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Compares treatment options for Breast Cancer
Official title Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC
ClinicalTrials.gov ID: NCT05918328
What this study is testing
What is Albumin paclitaxel+trastuzumab+pyrrolitinib?
Albumin paclitaxel+trastuzumab+pyrrolitinib is an investigational medicine, given as an once-weekly, being studied as a potential treatment for breast cancer.
Also referred to as Nab-PH+pyrrolitinib regimen.
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
- At present, the incidence rate of breast cancer has exceeded that of lung cancer, becoming the largest cancer in the world. HER2 overexpression breast cancer accounts for about 20%\~30% of all breast cancer patients.
- 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 65, women only
You may be able to join if
- Age: 18-65 years old, ECOG 0-1 point.
- Clinical T2-T4d, or T1c with axillary LN+.
- HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell...
- Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of...
- Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy:Absolute value of neutrophil...
You likely can't join if
- Stage IV (metastatic) breast cancer.
- Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.
- The patient has a second primary malignant tumor, except for fully treated skin cancer.
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully...
- Serious heart disease or discomfort, including but not limited to the following diseases:Confirmed history of heart failure or systolic dysfunction...
- Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.
See the full eligibility criteria
- Age: 18-65 years old, ECOG 0-1 point.
- Clinical T2-T4d, or T1c with axillary LN+.
- HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence...
- Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of randomization.
- Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy:Absolute value of neutrophil count ≥ 2.0 × 109/L; Hemoglobin ≥ 90g/L; Platelet count ≥ 100 ×...
- Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%).
- Women of childbearing age tested negative for serum pregnancy test 14 days before randomization.
- Sign an informed consent form.
- Stage IV (metastatic) breast cancer.
- Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.
- The patient has a second primary malignant tumor, except for fully treated skin cancer.
- The patient had undergone 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:Confirmed history of heart failure or systolic dysfunction (LVEF\ 100 bpm, significant ventricular arrhythmias (such as...
- Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.
- Individuals with a known history of allergies to the drug components of this protocol; Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, 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.