Back to resultsWeekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients (SHPD002)
Primary Purpose
Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Ductal Breast Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
Cisplatin
Gonadotropin-releasing hormone agonist
Letrozole
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 N0-3M0;
- ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as >1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals >2.0 or HER2 gene copy >6.0.
- No prior systemic or loco-regional treatment of breast cancer;
- 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
- Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital
- HanDan Central Hospital
- The First Affiliated Hospital of University of South China
- Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage
- The second people's hospital of Kunshan city
- Department of Medical Oncology, General Hospital of Ningxia Medical University
- Zhongshan Hospital
- Shanghai Jiaotong University School of Medicine, Renji Hospital
- Yueyang hospital of integrated traditional Chinese and Western medine
- Armed Police Corps Hospital of Shanghai
- Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University
- Zhoushan hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Chemotherapy only
GnRHa
letrozole
Arm Description
Paclitaxel injection 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle；Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle； for 4 cycles
Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Gonadotropin-releasing hormone agonist （GnRHa）11.25 mg every 3 months or 3.6mg every month subcutaneously
Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Letrozole 2.5mg/day
Outcomes
Primary Outcome Measures
pathological complete remission rate
Pathological complete remission is defined as no invasive cancer in breast and axillary nodes.
Secondary Outcome Measures
Number of Participants With Drug Related Treatment Adverse Events
Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.
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
disease free survival (DFS)
DFS is defined as the time in months from randomization until first occurrence of locoregional recurrence, distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause.
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
overall survival (OS)
OS is defined as the time period between registration and first event
distant-disease- free survival (DDFS)
DDFS is defined as the time period between registration and first event
rate of tumor remission （RTR）
RTR is defined as the proportion of tumor remission per unit time
serum markers
Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery
molecular markers
Pre-treatment and surgical expression of molecular markers （LHRHa receptor, EGFR，PD-L1)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02221999
Brief Title
Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
Acronym
SHPD002
Official Title
A Prospective, Randomized, Open-label Comparison of Preoperative Weekly Paclitaxel and Cisplatin With or Without Endocrine Therapy in Patients With Operable Hormone Receptor Positive and Triple Negative Locally Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2013 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2029 (Anticipated)
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 hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.
In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate.
Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.
Detailed Description
In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. Letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. Patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. Postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy.
Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.
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, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy only
Arm Type
Active Comparator
Arm Description
Paclitaxel injection 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle；Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle； for 4 cycles
Arm Title
GnRHa
Arm Type
Experimental
Arm Description
Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Gonadotropin-releasing hormone agonist （GnRHa）11.25 mg every 3 months or 3.6mg every month subcutaneously
Arm Title
letrozole
Arm Type
Experimental
Arm Description
Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Letrozole 2.5mg/day
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Gonadotropin-releasing hormone agonist
Intervention Description
Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m
Intervention Type
Drug
Intervention Name(s)
Letrozole
Primary Outcome Measure Information:
Title
pathological complete remission rate
Description
Pathological complete remission is defined as no invasive cancer in breast and axillary nodes.
Time Frame
after 4 months preoperative treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Drug Related Treatment Adverse Events
Description
Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.
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
disease free survival (DFS)
Description
DFS is defined as the time in months from randomization until first occurrence of locoregional recurrence, distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause.
Time Frame
5 years
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
overall survival (OS)
Description
OS is defined as the time period between registration and first event
Time Frame
5 years
Title
distant-disease- free survival (DDFS)
Description
DDFS is defined as the time period between registration and first event
Time Frame
5 years
Title
rate of tumor remission （RTR）
Description
RTR is defined as the proportion of tumor remission per unit time
Time Frame
after 2 cycles and 4 cycles during neoadjuvant therapy
Title
serum markers
Description
Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery
Time Frame
Pre-treatment and/or surgical
Title
molecular markers
Description
Pre-treatment and surgical expression of molecular markers （LHRHa receptor, EGFR，PD-L1)
Time Frame
Pre-treatment and/or surgical
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 N0-3M0;
ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as >1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals >2.0 or HER2 gene copy >6.0.
No prior systemic or loco-regional treatment of breast cancer;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsong Lu
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
HanDan Central Hospital
City
Handan
State/Province
Hebei
ZIP/Postal Code
056001
Country
China
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage
City
Hohhot
State/Province
Inner Mongolia
Country
China
Facility Name
The second people's hospital of Kunshan city
City
Kunshan
State/Province
Jiangsu
ZIP/Postal Code
215300
Country
China
Facility Name
Department of Medical Oncology, General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
Zhongshan Hospital
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
Facility Name
Yueyang hospital of integrated traditional Chinese and Western medine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200437
Country
China
Facility Name
Armed Police Corps Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201103
Country
China
Facility Name
Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhoushan hospital
City
Zhoushan
State/Province
Zhejiang
ZIP/Postal Code
316021
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
31488093
Citation
Bayarmaa B, Wu Z, Peng J, Wang Y, Xu S, Yan T, Yin W, Lu J, Zhou L. Association of LncRNA MEG3 polymorphisms with efficacy of neoadjuvant chemotherapy in breast cancer. BMC Cancer. 2019 Sep 5;19(1):877. doi: 10.1186/s12885-019-6077-3.
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
Learn more about this trial
Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
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