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New treatment option for Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Official title SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
ClinicalTrials.gov ID: NCT06927180
What this study is testing
What is SHR-A1811?
SHR-A1811 is an investigational medicine, being studied as a potential treatment for breast cancer early stage breast cancer (stage 1-3).
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 goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are: Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment?
- 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 70
You may be able to join if
- Age: 18-70 years old, ECOG 0-1 point.
- Clinical T2-T4, with any LN, M0.
- 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...
- The presence of uncontrolled cardiovascular and cerebrovascular disease, including (but not limited to) any of the following within the 6 months...
- Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.
See the full eligibility criteria
- Age: 18-70 years old, ECOG 0-1 point.
- Clinical T2-T4, with any LN, M0.
- 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 ≥ 1.5 × 10\^9/L; Hemoglobin ≥ 90g/L; Platelet count ≥ 100 ×...
- Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 50%).
- Women of childbearing age tested negative for serum pregnancy test 7 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.
- The presence of uncontrolled cardiovascular and cerebrovascular disease, including (but not limited to) any of the following within the 6 months prior to the first dose: congestive heart failure (NYHA III or IV)...
- 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 immunodeficiency diseases, or having a history of organ transplantation.
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 all sexes, 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.