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New treatment option for Breast Cancer
Official title The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study
ClinicalTrials.gov ID: NCT06254690
What this study is testing
What is Pyrotinib dose escalation?
Pyrotinib dose escalation is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as Trastuzumab, Docetaxel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- The people voluntarily joins the study and signs the informed consent;
- Subject is an adult female ≥ 18 years old and ≤ 70 years old at the time of informed consent.
- HER2-positive advanced breast cancer confirmed by pathology (HER2-positive expression refers to those with at least one tumor cell...
- Stage IV breast cancer according to American Joint Committee on Cancer(AJCC) staging system version 8.
- people did not receive systemic antitumor therapy at the stage of recurrence/metastasis;
You likely can't join if
- Any previous tyrosine kinase inhibitor therapy against HER2 target;
- Patients with known active central nervous system metastases without surgery or radiation therapy, except those who have been stable for at least 1...
- Pial metastasis confirmed by MRI or lumbar puncture;
- Inflammatory breast cancer or other malignancies within the previous 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ...
- Any antitumor therapy within 4 weeks prior to enrollment;
- Pregnant or breastfeeding women (women of childbearing age must have a negative pregnancy test within 14 days prior to the first dose, if positive...
See the full eligibility criteria
- The people voluntarily joins the study and signs the informed consent;
- Subject is an adult female ≥ 18 years old and ≤ 70 years old at the time of informed consent.
- HER2-positive advanced breast cancer confirmed by pathology (HER2-positive expression refers to those with at least one tumor cell immunohistochemical staining intensity of 3+ or 2+ positive by fluorescence in situ...
- Stage IV breast cancer according to American Joint Committee on Cancer(AJCC) staging system version 8.
- people did not receive systemic antitumor therapy at the stage of recurrence/metastasis;
- At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors version 1.1 criteria
- When assigned by chance, 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...
- Any previous tyrosine kinase inhibitor therapy against HER2 target;
- Patients with known active central nervous system metastases without surgery or radiation therapy, except those who have been stable for at least 1 month after treatment and have been off corticosteroids for \>2 weeks;
- Pial metastasis confirmed by MRI or lumbar puncture;
- Inflammatory breast cancer or other malignancies within the previous 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Any antitumor therapy within 4 weeks prior to enrollment;
- Pregnant or breastfeeding women (women of childbearing age must have a negative pregnancy test within 14 days prior to the first dose, if positive, the pregnancy must be ruled out by ultrasound);
- Patients with gastrointestinal insufficiency or gastrointestinal disease significantly affecting the absorption of the investigational drug (e.g., uncontrolled ulcerative disease, uncontrolled nausea, vomiting...
- Patients with ascites, pleural effusion and pericardial effusion accompanied by clinical symptoms requiring drainage at baseline, or patients with serosal effusion drainage within 4 weeks before the first medication;
- Patients with a history of immunodeficiency, including HIV testing positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Patients with a major surgical procedure or significant trauma within 4 weeks before starting treatment, or expected to undergo major surgery;
- Concomitant medical conditions (e.g., severe hypertension, diabetes, thyroid disease, co-active hepatitis B/C, and other active infections, etc.) that are deemed by the investigator to seriously endanger the patient's...
- Inability to understand or follow research instructions and requirements;
- The investigator considers the patient unsuitable for entry into this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.