Re-treatment of pyrotinib in HER2-positive recurrent or metastatic breast cancer: a retrospective study
| ISRCTN | ISRCTN93654271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93654271 |
- Submission date
- 25/03/2024
- Registration date
- 03/04/2024
- Last edited
- 02/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Breast cancer is the most common cancer in women globally, representing 11.7% of cases and a leading cause of cancer-related deaths (15.5%). It's classified into four types: luminal A, luminal B, HER-2-positive, and triple-negative. HER-2-positive breast cancer, comprising 15-20% of cases, is aggressive but treatable with targeted therapies like monoclonal antibodies and tyrosine kinase inhibitors (TKIs), offering advantages such as oral administration and reduced side effects. Pyrotinib, a Chinese-developed TKI, targets HER-2-positive breast cancer by blocking growth signals, proving effective, especially against brain metastases.
Resistance to treatment is a challenge, but recent evidence suggests potential effectiveness of re-treatment after a break. Investigating pyrotinib re-treatment in recurrent or metastatic HER2-positive breast cancer provides new treatment options, potentially improving survival and quality of life.
To assess this, researchers aim to collect real-world data on patient demographics, treatment history, pyrotinib dosing, supportive care, and clinical outcomes such as progression-free and overall survival. Understanding the safety profile of pyrotinib-based therapy is crucial for ensuring its safe use.
Who can participate?
Patients eligible for inclusion in the study are between the ages of 18 and 80 and have been diagnosed with recurrent or metastatic breast cancer confirmed as HER2-positive through pathology testing, with HER2 positivity defined by specific immunohistochemistry and in-situ hybridization criteria. Additionally, eligible patients must have undergone at least two lines of treatment containing pyrotinib for advanced disease and have a follow-up period of at least 2 months from the initiation of the pyrotinib-containing regimen. They must also exhibit a measurable lesion according to established criteria and possess adequate hematologic, hepatic, and renal functions.
What does the study involve?
The study is planned to include patients with HER2-positive recurrent or metastatic breast cancer. All patients included in the analysis have previously received a pyrotinib-containing regimen, with no restriction on the specific dosing regimen, and are fully guided by the physician's clinical choice, to assess the efficacy as well as the safety of re-treatment with a pyrotinib-containing regimen.
What are the possible benefits and risks of participating?
This is a retrospective study and patients may potentially benefit from the new treatment strategy of retreatment with pyrotinib.
In this study, pyrotinib treatment may trigger drug-related side effects, most commonly diarrhea. In addition to diarrhea, other possible side effects include neutropenia and anemia.
Where is the study run from?
The Second Xiangya Hospital of Central South University (China)
When is the study starting and how long is it expected to run for?
September 2023 to February 2025.
Who is funding the study?
This study was funded by the Innovation Platform and Talent Plan of Hunan Province (Grant No.2023SK4019), the Science and Technology Innovation Program of Hunan Province (Grant No. 2021SK2026), the Clinical Medical Boot Technology Innovation Project of Hunan Province (Grant No. 2021SK53504), the Health and Family Planning Commission of Hunan Province (Grant No. 2022JJ70143), and the Clinical Research Special Fund of Wu Jieping Medical Foundation (Grant No. 320.6750.2022-19-29) (China)
Who is the main contact?
Wenjun Yi, Director of Breast Surgery Department at Xiangya Second Hospital of Central South University. Email: yiwenjun@csu.edu.cn.
Contact information
Principal Investigator
No. 139, Renmin Central Road
Changsha
410011
China
 ORCID ID |
0000-0003-0699-7932 |
|---|---|
| Phone | +86 13507483318 |
| yiwenjun@csu.edu.cn |
Public, Scientific
No. 139, Renmin Central Road
Changsha
410011
China
| Phone | +86 15802590050 |
|---|---|
| jingpeng@csu.edu.cn |
Study information
| Study design | Real-world multicenter retrospective cohort observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Medical and other records, Telephone |
| Study type | Quality of life, Treatment, Safety, Efficacy |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Efficacy of re-treatment of pyrotinib in HER2-positive recurrent or metastatic breast cancer |
| Study hypothesis | Re-treatment with pyrotinib is effective in patients with HER2-positive recurrent or metastatic breast cancer. |
| Ethics approval(s) |
Approved 28/02/2024, Clinical Research Ethics Committee, The Second Xiangya Hospital, Central South University, China (No. 139, Renmin Middle Road, Furong District, Changsha, 410011, China; +86 731-85292476; xyf2gcp@126.com), ref: LYF20230190 |
| Condition | Treatment for HER2-positive recurrent or metastatic breast cancer |
| Intervention | All patients included in the analysis have previously received a pyrotinib-containing regimen, with no restriction on the specific dosing regimen, and are fully guided by the physician's clinical choice, to assess the efficacy as well as the safety of re-treatment with a pyrotinib-containing regimen. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Bioequivalence |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Pyrotinib Maleate Tablets |
| Primary outcome measure | Progression-free survival (PFS) on the first pyrotinib treatment and PFS on re-treatment with pyrotinib) measured using patient records |
| Secondary outcome measures | Measured using patient records: 1. OS (overall survival) 2. ORR (objective response rate assessed by RECIST 1.1) 3. CBR (clinical benefit rate assessed by RECIST 1.1) |
| Overall study start date | 01/09/2023 |
| Overall study end date | 27/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 360 |
| Participant inclusion criteria | 1. Patients aged ≥18 years and <80 years. 2. Patients diagnosed with recurrent or metastatic breast cancer as HER2-positive by pathology testing (HER2-positive is defined as an immunohistochemistry (IHC) score of 3+ or 2+ for HER2 and a positive in-situ hybridization (ISH) test confirmed by a pathology laboratory). 3. Have received at least two lines of pyrotinib-containing regimens in advanced stages. 4. Have at least 2 months or more of follow-up data from the initiation of the pyrotinib-containing regimen to the point of data collection. 5. Presence of a measurable lesion as defined by the revised Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). 6. Adequate hematologic, hepatic, and renal functions. |
| Participant exclusion criteria | 1. Pyrotinib medication use as neoadjuvant therapy. 2. Severe adverse side effects could not be controlled by dose reductions according to drug instructions. 3. Loss to follow-up for other unknown reasons. |
| Recruitment start date | 01/09/2023 |
| Recruitment end date | 31/12/2023 |
Locations
Countries of recruitment
- China
Study participating centres
Changsha
410011
China
Changde
415000
China
Changde
415000
China
Changde
415000
China
Chenzhou
423001
China
Ganzhou
341000
China
Ganzhou
341000
China
Changsha
410007
China
Changsha
410005
China
Changsha
410013
China
Huaihua
410000
China
Yiyang
410008
China
Changsha
410007
China
Huaihua
418200
China
Huaihua
418099
China
Nanchang
330029
China
Loudi
417000
China
Nanchang
330006
China
Nanchang
330009
China
Hengyang
421001
China
Hengyang
421002
China
Shaoyang
422000
China
Shaoyang
422001
China
Xiangtan
411100
China
Xiangtan
411100
China
Xiangtan
411104
China
Xiangtan
411100
China
Xiangxi
416000
China
Changde
415000
China
Yichun
336000
China
Yiyang
413000
China
Yongzhou
425000
China
Yongzhou
425000
China
Yongzhou
425000
China
Yugan
335100
China
Yueyang
414000
China
Yueyang
414000
China
Yueyang
414000
China
Changsha
410205
China
Changsha
410006
China
Changsha
410004
China
Changsha
410003
China
Changsha
410008
China
Zhuzhou
412007
China
Sponsor information
Hospital/treatment centre
No. 139, Renmin Central Road
Changsha
410011
China
| Phone | +86 731-85533525 |
|---|---|
| kyb4080@163.com | |
| Website | https://www.xyeyy.com/3042/3044/index.htm |
Funders
Funder type
Government
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
02/04/2024: Trial's existence confirmed by Clinical Research Ethics Committee, The Second Xiangya Hospital, Central South University, China.
