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New treatment option for HR+/HER2- Breast Cancer
Official title Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)
ClinicalTrials.gov ID: NCT06874933
What this study is testing
What is Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart?
Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hr+/her2- 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
- Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
- 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
- Female patients aged between 18 and 75 years old.
- With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Patients with histologically or pathologically confirmed invasive ductal carcinoma of the breast, and simultaneously meeting the following...
- The functional levels of the major organs must meet the following requirements (no blood transfusion, and no use of drugs for increasing white blood...
- Blood routine: Absolute neutrophil count (ANC) \> 1.5×10⁹/L; platelet count (PLT) \> 75× 10⁹/L; hemoglobin (Hb) \> 90 g/L; lymphocyte count ≥...
You likely can't join if
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Have previously received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured malignant tumors such as carcinoma in situ of...
- Simultaneously receiving anti-tumor treatment in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological...
- Having undergone a major surgical procedure unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the...
- Severe heart diseases or disorders, including but not limited to the following diseases: A confirmed history of heart failure or systolic dysfunction...
See the full eligibility criteria
- Female patients aged between 18 and 75 years old.
- With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Patients with histologically or pathologically confirmed invasive ductal carcinoma of the breast, and simultaneously meeting the following conditions: T1c (≥1 cm) - 4c N0-2; Histologically confirmed as grade 3 by the...
- The functional levels of the major organs must meet the following requirements (no blood transfusion, and no use of drugs for increasing white blood cells or platelets within 2 weeks before screening):
- Blood routine: Absolute neutrophil count (ANC) \> 1.5×10⁹/L; platelet count (PLT) \> 75× 10⁹/L; hemoglobin (Hb) \> 90 g/L; lymphocyte count ≥ 1.5×10⁹/L.
- Blood biochemistry: Total bilirubin (TBIL) \< 1.5× the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 1.5×ULN; alkaline phosphatase \< 2.5×ULN; blood urea...
- Echocardiogram: Left ventricular ejection fraction (LVEF) \> 55%.
- 12-lead electrocardiogram: The corrected QT interval using the Fridericia method (QTcF) \< 470 msec.
- For premenopausal female patients or those who have not undergone surgical sterilization: Use an effective contraceptive method during the treatment period and for at least 6 months after the last administration of the...
- Voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with the follow-up.
- Stage IV breast cancer.
- Inflammatory breast cancer.
- Have previously received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma.
- Simultaneously receiving anti-tumor treatment in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone-modifying drug therapy, or immune checkpoint inhibitor...
- Having undergone a major surgical procedure unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such a surgical procedure.
- Severe heart diseases or disorders, including but not limited to the following diseases: A confirmed history of heart failure or systolic dysfunction (left ventricular ejection fraction [LVEF] less than 50%). High-risk...
- Uncontrolled active infections that require treatment; a history of immunodeficiency, including a positive HIV test result, or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ...
- Patients with active chronic hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, patients with stable hepatitis B after drug treatment [negative HBV-DNA test or \< 50 IU/ml], and cured hepatitis C...
- Have previously received immunotherapy and experienced immune-related adverse events such as immune-related pneumonia or myocarditis, which, as determined by the investigator, may affect the safety of the study drug.
- Known history of allergy to the components of this treatment regimen.
- Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test result, or patients of childbearing age who are unwilling to use effective contraceptive measures...
- Suffering from severe concomitant diseases or other comorbidities that may interfere with the planned treatment, or any other situation in which the investigator deems the patient unsuitable for participating in this...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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, Zhejiang, 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.