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

Phase 2

Completed

• Conditions: Tubular Breast Cancer; Mucinous Breast Cancer; Invasive Ductal Breast Cancer; Inflammatory Breast Cancer
• Interventions: Drug: Paclitaxel; Drug: Cisplatin

• Registration Number: NCT02199418
• Lead Sponsor: RenJi Hospital

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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Primary Completion: 2015-11
• Study Completion: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel and Cisplatin	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
Paclitaxel and Cisplatin	Paclitaxel	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

Primary Outcome Measures

Name	Time	Method
Pathological complete response of breast and lymph nodes	after 4 months preoperative treatment

Secondary Outcome Measures

Name	Time	Method
local recurrence free survival (LRFS)	5 years	LRFS is defined as the time period between registration and first event
regional recurrence free survival (RRFS)	5 years	RRFS 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
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
distant-disease- free survival (DDFS)	5 years	DFS is defined as the time period between registration and first event

Trial Locations

Locations (2)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Shanghai Jiaotong University School of Medicine, Renji Hospital; 🇨🇳 Shanghai, Shanghai, China