Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer
SHPD001
Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
1 other identifier
interventional
132
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2013
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJanuary 25, 2017
January 1, 2017
2.8 years
July 14, 2014
January 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pathological complete response of breast and lymph nodes
after 4 months preoperative treatment
Secondary Outcomes (6)
Tolerability and Safety
4 months during neoadjuvant therapy
Clinical and imaging response
4 months during treatment
regional recurrence free survival (RRFS)
5 years
local recurrence free survival (LRFS)
5 years
distant-disease- free survival (DDFS)
5 years
- +1 more secondary outcomes
Study Arms (1)
Paclitaxel and Cisplatin
EXPERIMENTALPaclitaxel: 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (2)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200127, China
Related Publications (3)
Wan C, Zhou L, Jin Y, Li F, Wang L, Yin W, Wang Y, Li H, Jiang L, Lu J. Strain ultrasonic elastography imaging features of locally advanced breast cancer: association with response to neoadjuvant chemotherapy and recurrence-free survival. BMC Med Imaging. 2023 Dec 21;23(1):216. doi: 10.1186/s12880-023-01168-2.
PMID: 38129778DERIVEDSun 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.
PMID: 33154826DERIVEDWu 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.
PMID: 30976202DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Breast Surgery
Study Record Dates
First Submitted
July 14, 2014
First Posted
July 24, 2014
Study Start
January 1, 2013
Primary Completion
November 1, 2015
Study Completion
October 1, 2016
Last Updated
January 25, 2017
Record last verified: 2017-01