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Trial record 1 of 1 for:    BCIRG 005
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Docetaxel in Breast Cancer

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ClinicalTrials.gov Identifier: NCT00312208
Recruitment Status : Completed
First Posted : April 7, 2006
Results First Posted : February 17, 2010
Last Update Posted : December 30, 2013
Sponsor:
Collaborator:
Cancer International Research Group (CIRG)
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary objective :

  • To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes.

Secondary objectives :

  • To compare toxicity and quality of life between the 2 above-mentioned arms.
  • To evaluate pathologic and molecular markers for predicting efficacy.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel, doxorubicin, cyclophosphamide Drug: Docetaxel,doxorubicin, cyclophosphamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment of Operable Breast Cancer HER2neu Negative Patients With Positive Axillary Lymph Nodes
Study Start Date : November 2001
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1
Doxorubicin in combination with cyclophosphamide followed by docetaxel (AC -> T)
Drug: Docetaxel,doxorubicin, cyclophosphamide
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.

Experimental: 2
Docetaxel in combination with doxorubicin and cyclophosphamide (TAC)
Drug: docetaxel, doxorubicin, cyclophosphamide
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.




Primary Outcome Measures :
  1. Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) [ Time Frame: Median follow-up 65 months ]
    The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.


Secondary Outcome Measures :
  1. Death From Any Cause (Overall Survival) [ Time Frame: Median follow-up of 65 months ]
    The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria :

  • Histologically proven breast cancer. Interval between definitive surgery that includes axillary lymph node dissection and registration is less than or equal to 60 days. A central pathology review may be performed post randomization for confirmation of diagnosis and molecular studies.
  • Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer (T1-3, Clinical N0-1, M0). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and Ductal Carcinoma In Situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.
  • Histologic examination of the tumor: Invasive adenocarcinoma with at least one axillary lymph node (pN1) showing evidence of tumor among a minimum of six resected lymph nodes.
  • Tumor must show negative HER2 neu proto-oncogene overexpression by FISH (Fluorescence In Situ Hybridization). Confirmation of non overexpression will be centrally assessed by authorized BCIRG (Breast Cancer International Research Group) laboratories prior to randomization.
  • Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization.(Note: Patients whose tumor is estrogen receptor negative with progesterone receptor status unknown or undetermined, must have the progesterone receptor assayed in order to determine hormonal receptor status. Patients whose tumor is progesterone receptor negative with estrogen receptor status unknown or undetermined, must have the estrogen receptor assayed in order to determine hormonal receptor status).
  • Karnofsky Performance status index > 80%.
  • Normal cardiac function must be confirmed by LVEF (Lef Ventricular Ejection Fraction) i.e. MUGA (Multi Gated Acquisition) scan or echocardiography and ECG within 3 months prior to registration. LVEF result must be above or equal to the lower limit of normal for the institution. The ECG results must be within normal limits or show no significant abnormalities.
  • Laboratory requirements: (within 14 days prior to registration)

    • Hematology:

      • Neutrophils > or = 2.0 x 10^9/L
      • Platelets > or = 100 x 10^9/L
      • Hemoglobin > or = 10 g/dL
    • Hepatic function:

      • Total bilirubin < or = 1 UNL (Upper Normal Limit)
      • ASAT (Aspartate Amino Transferase) and ALAT (Alanine Amino Transferase) < or = 2.5 UNL
      • Alkaline phosphatase < or = 5 UNL
      • Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.
    • Renal function:

      • Creatinine < or = 175 µmol/L (2 mg/dL);
      • If limit reached, the calculated creatinine clearance should be > or = 60mL/min.
  • Complete staging work-up within 3 months prior to registration. All patients will have contralateral mammography, chest X-ray (Posteroanterior and lateral) and/or CT scan and/or MRI (Magnetic Resonance Imaging), abdominal ultrasound and/or CT scan (computerized tomography) and/or MRI, and bone scan. In case of positive bone scan, bone X-ray is mandatory to rule out the possibility of non-metastatic hot spots. Other tests may be performed as clinically indicated.
  • Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.

Exclusion Criteria :

  • Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, genetherapy , chemotherapy).
  • Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
  • Prior radiation therapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant, or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment (chemotherapy and tamoxifen therapy) and must have negative urine or serum pregnancy test within 7 days prior to registration.
  • Any T4 or N2 or known N3 or M1 breast cancer.
  • Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI-CTC (National Cancer Institute - Common Toxicity Criteria), version 2.0.
  • Other serious illness or medical condition:

    • congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
    • history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
    • active uncontrolled infection
    • active peptic ulcer, unstable diabetes mellitus
  • Past or current history of neoplasm other than breast carcinoma, except for:

    • curatively treated non-melanoma skin cancer
    • carcinoma in situ of the cervix
    • other cancer curatively treated and with no evidence of disease for at least 10 years
    • ipsilateral ductal carcinoma in-situ (DCIS) of the breast
    • lobular carcinoma in-situ (LCIS) of the breast
  • Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< 20 mg methylprednisolone or equivalent).
  • Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.
  • Definite contraindications for the use of corticosteroids.
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
  • Concurrent treatment with any other anti-cancer therapy.
  • Current therapy with any hormonal agent such as raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. Patients must have discontinued these agents prior to randomization.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT00312208


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Sponsors and Collaborators
Sanofi
Cancer International Research Group (CIRG)
Investigators
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Study Director: Jean-Philippe AUSSEL Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00312208     History of Changes
Other Study ID Numbers: TAX_GMA_301
BCIRG 005
First Posted: April 7, 2006    Key Record Dates
Results First Posted: February 17, 2010
Last Update Posted: December 30, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Liposomal doxorubicin
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