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New treatment option for Breast Cancer
Official title Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
ClinicalTrials.gov ID: NCT06500208
What this study is testing
What is Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide?
Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide is an investigational medicine, being studied as a potential treatment for 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
- Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.
- 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 65, women only
You may be able to join if
- pathologically diagnosed as unilateral primary invasive breast cancer with a) cT1c-T2N1-3 or cT3-4N0-3, b) Tumor Grade 3 or Grade 2 with PR- or Ki67...
- IHC ER expression ≥1%; IHC HER2 0 or 1+; IHC HER2 2+ and no amplification in FISH test;
- At least one measurable lesion according to RECIST 1.1;
- Available core needle biopsy samples for PD-L1 status testing;
- ECOG 0 or 1 within 10 days prior to initiation of treatment;
You likely can't join if
- Bilateral invasive breast cancer or Stage IV breast cancer;
- Severe heart disease;
- Diagnosed as immune deficiency or receiving systemic steroid therapy or any form of immuno-suppressive therapy within 7 days prior to the first dose...
- Had active autoimmune diseases requiring systemic therapy within the past 2 years;
- Severe systemic infections or other serious medical conditions;
- Other malignant tumors in the past 5 years, except for cured carcinoma in situ of the cervix and skin cancer without melanoma;
See the full eligibility criteria
- pathologically diagnosed as unilateral primary invasive breast cancer with a) cT1c-T2N1-3 or cT3-4N0-3, b) Tumor Grade 3 or Grade 2 with PR- or Ki67 \> 20%;
- IHC ER expression ≥1%; IHC HER2 0 or 1+; IHC HER2 2+ and no amplification in FISH test;
- At least one measurable lesion according to RECIST 1.1;
- Available core needle biopsy samples for PD-L1 status testing;
- ECOG 0 or 1 within 10 days prior to initiation of treatment;
- Not currently pregnant or breastfeeding, agree to strict contraception during treatment and at least 6 months after last dose;
- Intact hematologic, liver, renal and heart functions;
- Signed written informed consent.
- Bilateral invasive breast cancer or Stage IV breast cancer;
- Severe heart disease;
- Diagnosed as immune deficiency or receiving systemic steroid therapy or any form of immuno-suppressive therapy within 7 days prior to the first dose of treatment;
- Had active autoimmune diseases requiring systemic therapy within the past 2 years;
- Severe systemic infections or other serious medical conditions;
- Other malignant tumors in the past 5 years, except for cured carcinoma in situ of the cervix and skin cancer without melanoma;
- History of HIV infection;
- Active HBV or HCV infection;
- Known allergies or intolerance to the therapeutic drug or its excipients;
- History of application of any immunotherapy targeting PD-1/PD-L1/T cell receptors;
- Judged by the investigator to be unsuitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.