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To Determine the Objective Response Rate of 4 Cycles of Docetaxel + Anthracycline (Epirubicin or Doxorubicine) Followed by 4 Cycles of Docetaxel Single Agent

This study has been terminated.
(the study was early terminated due to lack of recruitment.)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00620100
First received: February 11, 2008
Last updated: May 29, 2009
Last verified: May 2009
  Purpose

To determine the Objective Response Rate of 4 cycles of docetaxel + anthracycline (epirubicin or doxorubicine) followed by 4 cycles of docetaxel single agent. To determine the Time to Tumor Progression (TTP), the Response Duration, the Overall Survival. To confirm the safety profile


Condition Intervention Phase
Breast Neoplasms
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel (Taxotere®) + Anthracycline (Epirubicin or Doxorubicin) x 4 Cycles Followed by Docetaxel (T) Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed > or = 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®-Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Evaluate the objective response rate according to RECIST guidelines after treatment with Taxoterer and anthracycline followed by Taxoterer single agent in the first line treatment of Her2 negative locally advanced or metastatic breast cancer [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the Time to Tumor Progression (TTP). [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • To evaluate the response duration. [ Time Frame: During all the study conduct ] [ Designated as safety issue: No ]
  • To evaluate the overall survival. [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • To confirm the safety profile. [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: September 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patient with histologically or cytologically documented breast adenocarcinoma
  2. First local or metastatic relapse
  3. Patients must have received a prior neoadjuvant or adjuvant Taxotere®-based chemotherapy regimen, provided this chemotherapy was completed > than or = to 12 months prior to enrollment date
  4. Prior hormone or immune therapy is allowed. Antitumoral adjuvant hormone therapy may be continued during the study period, provided it was started > 12 months prior to study enrollment
  5. Her2/neu negative tumor demonstrated by immunohistochemistry (IHC 0 or 1+) or by fluorescence in situ hybridation (FISH -). A patient with tumor assessed as 2+ by IHC can be enrolled if the tumor is negative by FISH.
  6. ECOG performance status of 0 to 2
  7. Normal cardiac function confirmed by LVEF or shortening fraction (MUGA scan or echocardiography, respectively, within normal limits for the institution) assessed within 3 months prior to study entry. An ECG must be obtained within 4 weeks prior study entry and must demonstrate no clinically significant abnormality.
  8. Patients are required to have at least one measurable lesion according to RECIST guidelines
  9. Adequate organ function defined by:

    1. Hematology: Neutrophils > than or = to 2.0 109/L, Platelets > than or = to 100 109/L, Hemoglobin > than or = to 10 g/dL
    2. Hepatic function: Total bilirubin within normal limits, AST (SGOT) and ALT (SGPT) < than or = to 1.5 UNL, alkaline phosphatase < than or = to 2.5 UNL (unless accompanied by extensive bone metastases)
  10. Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential
  11. Written informed consent prior to beginning specific protocol procedures must be obtained and documented according to the local regulatory requirements

Exclusion Criteria

  1. Prior therapy for advanced or recurrent disease
  2. Previous cumulative exposure to epirubicin > 600 mg/m² or to doxorubicin > 300 mg/m²
  3. Previous radiation therapy having involved more than 25% of bone marrow; incomplete recovery from toxicity of radiation therapy
  4. Symptomatic brain metastases and clinically diagnosed leptomeningeal metastases
  5. Isolated unmeasurable bone lesions, serous pleural effusion or pulmonary lymphangiitis (i.e., unmeasurable disease according to the RECIST guidelines)
  6. Pre-existing motor or sensory neurologic toxicity of a severity > than or = to grade 2 according to NCI-CTC AE criteria version 3.0
  7. Pregnant or lactating women or women of childbearing potential not using adequate contraception
  8. Other serious illness or medical conditions, including:

    1. 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
    2. History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent.
    3. Active uncontrolled infection
    4. Active peptic ulcer, uncontrolled diabetes mellitus
  9. Past or current history of neoplasm other than breast carcinoma, except:

    1. Curatively treated non-melanoma skin cancer.
    2. in situ carcinoma of the cervix.
    3. Other cancer curatively treated and with no evidence of disease for at least 10 years
  10. Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< than or = to 20 mg methylprednisolone per day or equivalent)
  11. Definite contraindications for the use of corticosteroids
  12. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)
  13. Concurrent treatment with other investigational drugs. Active treatment as part of another clinical therapeutic trial within 30 days prior to study entry
  14. Concurrent treatment with any other anti-cancer therapy, except adjuvant hormone therapy started > than or = to 12 months prior to study enrollment. Bisphosphonates for management of bone metastases or osteoporosis/osteopenia are allowed
  15. History of hypersensitivity to docetaxel (or drugs formulated in polysorbate 80), epirubicin or doxorubicin
  16. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  17. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

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

  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: NCT00620100

Locations
Austria
Sanofi-Aventis
Vienna, Austria
Poland
Sanofi-aventis
Warsaw, Poland
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Véronique AGNETTI Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00620100     History of Changes
Other Study ID Numbers: XRP6976A_2504
Study First Received: February 11, 2008
Last Updated: May 29, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Docetaxel
Doxorubicin
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014