Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer (SHPD001)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by RenJi Hospital
Sponsor:
Information provided by (Responsible Party):
Jinsong Lu, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT02199418
First received: July 14, 2014
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Tubular Breast Cancer
Mucinous Breast Cancer
Invasive Ductal Breast Cancer
Inflammatory Breast Cancer
Drug: Paclitaxel
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by RenJi Hospital:

Primary Outcome Measures:
  • Pathological complete response of breast and lymph nodes [ Time Frame: after 4 months preoperative treatment ] [ Designated as safety issue: No ]

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

  • Clinical and imaging response [ Time Frame: 4 months during treatment ] [ Designated as safety issue: No ]
    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

  • regional recurrence free survival (RRFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    RRFS is defined as the time period between registration and first event

  • local recurrence free survival (LRFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    LRFS is defined as the time period between registration and first event

  • distant-disease- free survival (DDFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    DFS is defined as the time period between registration and first event

  • overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    OS is defined as the time period between registration and first event


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 epidermalgrowth 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 Drug: Cisplatin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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, T2-3 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02199418

Contacts
Contact: Jinsong Lu lujjss@163.com

Locations
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jinsong Lu, MD         
Contact: Zhimin Shao, MD         
Shanghai Jiaotong University School of Medicine, Renji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: Jinsong Lu, MD       lujjss@163.com   
Sponsors and Collaborators
RenJi Hospital
  More Information

No publications provided

Responsible Party: Jinsong Lu, Director of Breast Surgery, RenJi Hospital
ClinicalTrials.gov Identifier: NCT02199418     History of Changes
Other Study ID Numbers: RenJiH-BC-001
Study First Received: July 14, 2014
Last Updated: July 23, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal, Breast
Inflammatory Breast Neoplasms
Adenocarcinoma
Breast Diseases
Carcinoma
Carcinoma, Ductal
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases
Cisplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014