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The Trial Comparing Dose-dense AC-T With PC as Adjuvant Therapy for TNBC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01378533
Recruitment Status : Unknown
Verified December 2011 by li qing, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 22, 2011
Last Update Posted : December 28, 2011
Sponsor:
Information provided by (Responsible Party):
li qing, Chinese Academy of Medical Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: epirubicin, cyclophosphamide, paclitaxel, carboplatin, G-CSF Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: AC-T(dose-dense)
AC-T(dose-dense) EPI(Pharmorubicin) CTX(cyclophosphamide) PTX(Paclitaxel) G-CSF
Drug: epirubicin, cyclophosphamide, paclitaxel, carboplatin, 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 Name: pharmorubicin

Experimental: chemotherapy:PC
PTX(Paclitaxel) CBP(carboplatin)
Drug: epirubicin, cyclophosphamide, paclitaxel, carboplatin, 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 Name: pharmorubicin




Primary Outcome Measures :
  1. 3 years DFS [ Time Frame: 3 years ]
    the participants will be followed by the telephone for the duration, an expected average of 3 years.


Secondary Outcome Measures :
  1. Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: 3 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must accept the modified radical mastectomy
  2. Patients with histologically confirmed ER(-) PR(-) and HER-2(-)
  3. Positive axillary lymph nodes;negative axillary lymph node with age< 35 years or Ⅲ grade or intravascular cancer embolus.
  4. Age between 18 years to 65 years
  5. Able to give informed consent
  6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
  7. Not pregnant, and on appropriate birth control if of child-bearing potential.
  8. Adequate bone marrow reserve with ANC > 1000 and platelets > 100,000.
  9. Adequate renal function with serum creatinine < 2.0.
  10. 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.
  11. No active major medical or psychosocial problems that could be complicated by study participation.

Exclusion Criteria:

  1. received neo-adjuvant therapy
  2. 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
  3. Uncontrolled medical problems.
  4. Evidence of active acute or chronic infection.
  5. Pregnant or breast feeding.
  6. Hepatic, renal, or bone marrow dysfunction as detailed above.

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): NCT01378533


Contacts
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Contact: qing li, bachelor 0086-010-87788120 cheryliqing@yahoo.cn
Contact: ying han, master 0086-010-87788120 huani8023@gmail.com

Locations
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China, Beijing
Cancer institute and hospital Chinese academy of medical sciences Recruiting
Beijing, Beijing, China, 100021
Contact: qing li, bachelor    0086-010-87788120    cheryliqing@yahoo.cn   
Contact: ying han, master    0086-010-87788120    huani8023@gmail.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Study Chair: qing li, bachelor Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: li qing, chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01378533    
Other Study ID Numbers: CH-BC-012
CH-BC-012 ( Other Identifier: cancer hospital, chinese academy of medical sciences )
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: December 28, 2011
Last Verified: December 2011
Keywords provided by li qing, Chinese Academy of Medical Sciences:
triple-negative breast cancer
dose-dense
epirubicin and cyclophosphamide followed by paclitaxel(AC-T)
paclitaxel plus carboplatin(PC)
3 years DFS
the tolerance
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors