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

Phase 3

Recruiting

• Conditions: Tubular Breast Cancer; Mucinous Breast Cancer; Invasive Duct Carcinoma of Breast
• Interventions: Drug: Paclitaxel, Cisplatin; Drug: EC to docetaxel or paclitaxel

• Registration Number: NCT03201861
• Lead Sponsor: RenJi Hospital

Brief Summary

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 .

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-25
• Study First Posted: 2017-06-28
• Study Start: 2017-07-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-08-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 762

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paclitaxel and cisplatin	Paclitaxel, Cisplatin	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.
epirubicin and cyclophosphamide	EC to docetaxel or paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Disease-Free Survival (DFS) Events	up to 5 year follow up	DFS is defined as the time period between registration and first event

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.	5 months during adjuvant therapy	Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped
Number of Participants With Overall Survival (OS) Events	up to 5 year follow up	OS is defined as the time period between registration and first event

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China