Status:
TERMINATED
To Determine the Objective Response Rate of 4 Cycles of Docetaxel + Anthracycline (Epirubicin or Doxorubicine) Followed by 4 Cycles of Docetaxel Single Agent
Lead Sponsor:
Sanofi
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 Progressio...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion Criteria
- 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.
- Other cancer curatively treated and with no evidence of disease for at least 10 years
- 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)
- Definite contraindications for the use of corticosteroids
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)
- Concurrent treatment with other investigational drugs. Active treatment as part of another clinical therapeutic trial within 30 days prior to study entry
- 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
- History of hypersensitivity to docetaxel (or drugs formulated in polysorbate 80), epirubicin or doxorubicin
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00620100
Start Date
September 1 2004
End Date
April 1 2005
Last Update
June 3 2009
Active Locations (2)
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1
Sanofi-Aventis
Vienna, Austria
2
Sanofi-aventis
Warsaw, Poland