Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

• Sponsor: Fudan University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05572645
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 3
• Patients Per Site Per Month: 99.3

Study Details

Study Description

Brief Summary

Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Pyrotinib Plus Trastuzumab; Drug: Pertuzumab Plus Trastuzumab

Detailed Description

This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in patients with HER2-positive metastatic breast cancer.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
PyroH treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)	Drug: Pyrotinib Plus Trastuzumab; treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)
PertH treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)	Drug: Pertuzumab Plus Trastuzumab; treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)

Outcome Measures

Primary Outcome Measures

1. PFS [6 weeks]

   Progression free survival

Secondary Outcome Measures

1. Adverse Events [6 weeks]

   Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.

• Patients received Pyrotinib(320-400 mg, po, qd) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or Pertuzumab(840mg q3w, and then 420 mg q3w) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from Jan 2018 to Sep 2022.

• Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.

Exclusion Criteria:

• Incomplete medical history

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biyun Wang, MD, Professor, Fudan University
• ClinicalTrials.gov Identifier: NCT05572645
• Other Study ID Numbers: YOUNGBC-21
• First Posted: Oct 10, 2022
• Last Update Posted: Oct 10, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Biyun Wang, MD, Professor, Fudan University: Pyrotinib; Trastuzumab; Pertuzumab
• Additional relevant MeSH terms: Breast Neoplasms; Trastuzumab; Pertuzumab

Study Results

No Results Posted as of Oct 10, 2022