Clinical trial NCT03799679: Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer
Official title: Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination With Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Triple Negative Breast Cancer
Keywords: Neoadjuvant Chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer. Patients will treated by Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary endpoint is pathological complete remission (pCR)
timeFrame: 2 months
Secondary outcomes:
measure: The second endpoint includes the objective response rate (ORR)
timeFrame: 2 months
measure: Breast conserving surgery(BCS) rate
timeFrame: 2 months
measure: Adverse events (AE)
timeFrame: 2 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer Hospital/ Institute, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhimin Shao
role: PRINCIPAL_INVESTIGATOR
References: