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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)

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ClinicalTrials.gov 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
Sponsor:
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 ]


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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00912444


Locations
Show Show 27 study locations
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Kunwei Shen Shanghai Jiao Tong University School of Medicine
Additional Information:
Publications:
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Responsible Party: Kunwei Shen, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT00912444    
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
Neoadjuvant
Chemotherapy
Docetaxel
Cyclophosphamide
Anthracycline
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Epirubicin
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