HER2+ Breast CancerNCT06537674
Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer
An observational study of HER2+ Breast Cancer, run by Jiangsu Famous Medical Technology Co., Ltd..
Trial summary
This study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of HER2-positive early breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2+ Breast Cancer
- What is being tested?
- Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- Adult, Older adult
Study population: HER2-positive early stage breast cancer patients
Who may be able to join
- Women aged ≥18 years and ≤75 years who are newly treated for breast cancer;
- Pathological examination confirmed HER2 positive (immunohistochemical staining ICH+++ or ICH++ and FISH positive);
- Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
- ECOG score 0-1;
- Plan to undergo the final surgical removal of breast cancer, i.e. breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);
- If the major organs function normally, the following criteria are met:
- The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: TBIL≤ upper limit of normal value (ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG <470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized, they should consent to abstinence or use an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment.
- 8. Volunteer to join the study and sign the informed consent.
Who cannot join
- Known allergic history of the drug components of this protocol;
- Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
- Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
- Stage IV (metastatic) breast cancer patients;
- Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
- Serious heart disease or discomfort that cannot be treated;
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- Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
- Pregnant or lactating women;
- Patients with severe liver and kidney function diseases and blood system diseases;
- Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Poor compliance and refusal to cooperate with treatment
About this study
Official title: An Exploratory Clinical Study of the PRO of Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer
This study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of HER2-positive early breast cancer
- Conditions
- HER2+ Breast Cancer
- Being tested
- Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab intravenous drip/Trastuzumab Subcutaneous InjectionDrug
Group A is Trastuzumab intravenous drip,Group B is Trastuzumab Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | The patient received six cycles of neoadjuvant therapy (pyrotinib and trastuzumab purplitol and platinum-based drugs) and underwent radical mastectomy (breast-conserving surgery or total mastectomy) after treatment. After the operation, the doctor will give the corresponding treatment according to the results of the postoperative medical examination Receives: Drug: Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection | |
| Group B | The patient went on to complete six cycles of neoadjuvant therapy (pyrotinib and trastuzumab) and underwent radical mastectomy (breast-conserving surgery or total mastectomy) after treatment. After the operation, the doctor will give the corresponding treatment according to the results of the postoperative medical examination Receives: Drug: Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-C30 scale score
PRO scale scores between two groups collected at different time points
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
tpCR
total pathological complete response
Measured: 1-2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2+ 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537674
- Sponsor's protocol ID
- OBU-BC-II-184
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of the PRO of Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06537674
- Acronym / sponsor ID
- OBU-BC-II-184
- Conditions
- HER2+ Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Aug 2024 (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.
This study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of HER2-positive early breast cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Trastuzumab intravenous drip/Trastuzumab Subcutaneous InjectionThe patient received six cycles of neoadjuvant therapy (pyrotinib and trastuzumab purplitol and platinum-based drugs) and underwent radical mastectomy (breast-conserving surgery or total mastectomy) after treatment. After the operation, the doctor will give the corresponding treatment according to the results of the postoperative medical examination |
| Group B | – | Drug: Trastuzumab intravenous drip/Trastuzumab Subcutaneous InjectionThe patient went on to complete six cycles of neoadjuvant therapy (pyrotinib and trastuzumab) and underwent radical mastectomy (breast-conserving surgery or total mastectomy) after treatment. After the operation, the doctor will give the corresponding treatment according to the results of the postoperative medical examination |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- HER2-positive early stage breast cancer patients
Key inclusion criteria (8 listed)
- Women aged ≥18 years and ≤75 years who are newly treated for breast cancer;
- Pathological examination confirmed HER2 positive (immunohistochemical staining ICH+++ or ICH++ and FISH positive);
- Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
- ECOG score 0-1;
- Plan to undergo the final surgical removal of breast cancer, i.e. breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);
Key exclusion criteria (10 listed)
- Known allergic history of the drug components of this protocol;
- Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
- Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;
- Stage IV (metastatic) breast cancer patients;
- Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;
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 |
|---|---|---|
| Trastuzumab intravenous drip/Trastuzumab Subcutaneous InjectionGroup A is Trastuzumab intravenous drip,Group B is Trastuzumab Subcutaneous Injection | Drug | Group A, Group B |
Primary outcome
EORTC QLQ-C30 scale score
Time frame: through study completion, an average of 1 year
PRO scale scores between two groups collected at different time points
1 secondary outcome
tpCR
Time frame: 1-2 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2+ Breast Cancer, run by Jiangsu Famous Medical Technology Co., Ltd..
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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-C30 scale score (time frame: through study completion, an average of 1 year). 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 5 Aug 2024.