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Pyrotinib Combined With Capecitabine in HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05359120
Recruitment Status : Recruiting
First Posted : May 3, 2022
Last Update Posted : September 19, 2022
Sponsor:
Information provided by (Responsible Party):
Henan Cancer Hospital

Brief Summary:
This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive advanced breast cancer with brain metastases.

Condition or disease
Breast Cancer

Detailed Description:

This study is a multicenter, observational, real-world study with no formal statistical assumptions and sample size calculations; patient efficacy and safety data will be descriptively analyzed to assess the risk of HER2-positive advanced breast cancer patients with brain metastases. Efficacy of pyrotinib combined with capecitabine regimen in the real world, while evaluating the overall survival benefit of local therapy and drug therapy in patients with brain metastases.

The estimated sample size is 300 cases, and at least one group of cohort A, cohort B and cohort C is planned to exceed 100 cases; Cohort A - patients with new brain metastases directly treated with pyrotinib combined with capecitabine; Cohort B- Whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine; Cohort C - group of patients with pyrotinib plus capecitabine after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy)。

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Nationwide Multicenter, Ambispective Real-world Study of Pyrotinib Combined With Capecitabine in Patients With HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)
Actual Study Start Date : May 30, 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
cohort A
new brain metastases directly treated with pyrotinib combined with capecitabine
cohort B
whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine
cohort C
after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy) treated with pyrotinib combined with capecitabine



Primary Outcome Measures :
  1. Time to Failure(TTF) [ Time Frame: up to 2 years ]
    Time from initiation of study protocol treatment to treatment failure or study protocol discontinuation for any reason (including discontinuation due to patient request, disease progression, adverse events, or death)


Secondary Outcome Measures :
  1. Progression-free survival(PFS) [ Time Frame: up to 2 years ]
    Time from initiation of study protocol treatment to disease progression (if occurring within 30 days of end of treatment) or death, as assessed by clinician or with or without radiographic progression.

  2. CNS-DCR [ Time Frame: up to 2 years ]
    The patients began to receive the treatment plan of this study, and during the period of the patients' disease progression group, the number of patients with the best response effect of intracranial lesions in the patient's medical records were objective remission (CR+PR) and stable disease (SD) in the analysis data set. The sum of the percentages of the total population.

  3. CNS-CBR [ Time Frame: up to 2 years ]
    The patient started to receive the treatment plan of this study, and during the period of the patient's disease progression group, the best response effect of intracranial lesions in the patient's medical records was complete remission (CR) + partial remission (PR) + stable disease (SD) ≥ 6 The sum of the month's patient population as a percentage of the total population in the analyzed dataset.

  4. CNS-ORR [ Time Frame: up to 2 years ]
    Among all patients who received pyrotinib plus capecitabine for brain metastases, the proportion of patients with physician-assessed complete remission (CR) or any less than complete remission (documented remission) in the patient's medical records on radiology scans.

  5. CNS-DOR [ Time Frame: up to 2 years ]
    Duration between first scan showing documented remission of intracranial lesions and first scan showing disease progression or end of treatment if no progression occurred. rwDOR was evaluable in patients who received ≥2 consecutive radiology scans.

  6. Overall Survival(OS) [ Time Frame: up to 2 years ]
    The time from the start of treatment with this study protocol to the time of all-cause death of patients.

  7. safety [ Time Frame: up to 2 years ]
    Refers to the proportion of patients with a clinically significant adverse event (AE) (ie, leading to treatment modification or discontinuation, patient hospitalization, death, or permanent sequelae) documented in the medical records.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cases of patients with brain metastases from HER2-positive advanced breast cancer who received pyrotinib combined with capecitabine from July 2018 to December 2022.
Criteria

Inclusion Criteria:

  1. Pathologically diagnosed patients with HER-2 expression-positive advanced breast cancer; Note: Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization [FISH] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive;
  2. Brain metastases are diagnosed by MRI/enhanced CT imaging, according to RECIST 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases;
  3. Pyrotinib combined with capecitabine in the treatment of brain metastases with non-PD evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments
  4. For previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more;
  5. There are traceable medical history data.

Exclusion Criteria:

  1. Patients enrolled in the previous PERMEATE study;
  2. The research program is receiving other anti-tumor drug treatment at the same time;
  3. The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose;
  4. Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;
  5. The investigator believes that the patient is not suitable to enter this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05359120


Contacts
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Contact: Min Yan 15713857388 ym200678@126.com

Locations
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China, Henan
Henan cancer hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Min Yan, Dr    8615713857388    ym200678@126.com   
Sponsors and Collaborators
Henan Cancer Hospital
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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT05359120    
Other Study ID Numbers: HNCH-MBC09-BM03
First Posted: May 3, 2022    Key Record Dates
Last Update Posted: September 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after de-identification are available following article publication
Supporting Materials: Study Protocol
Time Frame: Three years from publication
Access Criteria: Please contact Central contact person by Email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henan Cancer Hospital:
HER-2 positive advanced breast cancer
pyrotinib
capecitabine
Additional relevant MeSH terms:
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Breast Neoplasms
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases