SHPD001: Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer

Sponsor

RenJi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02199418

Collaborator

(none)

132

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Tubular Breast Cancer Mucinous Breast Cancer Invasive Ductal Breast Cancer Inflammatory Breast Cancer	Drug: Paclitaxel Drug: Cisplatin	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

132 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paclitaxel and Cisplatin Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year	Drug: Paclitaxel Other Names: Taxol Drug: Cisplatin

Arm

Intervention/Treatment

Experimental: Paclitaxel and Cisplatin

Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year

Drug: Paclitaxel

Other Names:

Taxol

Drug: Cisplatin

Outcome Measures

Primary Outcome Measures

Pathological complete response of breast and lymph nodes [after 4 months preoperative treatment]

Secondary Outcome Measures

Tolerability and Safety [4 months during neoadjuvant therapy]
Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped
Clinical and imaging response [4 months during treatment]
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
regional recurrence free survival (RRFS) [5 years]
RRFS is defined as the time period between registration and first event
local recurrence free survival (LRFS) [5 years]
LRFS is defined as the time period between registration and first event
distant-disease- free survival (DDFS) [5 years]
DFS is defined as the time period between registration and first event
overall survival (OS) [5 years]
OS is defined as the time period between registration and first event

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women aged ≥18years and ≤70 years
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
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
No prior systemic or loco-regional treatment of breast cancer
ECOG 0-2
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
No obvious main organs dysfunction

Exclusion Criteria:

Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug
Patient is pregnant or breast feeding
Inflammatory breast cancer and metastatic breast cancer
Any evidence of sense or motor nerve disorders
Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection
Any concurrent malignancy other than breast cancer
Know severe hypersensitivity to any drugs in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032
2	Shanghai Jiaotong University School of Medicine, Renji Hospital	Shanghai	Shanghai	China	200127