Back to resultsAddition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer (SHPD001)
Primary Purpose
Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Ductal Breast Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Tubular Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Fudan University Shanghai Cancer Center
- Shanghai Jiaotong University School of Medicine, Renji Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paclitaxel and Cisplatin
Arm Description
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
Outcomes
Primary Outcome Measures
Pathological complete response of breast and lymph nodes
Secondary Outcome Measures
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
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
regional recurrence free survival (RRFS)
RRFS is defined as the time period between registration and first event
local recurrence free survival (LRFS)
LRFS is defined as the time period between registration and first event
distant-disease- free survival (DDFS)
DFS is defined as the time period between registration and first event
overall survival (OS)
OS is defined as the time period between registration and first event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02199418
Brief Title
Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer
Acronym
SHPD001
Official Title
Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Ductal Breast Cancer, Inflammatory Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel and Cisplatin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Primary Outcome Measure Information:
Title
Pathological complete response of breast and lymph nodes
Time Frame
after 4 months preoperative treatment
Secondary Outcome Measure Information:
Title
Tolerability and Safety
Description
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
Title
Clinical and imaging response
Description
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
Title
regional recurrence free survival (RRFS)
Description
RRFS is defined as the time period between registration and first event
Time Frame
5 years
Title
local recurrence free survival (LRFS)
Description
LRFS is defined as the time period between registration and first event
Time Frame
5 years
Title
distant-disease- free survival (DDFS)
Description
DFS is defined as the time period between registration and first event
Time Frame
5 years
Title
overall survival (OS)
Description
OS is defined as the time period between registration and first event
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Jiaotong University School of Medicine, Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
33154826
Citation
Sun L, Yin W, Wu Z, Wang Y, Lu J. The Predictive Value of Pre-therapeutic Serum Gamma-glutamyl transferase in Efficacy and Adverse Reactions to Neoadjuvant Chemotherapy among Breast Cancer Patients. J Breast Cancer. 2020 Oct;23(5):509-520. doi: 10.4048/jbc.2020.23.e59.
Results Reference
derived
PubMed Identifier
30976202
Citation
Wu Z, Zhang L, Xu S, Lin Y, Yin W, Lu J, Sha R, Sheng X, Zhou L, Lu J. Predictive and prognostic value of ZEB1 protein expression in breast cancer patients with neoadjuvant chemotherapy. Cancer Cell Int. 2019 Mar 29;19:78. doi: 10.1186/s12935-019-0793-2. eCollection 2019.
Results Reference
derived
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Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer
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