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

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: NCT00912444
Recruitment Status : Terminated (TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.)
First Posted : June 3, 2009
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):
Kunwei Shen, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide Drug: Docetaxel, cyclophosphamide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. pathological complete remission (pCR) rate [ Time Frame: after 6 cycles of neoadjuvant therapy ]

Secondary Outcome Measures :
  1. disease free survival (DFS) and overall survival (OS) [ Time Frame: 5-year ]
  2. clinical response rate [ Time Frame: after 6 cycles of neoadjuvant therapy ]
  3. safety profile [ Time Frame: during neoadjuvant therapy ]
  4. breast conservation therapy (BCT) rate [ Time Frame: after surgery ]

Information from the National Library of Medicine

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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:

  • 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

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): NCT00912444

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

Additional Information:
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Responsible Party: Kunwei Shen, Professor, Shanghai Jiao Tong University School of Medicine Identifier: NCT00912444     History of Changes
Other Study ID Numbers: NATT
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Keywords provided by Kunwei Shen, Shanghai Jiao Tong University School of Medicine:
Breast Neoplasms
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors