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New treatment option for HER2-positive Early Breast Cancer
Official title Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer
ClinicalTrials.gov ID: NCT07340398
What this study is testing
What is Nab paclitaxel?
Nab paclitaxel is an investigational medicine, being studied as a potential treatment for her2-positive early 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 prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After receiving neoadjuvant dual-HER2-targeted therapy with chemotherapy, patients are evaluated for their treatment response.
- 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 to 75, women only
You may be able to join if
- Age ≥18 and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Primary tumor size \>1 cm.
- Histologically confirmed invasive breast cancer, clinically staged as:
- Stage I (T1cN0M0)
You likely can't join if
- Prior anti-tumor therapy for breast cancer, including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy.
- Concurrent administration of any other anti-tumor treatment.
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
- Breast cancer not confirmed histologically.
- History of other malignancy within the past 5 years, except successfully treated cervical carcinoma in situ.
- Severe dysfunction of major organs (heart, liver, kidney).
See the full eligibility criteria
- Age ≥18 and ≤75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Primary tumor size \>1 cm.
- Histologically confirmed invasive breast cancer, clinically staged as:
- Stage I (T1cN0M0)
- Stage II (T1cN1M0, T2N0-1M0 or T3N0M0)
- Stage III (T2N2-3M0, T3N1-3M0, or T4N0-3M0)
- HER2-positive status: IHC 3+ or IHC 2+ with positive ISH.
- Adequate major organ function:
- Hematology (no transfusion or hematopoietic growth factors, e.g., G-CSF, within 14 days):
- Hemoglobin ≥100 g/L
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
- Platelet count ≥100 × 10⁹/L
- Biochemistry:
- Total bilirubin ≤1.5 × ULN
- ALT and AST ≤1.5 × ULN; ALP ≤2.5 × ULN
- BUN and creatinine ≤1.5 × ULN
- Cardiac function: LVEF ≥55% by echocardiography
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study and for 8 weeks after the last dose.
- Voluntary written informed consent and willingness to comply with study procedures and follow-up.
- Prior anti-tumor therapy for breast cancer, including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy.
- Concurrent administration of any other anti-tumor treatment.
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer.
- Breast cancer not confirmed histologically.
- History of other malignancy within the past 5 years, except successfully treated cervical carcinoma in situ.
- Severe dysfunction of major organs (heart, liver, kidney).
- Conditions affecting oral drug administration or absorption, e.g., inability to swallow, chronic diarrhea, or intestinal obstruction.
- Participation in another investigational drug trial within 4 weeks prior to enrollment.
- Known hypersensitivity to study drug components; history of immunodeficiency (HIV positive, active HCV, active hepatitis B, other congenital/acquired immunodeficiency) or prior organ transplantation.
- History of clinically significant cardiac disease, including:
- Arrhythmia requiring medication
- Myocardial infarction
- Heart failure
- Other cardiac conditions deemed unsuitable for study participation by the investigator
- Pregnant or breastfeeding women, or women of childbearing potential who test positive at baseline or are unwilling to use effective contraception throughout the study.
- Any condition that, in the investigator's judgment, poses serious risk to patient safety or may interfere with study completion (e.g., uncontrolled severe hypertension, uncontrolled diabetes, active infection).
- History of neurological or psychiatric disorders (e.g., epilepsy or dementia) or any other condition the investigator considers incompatible with study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, 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.