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New treatment option for HR Positive/HER2 Low Breast Cancer
Official title Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)
ClinicalTrials.gov ID: NCT07383818
What this study is testing
What is Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab?
Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hr positive/her2 low 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 prospective, multi-cohort, multicenter, open-label exploratory clinical trial. The primary study objective is to evaluate the pathologic complete response (PCR) of treatment of HR+/HER2-low breast cancer with neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab , including the incidences and types of adverse events.
- 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, women only
You may be able to join if
- Female patients aged 18-70 years old;
- ECOG score is 0-1 points;
- Histologically or pathologically confirmed invasive breast cancer, meeting the following criteria simultaneously: Invasive breast cancer staged as...
- Function levels of major organs must meet the required criteria
- For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment...
You likely can't join if
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as...
- Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment...
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or...
- Serious heart disease or discomfort.
See the full eligibility criteria
- Female patients aged 18-70 years old;
- ECOG score is 0-1 points;
- Histologically or pathologically confirmed invasive breast cancer, meeting the following criteria simultaneously: Invasive breast cancer staged as T1cN1-2M0 or T2-3N0-2M0; All patients must be pathohistologically...
- Function levels of major organs must meet the required criteria
- For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months...
- Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell...
- Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune...
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.
- Serious heart disease or discomfort.
- Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of...
- Patients with chronic active hepatitis B or active hepatitis C
- Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental...
- Individuals with a known history of allergies to the components of this medication regimen.
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, China
- Hefei, China
- Shanghai, China
- Xi'an, China
- Zhengzhou, 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 Harbin, China; Hefei, China; Shanghai, China; Xi'an, China; Zhengzhou, 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.