Overview

Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer

Status:
Unknown status
Trial end date:
2020-02-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Albumin-Bound Paclitaxel
Antineoplastic Agents
Cyclophosphamide
Epirubicin
Paclitaxel
Criteria
Inclusion Criteria:

1. Age: from 18 to 70 years old, female.

2. Has histologically or cytologically confirmed unilateral primary invasive breast
cancer with a clinical stage of T2-4NanyM0.

3. 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.

4. At least one measurable objective lesion according to RECIST 1.1 criteria.

5. ECOG performance status of 0-1.

6. LVEF≥55%.

7. Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥
90 g/L.

8. 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.

9. Has good compliance with the planned treatment, understand the study process and sign
written informed consent.

Exclusion Criteria:

1. Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation
therapy.

2. Patients with grade II or higher heart disease scored by the New York Heart
Association (NYHA).

3. Severe systemic infection, or with other serious diseases.

4. Patients with known hypersensitivity or intolerance to chemotherapeutic agents or
their excipients.

5. Other malignancies have occurred in the past 5 years, except for cured cervical
carcinoma in situ, non-melanoma skin carcinoma.

6. Pregnant or lactating, and who refuse to take appropriate contraception during the
course of this trial.

7. Have participated in other study studies within 30 days prior to the first dose of
study drug.

8. Patients who, in the opinion of the Investigator, are not suitable for participation
in the study.