Clinical trial NCT02199418: Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer
Official title: Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tubular Breast Cancer
Mucinous Breast Cancer
Invasive Ductal Breast Cancer
Inflammatory Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pathological complete response of breast and lymph nodes
timeFrame: after 4 months preoperative treatment
Secondary outcomes:
measure: Tolerability and Safety
timeFrame: 4 months during neoadjuvant therapy
measure: Clinical and imaging response
timeFrame: 4 months during treatment
measure: regional recurrence free survival (RRFS)
timeFrame: 5 years
measure: local recurrence free survival (LRFS)
timeFrame: 5 years
measure: distant-disease- free survival (DDFS)
timeFrame: 5 years
measure: overall survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine, Renji Hospital
state: Shanghai
Study officials:
References:
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.
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.