A Phase 2 interventional study of epirubicin hydrochloride and Cyclophosphamide in Triple Negative Breast Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
This study is to evaluate the efficacy and safety for dose-dense epirubicin hydrochloride with cyclophosphamide followed by nanoparticlealbumin-bound paclitaxel with PD-1 in neoadjuvant therapy for patients with triple-negative breast cancer, and to explore the predictive value of biological markers for the treatment.
This study is an open single arm study, which would undergo optimal two stage designs. 60 patients who are diagnosed with triple-negative breast cancer would have dose-dense epirubicin hydrochloride with cyclophosphamide followed by nanoparticlealbumin-bound paclitaxel with PD-1 regimen for neoadjuvant therapy if they meet the eligibility criteria. The regimen is as follows: epirubicin hydrochloride (90mg/m2, d1) plus cyclophosphamide (600mg/m2, d1) every 14 days as one cycle for 4 cycles, followed by nanoparticlealbumin-bound paclitaxel (125mg/m2, d1) per week for 3 weeks as one cycle for 4 cycles, and Toripalimab (240mg, d1) every 3 weeks as one cycle for 4 cycles. pathological complete response would be the primary endpoint. The change of biological markers and safety of the regimen would also be evaluated.
1,163 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.
This study's enrollment of 70 is above the median of 61 across 1,001 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.
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Exclusion Criteria:
Patients who are treated with epirubicin hydrochloride andcyclophosphamide followed by nanoparticlealbumin-bound paclitaxel and Toripalimab
Drug: epirubicin hydrochloride · Drug: Cyclophosphamide · Drug: Albumin bound paclitaxel · Drug: Toripalimab
Take epirubicin hydrochloride (90mg/m2, d1) every 14 days as one cycle for 4 cycles with cyclophosphamide, followed by nanoparticlealbumin-bound paclitaxel and Toripalimab.
Take cyclophosphamide (600mg/m2, d1) every 14 days as one cycle for 4 cycles with epirubicin hydrochloride, followed by nanoparticlealbumin-bound paclitaxel and Toripalimab.
Take nanoparticlealbumin-bound paclitaxel (125mg/m2, d1) per week for 3 weeks as one cycle for 4 cycles with Toripalimab, following epirubicin hydrochloride and cyclophosphamide.
Take Toripalimab (240mg, d1) every 3 weeks as one cycle for 4 cycles with nanoparticlealbumin-bound paclitaxel, following epirubicin hydrochloride and cyclophosphamide.
Total Pathologic complete response (tpCR)
Defined as no residual invasive cancer cells are found in the pathological examination of breast and axillary lymph node; if only residual in situ cancer cells are present in the surgical specimens, it can also be considered as achieving a pathological complete response.
Time frame: Immediately after the surgery
Breast pathologic complete response (bpCR: ypT0/is) rate
Defined as the absence of invasive cancer cells in breast.
Time frame: Immediately after the surgery
Objective response rate (ORR)
Defined as the proportion of patients with a complete or partial response by MRI.
Time frame: Immediately after the surgery
Breast conservative surgery rate
Defined as the percentage of patients who undergo breast-conserving surgery after neoadjuvant therapy, out of the total number of evaluable cases.
Time frame: Immediately after the surgery
Event-free survival (EFS)
Defined as the time from the date of the first study dose to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Time frame: Approximately 3 years
Adverse events (AEs)
Refer to any untoward medical occurrence in a study subject administered an investigational product which does not necessarily have a causal relationship with the treatment. AE is assessed according to the NCI-CTCAE 5.0.
Time frame: During this period between the start of randomization and the last visit, approximately 3 years
Change in immune-related tissue biomarkers
The proportion of Tumor-infiltrating lymphocytes (TILs) is evaluated through HE staining. Immunohistochemical staining of PD-1, PD-L1, AR, CD8, and FOXC1) is performed. TILs, PD1, PD-L1, AR, CD8, and FOXC1 in tumor samples by biopsy at baseline, at the end of Cycle 2 and by surgery immediately after surgery would be evaluated by HE or immune staining.
Time frame: At baseline, at the end of first 2 cycles (each cycle is 14 days) and immediately after the surgery
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Toripalimab
Triple Negative Breast Neoplasms →