Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast Cancer (NATT)

November 19, 2016 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

A Multi-Center, Randomized Study of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Neoadjuvant Treatment of Triple-Negative or Her2 Positive Breast Cancer

The purpose of this study is to compare the pathological complete response (pCR) rate in triple-negative or Her2 positive breast cancer patients treated with neoadjuvant docetaxel, anthracycline and cyclophosphamide (TAC) or docetaxel and cyclophosphamide (TC) regimen.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the leading cause of cancer in women in China. Neoadjuvant chemotherapy for treatment of locally advanced breast cancer has become a standard therapy. Results from neoadjuvant trials have shown that pathological complete response (pCR) is an independent predictor of outcome. Docetaxel was introduced into clinical practice in the early 1990s and has demonstrated good activity in the adjuvant and metastatic settings. Both TC and TAC are effective regimens in the adjuvant setting. The most optimal regimen in the neoadjuvant treatment is however unknown. This is especially true in triple-negative or HER2 positive breast cancer. This study will evaluate the pCR rate of TAC and TC as neoadjuvant treatment for triple-negative or HER2 positive breast cancer.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

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
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • The First People's Hospital of Foshan
      • Guangzhou, Guangdong, China, 510010
        • Guangdong Provincial Maternal and Child Health Hospital
      • Guangzhou, Guangdong, China, 510010
        • Guangzhou General Hospital of Guangzhou Military Area
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
      • Changsha, Hunan, China, 410009
        • Hunan Cancer Hospital
    • Jiangsu
      • Jiangyin, Jiangsu, China, 214440
        • Jiangyin People's Hospital
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
      • Suzhou, Jiangsu, China, 215004
        • The Second Affilliated Hospital of Suzhou University
      • Wujiang, Jiangsu, China, 215200
        • Wujiang First People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330009
        • The Third Hospital of Nanchang
    • Shandong
      • Linyi, Shandong, China, 276003
        • Linyi People's Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital
      • Shanghai, Shanghai, China, 200021
        • Shanghai Obstetrics and Gynecology Hospital
      • Shanghai, Shanghai, China, 200033
        • The International Peace Maternity and Child Health Hospital
      • Shanghai, Shanghai, China, 200092
        • Xin Hua Hospital, Shanghai Jiaotong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincical Cancer Hospital
      • Xi'an, Shanxi, China, 710061
        • Fisrt Affiliated Hospital of Medical College of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital Sichuan University
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Sinkiang Uygur Autonomous Region Cancer Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650106
        • Yunnan Provincical Tumor Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Obstetrics and Gynecology Hospital affiliated to Zhejiang University
      • Hangzhou, Zhejiang, China, 310006
        • Zhejiang Traditional Chinese Medical Hospital
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First People's Hospital
      • Taizhou, Zhejiang, China, 318050
        • Taizhou Hospital of Zhejiang Province
      • Wenzhou, Zhejiang, China, 325000
        • The First Affilliated Hospital of Wenzhou Medical College
      • Wenzhou, Zhejiang, China, 325208
        • Ruian People's 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:

  • Women aged ≥ 18 years and < 70 years
  • Karnofsky performance status (KPS) ≥ 70
  • At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), T2N1 or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3)
  • Biopsy specimens are available for ER, PgR and Her2 detection, patients should be with triple negative or Her2 positive breast cancer, Her2 positivity is defined as FISH/CISH Her2 positive or IHC Her2 3+, Triple-negative disease defined as negativity for ER, PgR and Her2
  • Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L
  • An estimated life expectancy of at least 12 months
  • Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
  • Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
  • Written informed consent according to the GCP

Exclusion Criteria:

  • Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
  • Metastatic breast cancer
  • With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
  • Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
  • inadequate liver function (bilirubin > 1.0 times upper normal limit [UNL] and ALT and/or AST> 1.5 UNL associated with alkaline phosphatase > 2.5 UNL; inadequate renal function (creatinine > 1.0 times UNL and in case of limit value, Creatinine clearance < 60 ml/min)
  • Contraindication for using dexamethasone
  • History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)
  • Has peripheral neuropathy ≥ grade 1
  • Patient is pregnant or breast feeding
  • Known severe hypersensitivity to any drugs in this study
  • Treatment with any investigational drugs within 30 days before the beginning of study treatment

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TAC Arm
six cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide
Drug: Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 every 3 weeks for six cycles
EXPERIMENTAL: TC Arm
six cycles of neoadjuvant Docetaxel and Cyclophosphamide
Drug: Docetaxel, cyclophosphamide
Docetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pathological complete remission (pCR) rate
Time Frame: after 6 cycles of neoadjuvant therapy
after 6 cycles of neoadjuvant therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
disease free survival (DFS) and overall survival (OS)
Time Frame: 5-year
5-year
clinical response rate
Time Frame: after 6 cycles of neoadjuvant therapy
after 6 cycles of neoadjuvant therapy
safety profile
Time Frame: during neoadjuvant therapy
during neoadjuvant therapy
breast conservation therapy (BCT) rate
Time Frame: after surgery
after surgery

Collaborators and Investigators

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

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

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

Helpful Links

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

July 1, 2009

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (ESTIMATE)

June 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 19, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NATT

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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