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Recruiting NCT03201861

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

Phase III Interventional Tubular Breast Cancer Mucinous Breast Cancer Invasive Duct Carcinoma of Breast

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Paclitaxel, Cisplatin, EC to docetaxel or paclitaxel.
Who it may be relevant to
Registry conditions: Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Duct Carcinoma of Breast. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Paclitaxel, Cisplatin
    weekly paclitaxel and cisplatin
  • Drug EC to docetaxel or paclitaxel
    Standard adjuvant chemotherapy recommended by guideline

Primary outcome measures

  • Number of Participants With Disease-Free Survival (DFS) Events [Time frame: up to 5 year follow up]
Secondary outcome measures (2)
  • Number of Participants With Overall Survival (OS) Events [Time frame: up to 5 year follow up]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v3.0. [Time frame: 5 months during adjuvant therapy]

Eligibility criteria

Inclusion criteria

  • Women aged ≥18 years and ≤70 years
  • Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma
  • Not received treatment for breast cancer before operation
  • 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
  • HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified
  • Performance status (PS) 0-1
  • 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
  • No obvious main organs dysfunction

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai

Publications

  • 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. PMID 26077235

Identifiers

NCT: NCT03201861 · SHPD004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗