Clinical trial NCT03201861: Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women
Official title: Phase 3 Study of Weekly Paclitaxel in Combination With Cisplatin as Adjuvant Chemotherapy for Early Stage Human Epidermal Growth Factor Receptor-2 (HER2) Negative Breast Cancer in High-risk Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Tubular Breast Cancer
Mucinous Breast Cancer
Invasive Duct Carcinoma of Breast
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 762
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Disease-Free Survival (DFS) Events
timeFrame: up to 5 year follow up
Secondary outcomes:
measure: Number of Participants With Overall Survival (OS) Events
timeFrame: up to 5 year follow up
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.
timeFrame: 5 months during adjuvant therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jinsong Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sparano JA, Zhao F, Martino S, Ligibel JA, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE. Long-Term Follow-Up of the E1199 Phase III Trial Evaluating the Role of Taxane and Schedule in Operable Breast Cancer. J Clin Oncol. 2015 Jul 20;33(21):2353-60. doi: 10.1200/JCO.2015.60.9271. Epub 2015 Jun 15.