Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination With Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Fudan University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The primary endpoint is pathological complete remission (pCR)
Study Overview
Brief Summary
This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.
The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer.
The primary endpoint of the study is to to assess Pathological complete response rate（pCR）using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)..
The total number of patients to be included in this study is 60 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 19 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: from 18 to 70 years old, female.
- •Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM
- •The expression of ER, PR, HER-2 was negative by immunohistochemistry (IHC), if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification.
- •At least one measurable objective lesion according to RECIST 1.1 criteria.
- •ECOG performance status of 0-
- •Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
- •Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
- •Has good compliance with the planned treatment, understand the study process and sign written informed consent.
Exclusion Criteria
- •Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
- •Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
- •Severe systemic infection, or with other serious diseases.
- •Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
- •Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
- •Pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial.
- •Have participated in other study studies within 30 days prior to the first dose of study drug.
- •Patients who, in the opinion of the Investigator, are not suitable for participation in the study.
Arms & Interventions
Chemotherapy
Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1* 12 cycles ( weekly), followed by epirubicin 90mg/m2, iv, d1 + cyclophosphamide 600mg/m2, iv, d1 * 4 cycles (14 days per cycle)
Intervention: Chemotherapeutic Agent (Drug)
Outcomes
Primary Outcomes
The primary endpoint is pathological complete remission (pCR)
Time Frame: 2 months
Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.
Secondary Outcomes
- Adverse events (AE)(2 months)
- The second endpoint includes the objective response rate (ORR)(2 months)
- Breast conserving surgery(BCS) rate(2 months)
Investigators
Zhimin Shao
professor
Fudan University