Status:
UNKNOWN
Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer
Lead Sponsor:
Fudan University
Conditions:
HER-2 Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief Summary
This is an open-label, single arm, two-stage Simon Design study for women with LuminalB/HER-2 Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin. The primary ob...
Eligibility Criteria
Inclusion
- Age: from 18 to 70 years old, female.
- Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
- Immunohistochemical detection of ER+, PR+, HER-2 negative (if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification) and Ki-67 expression \>20% of patients;
- At least one measurable objective lesion according to RECIST 1.1 criteria.
- ECOG performance status of 0-1.
- 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
- 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.
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2019
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT03799692
Start Date
November 19 2018
End Date
July 30 2019
Last Update
January 10 2019
Active Locations (2)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
2
Department of Breast Surgery, Cancer Hospital, Fudan University
Shanghai, China, 200032