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Tests treatment safety and results for Breast Cancer,HER2-positive
Official title A Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
ClinicalTrials.gov ID: NCT04547907
What this study is testing
What is Nab-paclitaxel+ trastuzumab+ patuzumab?
Nab-paclitaxel+ trastuzumab+ patuzumab is an investigational medicine, given as an once-weekly, being studied as a potential treatment for breast cancer,her2-positive.
Also referred to as nab-PHP regimen group.
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
- The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
- Phase 3: a large, late-stage study
- 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
- Age: 18-70 years;
- Clinical T2-T4d, or T1c with axillary lymph node positivity;
- Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+...
- Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization;
- No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy:
You likely can't join if
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease;
- Patients with a second primary malignancy, except for adequately treated skin cancer;
- Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such...
- Severe heart disease or conditions that do not allow participation in the study, including but not limited to the following:
See the full eligibility criteria
- Age: 18-70 years;
- Clinical T2-T4d, or T1c with axillary lymph node positivity;
- Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+ or, if IHC 2+, by HER2 gene amplification as demonstrated by...
- Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization;
- No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy:
- Neutrophil count absolute value ≧2.0×109/L;
- Hemoglobin ≧ 100g/L;
- Platelet count ≧100×109/L;
- Total bilirubin \<1.5 ULN (upper limit of normal);
- Creatinine \< 1.5×ULN
- AST/ALT \< 1.5×ULN;
- Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%);
- Reproductive age women, negative serum pregnancy test within 14 days before randomization;
- ECOG score 0 or 1;
- Signature of informed consent.
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease;
- Patients with a second primary malignancy, except for adequately treated skin cancer;
- Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such surgical procedures;
- Severe heart disease or conditions that do not allow participation in the study, including but not limited to the following:
- 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 conduction blocks...
- Angina pectoris requiring anti-anginal drug therapy;
- Clinically significant valvular heart disease;
- ECG showing a transmural myocardial infarction;
- Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg);
- Due to severe and uncontrolled other medical conditions, the investigator considers chemotherapy to be contraindicated;
- Known history of allergy to any component of the study drugs; patients with a history of immune deficiency diseases, including HIV positivity, or patients with other acquired or congenital immune deficiency diseases, or...
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 70 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.