Breast CancerPhase 1NCT06770296
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase I Clinical Study
A Phase 1 study testing Pyrotinib low dose group and Pyrotinib normal dose group in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Evaluate the safety and efficacy of Pyrotinib at different doses in combination with trastuzumab and paclitaxel chemotherapy for first-line treatment of HER2-positive advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pyrotinib low dose group and Pyrotinib normal dose group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2028
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joins the study and signs the informed consent;
- Subject is an adult female or male ≥ 18 years old and ≤ 75 years old at the time of informed consent;
- HER2-positive advanced breast cancer confirmed by pathology:HER2-positive was defined as >10% of immunoreactive cells with an immunohistochemical (IHC) score of 3+ or HER2 gene amplification as a result of in situ hybridization (ISH). HER2 positivity should be verified by the pathology department of the research center;
- Recurrent or metastatic breast cancer; Patients with local recurrence had to be confirmed by the investigator as not amenable to curative resection;
- At least one measurable lesion or only bone metastases according to RECIST v1.1 criteria (including osteolytic lesions or mixed osteolytic/osteoblastic lesions);
- When randomized, Eastern Cooperative Oncology Group(ECGO) physical fitness status is 0 or 1 point;
- Vital organ function meets the following requirements (excluding the use of any blood components and cell growth factors during screening) : Absolute neutrophil (ANC) count ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥9g/dL; Total Bilirubin(TBIL) ≤ULN((Known patients with Gilbert's syndrome:Total Bilirubin(TBIL) ≤2×ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN(Patients with liver metastasis:ALT and AST≤5×ULN); Alkaline phosphatase (AKP) ≤ 2.5 times ULN; Blood Urea Nitrogen and Serum creatinine (Cr) ≤1.5×ULN;Left Ventricular Ejection Fractions(LVEF)≥50%;Corrected QT Interval(QTcF)<470msec.
Who cannot join
- The patient has received any systemic antitumor therapy at the stage of recurrence/metastasis, including any agents targeting EGFR or HER2, systemic chemotherapy, immunotherapy, and more than first-line endocrine therapy, as well as other antitumor therapies deemed by the investigators to be excluded;
- Tyrosine kinase inhibitor (TKI) preparations or macromolecular antibodies against HER have been used at any stage of breast cancer, except for trastuzumab in the (new) adjuvant stage;
- In the stage of breast cancer (new) adjuvant therapy, the time interval from the end of systemic therapy (except endocrine therapy) to the discovery of recurrence/metastasis is <12 months;
- Patients with active brain metastases with pial metastases confirmed by MRI or lumbar puncture (brain metastases requiring mannitol treatment or with symptoms);
- Grade≥ 3 peripheral neuropathy according to CTCAE4.0.3 criteria;
- Patients judged by the investigators to be unsuitable for systematic chemotherapy;
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- Use of endocrine therapy drugs within 7 days prior to randomization;
- Patients with other malignancies within the previous 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma (patients with other malignancies occurring more than 5 years after randomization, such as those cured only by surgery, are allowed to be included);
- Had a major surgical procedure or significant trauma within 4 weeks prior to randomization, or was expected to undergo major surgery;
- Serious heart disease or discomfort, including but not limited to the following:
- Previous history of heart failure or systolic dysfunction (LVEF<50%) High-risk or treatment-requiring angina pectoris or arrhythmias (e.g., second-degree type 2 atrioventricular block or third-degree atrioventricular block, ventricular tachycardia) Clinically significant valvular heart disease ECG showed transmural myocardial infarction Poor hypertension control (systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg);
- Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting the administration and absorption of medications;
- Known allergic history of the drug components of this protocol;
- A history of immunodeficiency, including HIV infection, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods (e.g., pleural fluid and ascites);
- Pregnant and lactating female subjects, or fertile subjects who were unwilling to use effective contraception throughout the trial period and within 3 months after the last study dose;
- Have a serious concomitant disease or other co-medical condition that interferes with planned treatment or any other condition that is not suitable for participation in this study, such as active hepatitis B, a lung infection requiring treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Yongmei Yin, Ph.D, 025-68307102, ymyin@njmu.edu.cn
About this study
Official title: Pyrotinib at Different Doses in Combination With Trastuzumab and Paclitaxel Chemotherapy for First-Line Treatment of HER2-Positive Advanced Breast Cancer: A Multicenter, Randomized, Double-Cohort Study
Evaluate the safety and efficacy of Pyrotinib at different doses in combination with trastuzumab and paclitaxel chemotherapy for first-line treatment of HER2-positive advanced breast cancer.
Read the detailed description
This study is planned to include 200 patients with HER2-positive advanced breast cancer meeting the admission criteria between 2024-11-01 and 2026-11-01. Statistical software will be used by the randomization officers for 1:1 allocation to pyrotinib 320mg in combination with trastuzumab and paclitaxel chemotherapy group and pyrotinib 400mg in combination with trastuzumab and paclitaxel chemotherapy group.
- Conditions
- Breast Cancer
- Being tested
- Pyrotinib low dose group, Pyrotinib normal dose group
- Keywords
- HER2 positive, Pyrotinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib low dose groupDrug
Pyrotinib: 320mg, peros(po),once a day(qd) ,every 3 weeks(q3w) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2，intravenous(iv), every 3 weeks(q3w)
Pyrotinib normal dose groupDrug
Pyrotinib: 400mg, peros(po),once a day(qd) ,every 3 weeks(q3w) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2，intravenous(iv), every 3 weeks(q3w)
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib low dose group | Experimental | Pyrotinib: 320mg , peros(po) , once a day(qd) , every 3 weeks(q3w) Receives: Drug: Pyrotinib low dose group |
| Pyrotinib normal dose group | Active comparator | Pyrotinib: 400mg , peros(po) , once a day(qd) , every 3 weeks(q3w) Receives: Drug: Pyrotinib normal dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate refers to the percentage of the total number of subjects in the analyzed data set who achieved the best response of CR or PR from the beginning of the study treatment to the time of the subject's disease progression group. Response Evaluation criteria in Solid Tumors (RECIST 1.1) was recommended to assess objective tumor response. Participants had to have measurable tumor lesions at baseline, and the response evaluation criteria were recommended as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1 criteria.
Measured: From the time of initiation of treatment in this study to the time of disease progression in the subjects,assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Xuzhou, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, The Second People's Hospital of Changshu, Shuyang County Traditional Chinese Medicine Hospital, Affiliated Hospital of Nantong University, Affiliated Hospital of Jiangsu University, The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Yongmei Yin, Ph.D, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770296
- Sponsor's protocol ID
- Photine-01
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrotinib at Different Doses in Combination With Trastuzumab and Paclitaxel Chemotherapy for First-Line Treatment of HER2-Positive Advanced Breast Cancer: A Multicenter, Randomized, Double-Cohort Study
- ClinicalTrials.gov ID
- NCT06770296
- Acronym / sponsor ID
- Photine-01
- Conditions
- Breast Cancer
- Keywords
- HER2 positive, Pyrotinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The First People's Hospital of Xuzhou, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, The Second People's Hospital of Changshu, Shuyang County Traditional Chinese Medicine Hospital, Affiliated Hospital of Nantong University, Affiliated Hospital of Jiangsu University, The Affiliated Hospital of Xuzhou Medical University
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 13 Jan 2025 (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.
Evaluate the safety and efficacy of Pyrotinib at different doses in combination with trastuzumab and paclitaxel chemotherapy for first-line treatment of HER2-positive advanced breast cancer.
Detailed description
This study is planned to include 200 patients with HER2-positive advanced breast cancer meeting the admission criteria between 2024-11-01 and 2026-11-01. Statistical software will be used by the randomization officers for 1:1 allocation to pyrotinib 320mg in combination with trastuzumab and paclitaxel chemotherapy group and pyrotinib 400mg in combination with trastuzumab and paclitaxel chemotherapy group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib low dose group | Experimental | Drug: Pyrotinib low dose groupPyrotinib: 320mg , peros(po) , once a day(qd) , every 3 weeks(q3w) |
| Pyrotinib normal dose group | Active comparator | Drug: Pyrotinib normal dose groupPyrotinib: 400mg , peros(po) , once a day(qd) , every 3 weeks(q3w) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subjects voluntarily joins the study and signs the informed consent;
- Subject is an adult female or male ≥ 18 years old and ≤ 75 years old at the time of informed consent;
- HER2-positive advanced breast cancer confirmed by pathology:HER2-positive was defined as >10% of immunoreactive cells with an immunohistochemical (IHC) score of 3+ or HER2 gene amplification as a result of in situ hybridization (ISH). HER2 positivity should be verified by the pathology department of the research center;
- Recurrent or metastatic breast cancer; Patients with local recurrence had to be confirmed by the investigator as not amenable to curative resection;
- At least one measurable lesion or only bone metastases according to RECIST v1.1 criteria (including osteolytic lesions or mixed osteolytic/osteoblastic lesions);
Key exclusion criteria (17 listed)
- The patient has received any systemic antitumor therapy at the stage of recurrence/metastasis, including any agents targeting EGFR or HER2, systemic chemotherapy, immunotherapy, and more than first-line endocrine therapy, as well as other antitumor therapies deemed by the investigators to be excluded;
- Tyrosine kinase inhibitor (TKI) preparations or macromolecular antibodies against HER have been used at any stage of breast cancer, except for trastuzumab in the (new) adjuvant stage;
- In the stage of breast cancer (new) adjuvant therapy, the time interval from the end of systemic therapy (except endocrine therapy) to the discovery of recurrence/metastasis is <12 months;
- Patients with active brain metastases with pial metastases confirmed by MRI or lumbar puncture (brain metastases requiring mannitol treatment or with symptoms);
- Grade≥ 3 peripheral neuropathy according to CTCAE4.0.3 criteria;
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 |
|---|---|---|
| Pyrotinib low dose groupPyrotinib: 320mg, peros(po),once a day(qd) ,every 3 weeks(q3w) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2，intravenous(iv), every 3 weeks(q3w) | Drug | Pyrotinib low dose group |
| Pyrotinib normal dose groupPyrotinib: 400mg, peros(po),once a day(qd) ,every 3 weeks(q3w) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2，intravenous(iv), every 3 weeks(q3w) | Drug | Pyrotinib normal dose group |
Primary outcome
Objective Response Rate
Time frame: From the time of initiation of treatment in this study to the time of disease progression in the subjects,assessed up to 100 months.
Objective Response Rate refers to the percentage of the total number of subjects in the analyzed data set who achieved the best response of CR or PR from the beginning of the study treatment to the time of the subject's disease progression group. Response Evaluation criteria in Solid Tumors (RECIST 1.1) was recommended to assess objective tumor response. Participants had to have measurable tumor lesions at baseline, and the response evaluation criteria were recommended as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1 criteria.
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 13 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Yongmei Yin, Ph.D study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pyrotinib low dose group and Pyrotinib normal dose group in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 7 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yongmei Yin, Ph.D (025-68307102, ymyin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From the time of initiation of treatment in this study to the time of disease progression in the subjects,assessed up to 100 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 13 Jan 2025.