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

This study has been terminated.
(TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.)
Sponsor:
Information provided by (Responsible Party):
Kunwei Shen, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00912444
First received: June 1, 2009
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • pathological complete remission (pCR) rate [ Time Frame: after 6 cycles of neoadjuvant therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease free survival (DFS) and overall survival (OS) [ Time Frame: 5-year ] [ Designated as safety issue: No ]
  • clinical response rate [ Time Frame: after 6 cycles of neoadjuvant therapy ] [ Designated as safety issue: No ]
  • safety profile [ Time Frame: during neoadjuvant therapy ] [ Designated as safety issue: Yes ]
  • breast conservation therapy (BCT) rate [ Time Frame: after surgery ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: July 2009
Estimated Study Completion Date: December 2016
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  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: NCT00912444

Locations
China, Guangdong
The First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
Guangzhou General Hospital of Guangzhou Military Area
Guangzhou, Guangdong, China, 510010
Guangdong Provincial Maternal and Child Health Hospital
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
Ruijin Hospital
Shanghai, Shanghai, China, 200025
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
Shanghai Obstetrics and Gynecology Hospital
Shanghai, Shanghai, China, 200021
Xin Hua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200092
the International Peace Maternity and Child health Hospital
Shanghai, Shanghai, China, 200033
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
Zhejiang Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, China, 310006
Obstetrics and Gynecology Hospital affiliated to Zhejiang University
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
Investigators
Principal Investigator: Kunwei Shen Shanghai Jiao Tong University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Kunwei Shen, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT00912444     History of Changes
Other Study ID Numbers: NATT
Study First Received: June 1, 2009
Last Updated: July 25, 2014
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Breast Neoplasms
Neoadjuvant
Chemotherapy
Docetaxel
Cyclophosphamide
Anthracycline

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Liposomal doxorubicin
Cyclophosphamide
Epirubicin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014