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

January 23, 2017 updated by: Jinsong Lu, RenJi Hospital

Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai, China, 200127
        • shanghai Jiaotong University School of Medicine, Renji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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: Cisplatin
Drug: Paclitaxel
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological complete response of breast and lymph nodes
Time Frame: after 4 months preoperative treatment
after 4 months preoperative treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months during neoadjuvant therapy
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
4 months during treatment
regional recurrence free survival (RRFS)
Time Frame: 5 years
RRFS is defined as the time period between registration and first event
5 years
local recurrence free survival (LRFS)
Time Frame: 5 years
LRFS is defined as the time period between registration and first event
5 years
distant-disease- free survival (DDFS)
Time Frame: 5 years
DFS is defined as the time period between registration and first event
5 years
overall survival (OS)
Time Frame: 5 years
OS is defined as the time period between registration and first event
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (ESTIMATE)

July 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-BC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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