Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer

Phase 2CompletedNCT02199418

RenJi Hospital132 enrolled

Overview

The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.

In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Tubular Breast Cancer Mucinous Breast Cancer Invasive Ductal Breast Cancer Inflammatory Breast Cancer

Interventions

PaclitaxelDRUG

CisplatinDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women aged ≥18years and ≤70 years 2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-2M0 3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as \>1% stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH ratio ≥ 2.0 4. No prior systemic or loco-regional treatment of breast cancer 5. ECOG 0-2 6. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit （UNL）, creatinine≤1.5 UNL, bilirubin≤1.5UNL 7. No obvious main organs dysfunction Exclusion Criteria: 1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug 2. Patient is pregnant or breast feeding 3. Inflammatory breast cancer and metastatic breast cancer 4. Any evidence of sense or motor nerve disorders 5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection 6. Any concurrent malignancy other than breast cancer 7. Know severe hypersensitivity to any drugs in this study

Locations (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Pathological complete response of breast and lymph nodes

Time frame: after 4 months preoperative treatment

Secondary Outcomes

Tolerability and Safety

Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped

Time frame: 4 months during neoadjuvant therapy

Clinical and imaging response

To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment

Time frame: 4 months during treatment

regional recurrence free survival (RRFS)

RRFS is defined as the time period between registration and first event

Time frame: 5 years

local recurrence free survival (LRFS)

LRFS is defined as the time period between registration and first event

Time frame: 5 years

distant-disease- free survival (DDFS)

DFS is defined as the time period between registration and first event

Time frame: 5 years

overall survival (OS)

OS is defined as the time period between registration and first event

Time frame: 5 years

Data from ClinicalTrials.gov

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