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Trial record 1 of 1 for:    NCT02199418
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Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer (SHPD001)

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. Read our disclaimer for details. Identifier: NCT02199418
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
Jinsong Lu, RenJi Hospital

Brief Summary:
The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.

Condition or disease Intervention/treatment Phase
Tubular Breast Cancer Mucinous Breast Cancer Invasive Ductal Breast Cancer Inflammatory Breast Cancer Drug: Paclitaxel Drug: Cisplatin Phase 2

Detailed Description:
In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
Study Start Date : January 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Paclitaxel and Cisplatin

Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.

Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year

Drug: Paclitaxel
Other Name: Taxol

Drug: Cisplatin

Primary Outcome Measures :
  1. Pathological complete response of breast and lymph nodes [ Time Frame: after 4 months preoperative treatment ]

Secondary Outcome Measures :
  1. Tolerability and Safety [ Time Frame: 4 months during neoadjuvant therapy ]
    Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped

  2. Clinical and imaging response [ Time Frame: 4 months during treatment ]
    To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment

  3. regional recurrence free survival (RRFS) [ Time Frame: 5 years ]
    RRFS is defined as the time period between registration and first event

  4. local recurrence free survival (LRFS) [ Time Frame: 5 years ]
    LRFS is defined as the time period between registration and first event

  5. distant-disease- free survival (DDFS) [ Time Frame: 5 years ]
    DFS is defined as the time period between registration and first event

  6. overall survival (OS) [ Time Frame: 5 years ]
    OS is defined as the time period between registration and first event

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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

Inclusion Criteria:

  1. Women aged ≥18years and ≤70 years
  2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-2M0
  3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as >1% stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH ratio ≥ 2.0
  4. No prior systemic or loco-regional treatment of breast cancer
  5. ECOG 0-2
  6. 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 (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL
  7. No obvious main organs dysfunction

Exclusion Criteria:

  1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug
  2. Patient is pregnant or breast feeding
  3. Inflammatory breast cancer and metastatic breast cancer
  4. Any evidence of sense or motor nerve disorders
  5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection
  6. Any concurrent malignancy other than breast cancer
  7. Know 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 identifier (NCT number): NCT02199418

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China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
RenJi Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jinsong Lu, Director of Breast Surgery, RenJi Hospital Identifier: NCT02199418     History of Changes
Other Study ID Numbers: RenJiH-BC-001
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Inflammatory Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action