Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 3

Conditions: Invasive Duct Carcinoma of Breast; Tubular Breast Cancer; Mucinous Breast Cancer

Treatments: Drug: Paclitaxel, Cisplatin; Drug: EC to docetaxel or paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03201861

SHPD004

Details and patient eligibility

About

The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .

Full description

In this trial, patients will be randomly assigned in a 2:1 ratio to receive cisplatin-based adjuvant chemotherapy and to standard adjuvant chemotherapy.

Enrollment: 762 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged ≥18 years and ≤70 years
2. Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma
3. Not received treatment for breast cancer before operation
4. Triple-negative breast cancer confirmed by pathology, or pathology confirmed as the HR positive breast cancer at the same time meet the following conditions: axillary lymph node positive breast cancer, tumor size≥2 cm and Ki - 67 >20% or tumor size ≥2 cm and grade III or tumor size ≥2cm and aged <35 years
5. HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified
6. Performance status (PS) 0-1
7. 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 , creatinine≤1.5 upper normal limit, bilirubin≤1.5 upper normal limit
8. No obvious main organs dysfunction

Exclusion criteria

1. metastatic breast cancer
2. Patient is pregnant or breast feeding
3. Any evidence of sense or motor nerve disorders
4. Bilateral Primary Breast Cancer (DCIS in one side not included)
5. Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection
6. Have received chemotherapy because of any malignancy other than breast cancer
7. Known severe hypersensitivity to any drugs in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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762 participants in 2 patient groups

paclitaxel and cisplatin

Experimental group

Description:

Drug: paclitaxel, cisplatin, epirubicin and cyclophosphamide Patients will be administered paclitaxel (80 mg/m² i.v. given weekly on day 1 q day 8 for 12 weeks) and cisplatin (25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 3 cycles) followed by epirubicin and cyclophosphamide (EC) (epirubicin 90mg/m² i.v.d1, cyclophosphamide 600mg/m² i.v.d1) for 4 cycles.

Treatment:

Drug: Paclitaxel, Cisplatin

epirubicin and cyclophosphamide

Active Comparator group

Description:

Drug：epirubicin, cyclophosphamide, paclitaxel and docetaxel Investigators will declare one of the following regimens: Patients with hormone receptor (HR) positive breast cancer wil be administered epirubicin (90mg/m² i.v.d1 q21d) and cyclophosphamide (600mg/m² i.v.d1 q21d) for 4 cycles followed by docetaxel (75mg/m² i.v.d1 q21d) for 4 cycles. Patients with triple-negative breast cancer will be administered epirubicin (90mg/m² i.v.d1 q21d) and cyclophosphamide (600mg/m² i.v.d1 q21d) for 4 cycles followed by weekly paclitaxel (80 mg/m² i.v.d1) for 12 weeks or docetaxel (75mg/m² i.v.d1 q21d) for 4 cycles.

Treatment:

Drug: EC to docetaxel or paclitaxel