- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01378533
The Trial Comparing Dose-dense AC-T With PC as Adjuvant Therapy for TNBC
Randomized Phase Ⅲ Trial Comparing Dose-dense Epirubicin and Cyclophosphamide Followed by Paclitaxel With Paclitaxel Plus Carboplatin as Adjuvant Therapy for Triple-negative Breast Cancer.
The purpose of this trial is to compare the 3 years DFS of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancer.
The other purpose of this trial is to observe the patient's tolerance.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breast cancer are heterogeneous group of tumors with diverse behavior, outcome, and sensitivity to therapy.In recent years, the term triple negative (TN) breast cancer has emerged to describe those cancers which do not express oestrogen (ER) , progesterone (PR) receptors, or Her2. Many studies had estimated that TN cases represents between 12%-20% of all breast cancers. Those TN case constitute one of the most challenging breast cancer groups, with only systemic chemotherapy is currently available for their treatment.
BRCA1 protein normally functions as a negative regulator of the cell cycle, also, BRCA1-positive tumors encompass a heterogeneous group of tumors that show distinctive pathological and clinical features. BRCA1-associated cancers are typically high-grade invasive duct carcinoma and are mostly triple negative.The phenotypic and molecular similarity of the TNBCs to BRCA1-associated BCs might be of use in designing their treatment protocol. There is increasing evidence that the DNA repair defects that are characteristic of BRCA-1 related cancers may provide sensitivity to certain systemic agents to treat TNBC patients such as the bifunctional alkylating agents and platinum drugs.
Dose density refers to the administration of drugs with a shortened intertreatment interval. It is based on the observation that in experimental models, a given dose always kills a certain fraction, rather than a certain number, of exponentially growing cancer cells. Because human cancers in general, and breast cancers in particular, usually grow by nonexponential Gompertzian kinetics, this model has been extended to those situations. Regrowth of cancer cells between cycles of cytoreduction is more rapid in volume-reduced Gompertzian cancer models than in exponential models. Hence it has been hypothesized that the more frequent administration of cytotoxic therapy would be a more effective way of minimizing residual tumor burden than dose escalation. In the INT C9741 trial, the dose-dense schedule is accomplished by using granulocyte colony-stimulating factor (filgrastim) to permit every-2-week recycling of the drugs A, T and C at their optimal dose levels rather than at the conventional 3-week intervals.Sequential therapy refers to the application of treatments one at a time rather than concurrently. It does not challenge the concept that multiple drugs are needed to maximally perturb cancers that are composed of cells heterogeneous in drug sensitivity. Rather, it hypothesizes that for slow-growing cancers like most breast cancers, it is more important to preserve dose density than to force a combination, especially if that combination would be more toxic and requires dose-reductions or delays in drug administration. If dose density is the same in a sequential combination chemotherapy regimen and a concurrent combination regimen, theoretical considerations indicate that the therapeutic result should be the same, even if the sequential pattern happens to be less toxic.
In our trial, we want to compare the 3 years DFS of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancer.The other purpose of this trial is to observe the patient's tolerance.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: qing li, bachelor
- Phone Number: 0086-010-87788120
- Email: cheryliqing@yahoo.cn
Study Contact Backup
- Name: ying han, master
- Phone Number: 0086-010-87788120
- Email: huani8023@gmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- Cancer Institute and Hospital Chinese Academy of Medical Sciences
-
Contact:
- qing li, bachelor
- Phone Number: 0086-010-87788120
- Email: cheryliqing@yahoo.cn
-
Contact:
- ying han, master
- Phone Number: 0086-010-87788120
- Email: huani8023@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient must accept the modified radical mastectomy
- Patients with histologically confirmed ER(-) PR(-) and HER-2(-)
- Positive axillary lymph nodes;negative axillary lymph node with age< 35 years or Ⅲ grade or intravascular cancer embolus.
- Age between 18 years to 65 years
- Able to give informed consent
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- Not pregnant, and on appropriate birth control if of child-bearing potential.
- Adequate bone marrow reserve with ANC > 1000 and platelets > 100,000.
- Adequate renal function with serum creatinine < 2.0.
- Adequate hepatic reserve with serum bilirubin < 2.0, AST/ALT < 2X the upper limit of normal, and alkaline phosphatase < 5X the upper limit of normal. Serum bilirubin > 2.0 is acceptable in the setting of known Gilbert's syndrome.
- No active major medical or psychosocial problems that could be complicated by study participation.
Exclusion Criteria:
- received neo-adjuvant therapy
- Cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (MUGA) scan, or 45% by echocardiogram. -The rate of Disease recurrence
- Uncontrolled medical problems.
- Evidence of active acute or chronic infection.
- Pregnant or breast feeding.
- Hepatic, renal, or bone marrow dysfunction as detailed above.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AC-T(dose-dense)
AC-T(dose-dense) EPI(Pharmorubicin) CTX(cyclophosphamide) PTX(Paclitaxel) G-CSF
|
epirubicin 80mg/m2 iv d1 or divide in two days cyclophosphamide 600mg/m2 iv d1 G-CSF 3ug/kg ih d5-9 q14d*4cycles paclitaxel 175mg/m2 iv d1 G-CSF 3ug/kg ih d5-9 q14d*4cycles paclitaxel 150mg/m2 iv d1 carboplatin AUC=3 iv d2 G-CSF 3ug/kg ih d5-9 q14d*8cycles
Other Names:
|
Experimental: chemotherapy:PC
PTX(Paclitaxel) CBP(carboplatin)
|
epirubicin 80mg/m2 iv d1 or divide in two days cyclophosphamide 600mg/m2 iv d1 G-CSF 3ug/kg ih d5-9 q14d*4cycles paclitaxel 175mg/m2 iv d1 G-CSF 3ug/kg ih d5-9 q14d*4cycles paclitaxel 150mg/m2 iv d1 carboplatin AUC=3 iv d2 G-CSF 3ug/kg ih d5-9 q14d*8cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3 years DFS
Time Frame: 3 years
|
the participants will be followed by the telephone for the duration, an expected average of 3 years.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity as assessed by NCI CTCAE v3.0
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Investigators
- Study Chair: qing li, bachelor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Carboplatin
- Paclitaxel
- Epirubicin
Other Study ID Numbers
- CH-BC-012 (Other Identifier: cancer hospital, chinese academy of medical sciences)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of California, IrvineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBreast Cancer | HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-positive Breast CancerUnited States
Clinical Trials on epirubicin, cyclophosphamide, paclitaxel, carboplatin, G-CSF
-
Hebei Medical University Fourth HospitalWithdrawnTriple Negative Breast CancerChina
-
Centre Georges Francois LeclercRecruiting
-
Lund University HospitalDanish Breast Cancer Cooperative Group; Swedish Breast Cancer Group; Finnish... and other collaboratorsRecruitingBreast Cancer | Triple Negative Breast NeoplasmsDenmark, Sweden
-
Shengjing HospitalRecruiting
-
Tianjin Medical University Cancer Institute and...UnknownMetastatic Breast CancerChina
-
Cancer Institute and Hospital, Chinese Academy...UnknownBreast Cancer | Neoadjuvant ChemotherapyChina
-
Cancer Institute and Hospital, Chinese Academy...UnknownTriple Negative Breast CancerChina
-
Groupe Hospitalier Diaconesses Croix Saint-SimonGERCOR - Multidisciplinary Oncology Cooperative GroupRecruitingOvarian Cancer, EpithelialFrance
-
Fudan UniversityRecruitingTNBC - Triple-Negative Breast CancerChina
-
Hebei Medical University Fourth HospitalBeijing 302 Hospital; CSPC Ouyi Pharmaceutical Co., Ltd.UnknownBreast Cancer | Triple-negative Breast Cancer | Nab-paclitaxelChina