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

Inflammatory Breast Cancer Clinical Trial

— SHPD001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199418
• Other study ID #: RenJiH-BC-001
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2014
• Last updated: January 23, 2017
• Start date: January 2013
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Ductal, Breast
• Inflammatory Breast Cancer
• Invasive Ductal Breast Cancer
• Mucinous Breast Cancer
• Tubular Breast Cancer

Intervention

Drug:
• Paclitaxel

• Cisplatin

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai Jiaotong University School of Medicine, Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response of breast and lymph nodes		after 4 months preoperative treatment
Secondary	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	4 months during neoadjuvant therapy
Secondary	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	4 months during treatment
Secondary	regional recurrence free survival (RRFS)	RRFS is defined as the time period between registration and first event	5 years
Secondary	local recurrence free survival (LRFS)	LRFS is defined as the time period between registration and first event	5 years
Secondary	distant-disease- free survival (DDFS)	DFS is defined as the time period between registration and first event	5 years
Secondary	overall survival (OS)	OS is defined as the time period between registration and first event	5 years