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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201861
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
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 .

Condition or disease Intervention/treatment Phase
Tubular Breast Cancer Mucinous Breast Cancer Invasive Duct Carcinoma of Breast Drug: Paclitaxel, Cisplatin Drug: EC to docetaxel or paclitaxel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 762 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 27, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: paclitaxel and 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.
Drug: Paclitaxel, Cisplatin
weekly paclitaxel and cisplatin
Other Name: Taxol

Active Comparator: epirubicin and cyclophosphamide

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.

Drug: EC to docetaxel or paclitaxel
Standard adjuvant chemotherapy recommended by guideline
Other Name: Taxol




Primary Outcome Measures :
  1. Number of Participants With Disease-Free Survival (DFS) Events [ Time Frame: up to 5 year follow up ]
    DFS is defined as the time period between registration and first event


Secondary Outcome Measures :
  1. Number of Participants With Overall Survival (OS) Events [ Time Frame: up to 5 year follow up ]
    OS is defined as the time period between registration and first event

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v3.0. [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201861


Contacts
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Contact: Yueyao Du, M.D. 86-21-68385569 jessicayy8629@126.com
Contact: Jie Zhang, M.D. 86-21-68385516 doudou090227@163.com

Locations
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China, Shanghai
Renji Hospital, School of Medicine, Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Yueyao Du, M.D.    86-21-68385569    jessicayy8629@126.com   
Contact: Jie Zhang, M.D.    86-21-68385516    doudou090227@163.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Jinsong Lu, M.D. Shanghai Jiao Tong University School of Medicine
Publications:
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03201861    
Other Study ID Numbers: SHPD004
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action