HER2-positive Breast CancerNCT05561686
Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer
An observational study of HER2-positive Breast Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Pyrotinib
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with HER2-positive breast cancer scheduled to receive pirotinib as neoadjuvant therapy
Who may be able to join
- age ≥ 18 years and ≤ 65 years
- breast cancer meeting the following criteria: Histologically confirmed invasive breast cancer with a primary tumor > 2 cm in diameter as determined by standard assessment at the site
- HER2 expression positive breast cancer confirmed by pathological examination, defined as an immunohistochemical (IHC) score of 3 + in > 10% of immunoreactive cells or HER2 gene amplification by in situ hybridization (ISH) results (HER2 gene signal to centromere 17 signal ratio ≥ 2.0 or HER2 gene copy number ≥ 6).
- known hormone receptor status (ER and PgR);
- The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, and no leukocyte-elevating or platelet-elevating drugs have been used):
- 1) Blood routine neutrophil (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; hemoglobin (Hb) ≥ 90 g/L; 2) Blood biochemistry total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Echocardiography left ventricular ejection fraction (LVEF) ≥ 55%; 4) 12-lead electrocardiogram Fridericia-corrected QT interval (QTcF) < 470 msec.
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- 6. For female patients who are not postmenopausal or surgically sterile: agree to abstain from sexual activity or use an effective method of contraception during treatment and for at least 7 months after the last dose of study treatment.
- 7. Voluntarily join this study, sign the informed consent form, have good compliance and are willing to cooperate with the follow-up.
- 8. have received or plan to receive pyrotinib for neoadjuvant therapy 9. have a traceable medical history during treatment
Who cannot join
- did not sign informed consent
- stage IV (metastatic) breast cancer;
- inflammatory breast cancer;
- previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
- Major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures;
- serious heart disease or discomfort, including but not limited to the following diseases:
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- Confirmed history of heart failure or systolic dysfunction (LVEF < 50%);
- High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher grade atrioventricular block (i.e. Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);
- Angina pectoris requiring antianginal medication; -- Clinically significant valvular heart disease;
- ECG shows transmural myocardial infarction;
- Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
- inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption;
- known to be allergic to the drug components of this protocol: a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- pregnant and lactating women (excluding lactating women who stop breastfeeding), fertile women with positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial and within 7 months after the last dose of study drug;
- patients who are participating in other studies
- Have serious concomitant diseases or other conditions that would interfere with the planned treatment of concomitant diseases, or any other condition that would make the patient inappropriate for this study in the opinion of other investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the actual clinical setting. Given the limited real-world data on pyrotinib, real-world studies focusing on neoadjuvant therapy have not been reported. At present, we hope to collect the data of neoadjuvant therapy for HER2-positive breast cancer patients who have been prescribed pyrotinib, and explore the efficacy and safety of pyrotinib-based neoadjuvant therapy for HER2-positive early or locally advanced breast cancer patients; exploratory analysis to explore the correlation between TMB levels and pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib-based neoadjuvant therapy on intestinal flora.
Read the detailed description
Pyrotinib is a small molecule, irreversible, pan-ErbB receptor tyrosine kinase inhibitor that simultaneously acts on three targets, HER1, HER2, and HER4, and is stable, well tolerated, and easily penetrates the blood-brain barrier compared with macromolecular targeted drugs. In the phase II study of pyrotinib combined with capecitabine in HER2-positive breast cancer, the primary study endpoint ORR was 78.5%, and the investigator-assessed PFS reached 18.1 months with good safety; it was precisely by virtue of the phase II clinical study that the drug was preferentially approved by the State Drug Administration for marketing. During the four years of marketing, significant therapeutic effects have also been achieved in phase III clinical studies, such as the PHOEBE study and the PHENIX study; neoadjuvant treatment of patients with early and locally advanced HER2-positive breast cancer was approved for the PHEDRA study in 2022.
Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the actual clinical setting. Given the limited real-world data on pyrotinib, real-world studies focusing on neoadjuvant therapy have not been reported. At present, we hope to collect the data of neoadjuvant therapy for HER2-positive breast cancer patients who have been prescribed pyrotinib, and explore the efficacy and safety of pyrotinib-based neoadjuvant therapy for HER2-positive early or locally advanced breast cancer patients; exploratory analysis to explore the correlation between TMB levels and pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib-based neoadjuvant therapy on intestinal flora.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Pyrotinib
- Keywords
- RWS, Pyrotinib, Neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
This study adopted a prospective, multicenter, observational design. From October 1, 2022, 100 patients with HER2-positive breast cancer scheduled to receive neoadjuvant therapy with pyrotinib were enrolled. The treatment regimen was determined according to the patient 's condition, physician' s treatment experience, evidence-based evidence and other factors to assess the clinical benefit (pCR, ORR) and safety of different neoadjuvant therapy modalities containing pyrotinib. Exploratory analysis was performed to investigate the correlation between the level of TMB and the pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib on intestinal flora.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib-based combination therapy | Pyrotinib, 400mg po qd, 21 days/cycle Receives: Drug: Pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pathologic complete response（tPCR）
No histological evidence of malignant tumor was found in the primary breast focus and armpit of neoadjuvant patients, or only carcinoma in situ (ypT0/is ypN0).
Measured: Estimated 24 months
Secondary outcomes (3)
breast pathologic complete response(bPCR)
No histological evidence of malignant tumor was found in the primary breast lesions of neoadjuvant patients, or only carcinoma in situ (ypt0 /is).
Measured: Estimated 24 months
Objective Response Rate (ORR)
Ratio of CR and PR in all subjects
Measured: Estimated 24 months
Adverse Events and Serious Adverse Events
Adverse events are described in terms of CTC AE 5.0
Measured: From informed consent through 28 days following treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ying He, M.D., Study chair, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561686
- Sponsor's protocol ID
- HunanCH-BC-001
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT05561686
- Acronym / sponsor ID
- HunanCH-BC-001
- Conditions
- HER2-positive Breast Cancer
- Keywords
- RWS, Pyrotinib, Neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the actual clinical setting. Given the limited real-world data on pyrotinib, real-world studies focusing on neoadjuvant therapy have not been reported. At present, we hope to collect the data of neoadjuvant therapy for HER2-positive breast cancer patients who have been prescribed pyrotinib, and explore the efficacy and safety of pyrotinib-based neoadjuvant therapy for HER2-positive early or locally advanced breast cancer patients; exploratory analysis to explore the correlation between TMB levels and pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib-based neoadjuvant therapy on intestinal flora.
Detailed description
Pyrotinib is a small molecule, irreversible, pan-ErbB receptor tyrosine kinase inhibitor that simultaneously acts on three targets, HER1, HER2, and HER4, and is stable, well tolerated, and easily penetrates the blood-brain barrier compared with macromolecular targeted drugs. In the phase II study of pyrotinib combined with capecitabine in HER2-positive breast cancer, the primary study endpoint ORR was 78.5%, and the investigator-assessed PFS reached 18.1 months with good safety; it was precisely by virtue of the phase II clinical study that the drug was preferentially approved by the State Drug Administration for marketing. During the four years of marketing, significant therapeutic effects have also been achieved in phase III clinical studies, such as the PHOEBE study and the PHENIX study; neoadjuvant treatment of patients with early and locally advanced HER2-positive breast cancer was approved for the PHEDRA study in 2022.
Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the actual clinical setting. Given the limited real-world data on pyrotinib, real-world studies focusing on neoadjuvant therapy have not been reported. At present, we hope to collect the data of neoadjuvant therapy for HER2-positive breast cancer patients who have been prescribed pyrotinib, and explore the efficacy and safety of pyrotinib-based neoadjuvant therapy for HER2-positive early or locally advanced breast cancer patients; exploratory analysis to explore the correlation between TMB levels and pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib-based neoadjuvant therapy on intestinal flora.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib-based combination therapy | – | Drug: PyrotinibPyrotinib, 400mg po qd, 21 days/cycle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HER2-positive breast cancer scheduled to receive pirotinib as neoadjuvant therapy
Key inclusion criteria (9 listed)
- age ≥ 18 years and ≤ 65 years
- breast cancer meeting the following criteria: Histologically confirmed invasive breast cancer with a primary tumor > 2 cm in diameter as determined by standard assessment at the site
- HER2 expression positive breast cancer confirmed by pathological examination, defined as an immunohistochemical (IHC) score of 3 + in > 10% of immunoreactive cells or HER2 gene amplification by in situ hybridization (ISH) results (HER2 gene signal to centromere 17 signal ratio ≥ 2.0 or HER2 gene copy number ≥ 6).
- known hormone receptor status (ER and PgR);
- The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, and no leukocyte-elevating or platelet-elevating drugs have been used):
Key exclusion criteria (16 listed)
- did not sign informed consent
- stage IV (metastatic) breast cancer;
- inflammatory breast cancer;
- previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
- Major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyrotinibThis study adopted a prospective, multicenter, observational design. From October 1, 2022, 100 patients with HER2-positive breast cancer scheduled to receive neoadjuvant therapy with pyrotinib were enrolled. The treatment regimen was determined according to the patient 's condition, physician' s treatment experience, evidence-based evidence and other factors to assess the clinical benefit (pCR, ORR) and safety of different neoadjuvant therapy modalities containing pyrotinib. Exploratory analysis was performed to investigate the correlation between the level of TMB and the pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib on intestinal flora. | Drug | Pyrotinib-based combination therapy |
Primary outcome
Total pathologic complete response（tPCR）
Time frame: Estimated 24 months
No histological evidence of malignant tumor was found in the primary breast focus and armpit of neoadjuvant patients, or only carcinoma in situ (ypT0/is ypN0).
3 secondary outcomes
breast pathologic complete response(bPCR)
Time frame: Estimated 24 months
Objective Response Rate (ORR)
Time frame: Estimated 24 months
Adverse Events and Serious Adverse Events
Time frame: From informed consent through 28 days following treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying He, M.D. study chair
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer, run by Hunan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying He, M.D. (0731-89762050, heying@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathologic complete response（tPCR） (time frame: Estimated 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.