Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer (SHPD001)

Shanghai Jiao Tong University

Status and phase: Completed; Phase 2

Conditions: Invasive Ductal Breast Cancer; Inflammatory Breast Cancer; Tubular Breast Cancer; Mucinous Breast Cancer

Treatments: Drug: Paclitaxel; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02199418

RenJiH-BC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

Paclitaxel and Cisplatin

Experimental group

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

Treatment:

Drug: Cisplatin

Drug: Paclitaxel