Breast CancerPhase 3NATTNCT00912444
Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast Cancer
A Phase 3 study testing Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide and Docetaxel, cyclophosphamide in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 27 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide and Docetaxel, cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 27 sitesChina
- Study dates
- Jul 2009to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
China27 sites
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Hunan Cancer Hospital
Changsha, Hunan, 410009
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Guangdong Provincial Maternal and Child Health Hospital
Guangzhou, Guangdong, 510010
Guangzhou General Hospital of Guangzhou Military Area
Guangzhou, Guangdong, 510010
Obstetrics and Gynecology Hospital affiliated to Zhejiang University
Hangzhou, Zhejiang, 310006
Zhejiang Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, 310006
Jiangyin People's Hospital
Jiangyin, Jiangsu, 214440
Yunnan Provincical Tumor Hospital
Kunming, Yunnan, 650106
Linyi People's Hospital
Linyi, Shandong, 276003
The third hospital of Nanchang
Nanchang, Jiangxi, 330009
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Ningbo First People's Hospital
Ningbo, Zhejiang, 315010
Shanghai Obstetrics and Gynecology Hospital
Shanghai, Shanghai Municipality, 200021
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
the International Peace Maternity and Child health Hospital
Shanghai, Shanghai Municipality, 200033
Xin Hua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
The Second Affilliated Hospital of Suzhou University
Suzhou, Jiangsu, 215004
Shanxi Provincical Cancer Hospital
Taiyuan, Shanxi, 030013
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 318050
Sinkiang Uygur Autonomous Region Cancer Hospital
Ürümqi, Xinjiang, 830000
The First Affilliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
Ruian People's Hospital
Wenzhou, Zhejiang, 325208
Wujiang First People's Hospital
Wujiang, Jiangsu, 215200
Fisrt Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide, Docetaxel, cyclophosphamide
- Keywords
- Breast Neoplasms, Neoadjuvant, Chemotherapy, Docetaxel, Cyclophosphamide, Anthracycline
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, Anthracycline (Doxorubicin or Epirubicin), CyclophosphamideDrug
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 every 3 weeks for six cycles
Docetaxel, cyclophosphamideDrug
Docetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles
| Study group | Role | What they receive |
|---|---|---|
| TAC Arm | Experimental | six cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide Receives: Drug: Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide |
| TC Arm | Experimental | six cycles of neoadjuvant Docetaxel and Cyclophosphamide Receives: Drug: Docetaxel, cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete remission (pCR) rate
Measured: after 6 cycles of neoadjuvant therapy
Secondary outcomes (4)
disease free survival (DFS) and overall survival (OS)
Measured: 5-year
clinical response rate
Measured: after 6 cycles of neoadjuvant therapy
safety profile
Measured: during neoadjuvant therapy
breast conservation therapy (BCT) rate
Measured: after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2012
- Study completionOct 2015
Why it stopped: TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kunwei Shen, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912444
- Sponsor's protocol ID
- NATT
- Acronym
- NATT
- Status last verified
- Nov 2016
- First submitted
- 1 Jun 2009
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang L, Li LD, Chen YD, Parkin DM. [Time trends, estimates and projects for breast cancer incidence and mortality in China]. Zhonghua Zhong Liu Za Zhi. 2006 Jun;28(6):438-40. Chinese.
PubMed 17152490Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, Sandbach J, Hyman WJ, Khandelwal P, Negron AG, Richards DA, Anthony SP, Mennel RG, Boehm KA, Meyer WG, Asmar L. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006 Dec 1;24(34):5381-7. doi: 10.1200/JCO.2006.06.5391.
PubMed 17135639Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681.
PubMed 15930421Rouzier R, Perou CM, Symmans WF, Ibrahim N, Cristofanilli M, Anderson K, Hess KR, Stec J, Ayers M, Wagner P, Morandi P, Fan C, Rabiul I, Ross JS, Hortobagyi GN, Pusztai L. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res. 2005 Aug 15;11(16):5678-85. doi: 10.1158/1078-0432.CCR-04-2421.
PubMed 16115903
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00912444
- Acronym / sponsor ID
- NATT / NATT
- Conditions
- Breast Cancer
- Keywords
- Breast Neoplasms, Neoadjuvant, Chemotherapy, Docetaxel, Cyclophosphamide, Anthracycline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAC Arm | Experimental | Drug: Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamidesix cycles of neoadjuvant Docetaxel, Anthracycline and Cyclophosphamide |
| TC Arm | Experimental | Drug: Docetaxel, cyclophosphamidesix cycles of neoadjuvant Docetaxel and Cyclophosphamide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel, Anthracycline (Doxorubicin or Epirubicin), CyclophosphamideDocetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 every 3 weeks for six cycles | Drug | TAC Arm |
| Docetaxel, cyclophosphamideDocetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles | Drug | TC Arm |
Primary outcome
pathological complete remission (pCR) rate
Time frame: after 6 cycles of neoadjuvant therapy
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Background: PubMed 17152490Yang L, Li LD, Chen YD, Parkin DM. [Time trends, estimates and projects for breast cancer incidence and mortality in China]. Zhonghua Zhong Liu Za Zhi. 2006 Jun;28(6):438-40. Chinese.
- Background: PubMed 17135639Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, Sandbach J, Hyman WJ, Khandelwal P, Negron AG, Richards DA, Anthony SP, Mennel RG, Boehm KA, Meyer WG, Asmar L. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006 Dec 1;24(34):5381-7. doi: 10.1200/JCO.2006.06.5391.
- Background: PubMed 15930421Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681.
- Background: PubMed 16115903Rouzier R, Perou CM, Symmans WF, Ibrahim N, Cristofanilli M, Anderson K, Hess KR, Stec J, Ayers M, Wagner P, Morandi P, Fan C, Rabiul I, Ross JS, Hortobagyi GN, Pusztai L. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res. 2005 Aug 15;11(16):5678-85. doi: 10.1158/1078-0432.CCR-04-2421.
- published result linkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunwei Shen principal investigator
Shanghai Jiao Tong University School of Medicine
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel, Anthracycline (Doxorubicin or Epirubicin), Cyclophosphamide and Docetaxel, cyclophosphamide in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 27 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: TAC treatment was associated with better survial outcome compared with TC treatment, we terminated recruiting and waiting for longer follow up period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete remission (pCR) rate (time frame: after 6 cycles of neoadjuvant therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00912444, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.