Overview

This trial is active, not recruiting.

Conditions tubular breast cancer, mucinous breast cancer, invasive ductal breast cancer, inflammatory breast cancer
Treatments paclitaxel, cisplatin
Phase phase 2
Sponsor RenJi Hospital
Start date January 2013
End date November 2015
Trial size 132 participants
Trial identifier NCT02199418, RenJiH-BC-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 epidermalgrowth 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
paclitaxel
cisplatin

Primary Outcomes

Measure
Pathological complete response of breast and lymph nodes
time frame: after 4 months preoperative treatment

Secondary Outcomes

Measure
Tolerability and Safety
time frame: 4 months during neoadjuvant therapy
Clinical and imaging response
time frame: 4 months during treatment
regional recurrence free survival (RRFS)
time frame: 5 years
local recurrence free survival (LRFS)
time frame: 5 years
distant-disease- free survival (DDFS)
time frame: 5 years
overall survival (OS)
time frame: 5 years

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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

Additional Information

Official title Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by RenJi Hospital.