ClinicalTrials.gov Identifier: NCT05880927
• Other Study ID Numbers: PERSIST
• First Posted: May 30, 2023
• Last Update Posted: May 30, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of May 30, 2023