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

Arm | Intervention/treatment |
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Experimental: TAC Arm
six cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide
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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
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Drug: Docetaxel, cyclophosphamide
Docetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles |
- pathological complete remission (pCR) rate [ Time Frame: after 6 cycles of neoadjuvant therapy ]
- disease free survival (DFS) and overall survival (OS) [ Time Frame: 5-year ]
- clinical response rate [ Time Frame: after 6 cycles of neoadjuvant therapy ]
- safety profile [ Time Frame: during neoadjuvant therapy ]
- 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 |
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

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

Principal Investigator: | Kunwei Shen | Shanghai Jiao Tong University School of Medicine |
Publications:
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 |
Breast Neoplasms Neoadjuvant Chemotherapy |
Docetaxel Cyclophosphamide Anthracycline |
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 |