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New treatment option for HER2-positive Breast Cancer
Official title Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer
ClinicalTrials.gov ID: NCT07647263
What this study is testing
What is THP Regimen (Taxane + Trastuzumab + Pertuzumab)?
THP Regimen (Taxane + Trastuzumab + Pertuzumab) is an investigational medicine, being studied as a potential treatment for her2-positive breast cancer.
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
- This study is a response-adapted, multicenter, interventional trial enrolling patients with HER2-positive early or locally advanced breast cancer. All enrolled patients will first receive 2 cycles of standard neoadjuvant THP regimen, consisting of a taxane, trastuzumab, and pertuzumab.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 1.Age ≥18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and the patient must agree to use effective...
- 2.Pathologically confirmed invasive breast cancer, stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM...
- 3.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- 4.No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.
- 5.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
You likely can't join if
- 1.Male breast cancer or inflammatory breast cancer.
- 2.Metastatic breast cancer (Stage IV).
- 3.Presence of other concurrent malignancies or history of malignancy other than breast cancer within the past 5 years, except for adequately treated...
- 4.Receipt of any other concurrent anti-cancer therapy or participation in another clinical trial.
- 5.Presence of severe non-malignant disease that would compromise patient compliance or place the patient at unacceptable risk.
- 6.Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipated need for major surgery during the study period.
See the full eligibility criteria
- 1.Age ≥18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and the patient must agree to use effective contraception during treatment.
- 2.Pathologically confirmed invasive breast cancer, stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2-positive disease defined as...
- 3.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- 4.No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.
- 5.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- 6.Ability to understand and provide written informed consent.
- 7.Adequate organ function as evidenced by the following laboratory values:
- Hemoglobin ≥90 g/L
- White blood cell count ≥3.5×10⁹/L
- Platelet count ≥100×10⁹/L
- Neutrophil count ≥1.5×10⁹/L
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3× upper limit of normal (ULN)
- Total bilirubin ≤1.5×ULN
- Serum creatinine ≤1.5×ULN
- 8.No evidence of myocardial ischemia on electrocardiogram (ECG); New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥55% on echocardiogram; cardiac biomarkers (cardiac...
- 9.All required baseline laboratory and radiologic examinations completed prior to neoadjuvant therapy.
- 10.No dysphagia.
- 11.Availability of complete clinical data.
- 1.Male breast cancer or inflammatory breast cancer.
- 2.Metastatic breast cancer (Stage IV).
- 3.Presence of other concurrent malignancies or history of malignancy other than breast cancer within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or...
- 4.Receipt of any other concurrent anti-cancer therapy or participation in another clinical trial.
- 5.Presence of severe non-malignant disease that would compromise patient compliance or place the patient at unacceptable risk.
- 6.Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipated need for major surgery during the study period.
- 7.Receipt of radiotherapy, chemotherapy, molecular targeted therapy, endocrine therapy, or major breast surgery for breast cancer within 4 weeks prior to study treatment; current or prior use of HER2-targeted monoclonal...
- 8.History of hypersensitivity or contraindication to any component of the study drugs.
- 9.Poorly controlled cardiac symptoms or diseases, including: New York Heart Association (NYHA) Class II or higher heart failure; unstable angina; myocardial infarction within 1 year; clinically significant...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, 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.