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:
Shanghai Jiao Tong University School of Medicine
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
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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
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 | |
| Guangdong Provincial Maternal and Child Health Hospital | |
| Guangzhou, Guangdong, China, 510010 | |
| Guangzhou General Hospital of Guangzhou Military Area | |
| Guangzhou, Guangdong, China, 510010 | |
| China, Hunan | |
| Hunan Cancer Hospital | |
| Changsha, Hunan, China, 410009 | |
| Xiangya Hospital Central South University | |
| Changsha, Hunan, China, 410008 | |
| 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 | |
| Shanghai Obstetrics and Gynecology Hospital | |
| Shanghai, Shanghai, China, 200021 | |
| 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 | |
| Zhongshan Hospital Fudan University | |
| Shanghai, Shanghai, China, 200032 | |
| 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 | |
| Ruian People's Hospital | |
| Wenzhou, Zhejiang, China, 325208 | |
| The First Affilliated Hospital of Wenzhou Medical College | |
| Wenzhou, Zhejiang, China, 325000 | |
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:
|
Cyclophosphamide Docetaxel Alkylating Agents Antimitotic Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Immunologic Factors |
Immunosuppressive Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on March 03, 2015