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

NCT00620100 | Terminated Phase 2

• 1 other identifier: XRP6976A_2504
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  During the study conduct

Secondary Outcomes (4)

• To evaluate the Time to Tumor Progression (TTP).

  During the study conduct

• To evaluate the response duration.

  During all the study conduct

• To evaluate the overall survival.

  During the study conduct

• To confirm the safety profile.

  from the inform consent signed up to the end of the study

Interventions

Docetaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient with histologically or cytologically documented breast adenocarcinoma
• First local or metastatic relapse
• 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
• 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
• 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.
• ECOG performance status of 0 to 2
• 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.
• Patients are required to have at least one measurable lesion according to RECIST guidelines
• Adequate organ function defined by:
• Hematology: Neutrophils \> than or = to 2.0 109/L, Platelets \> than or = to 100 109/L, Hemoglobin \> than or = to 10 g/dL
• 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)
• Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential
• Written informed consent prior to beginning specific protocol procedures must be obtained and documented according to the local regulatory requirements

You may not qualify if:

• Prior therapy for advanced or recurrent disease
• Previous cumulative exposure to epirubicin \> 600 mg/m² or to doxorubicin \> 300 mg/m²
• Previous radiation therapy having involved more than 25% of bone marrow; incomplete recovery from toxicity of radiation therapy
• Symptomatic brain metastases and clinically diagnosed leptomeningeal metastases
• Isolated unmeasurable bone lesions, serous pleural effusion or pulmonary lymphangiitis (i.e., unmeasurable disease according to the RECIST guidelines)
• Pre-existing motor or sensory neurologic toxicity of a severity \> than or = to grade 2 according to NCI-CTC AE criteria version 3.0
• Pregnant or lactating women or women of childbearing potential not using adequate contraception
• Other serious illness or medical conditions, including:
• 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 hamper understanding and giving informed consent.
• Active uncontrolled infection
• Active peptic ulcer, uncontrolled diabetes mellitus
• Past or current history of neoplasm other than breast carcinoma, except:
• Curatively treated non-melanoma skin cancer.
• in situ carcinoma of the cervix.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Sanofi-Aventis

Vienna, Austria

Location

Sanofi-aventis

Warsaw, Poland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Véronique AGNETTI

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: September 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: June 3, 2009

Record last verified: 2009-05

Locations

PL (1); AU (1)