- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00620100
To Determine the Objective Response Rate of 4 Cycles of Docetaxel + Anthracycline (Epirubicin or Doxorubicine) Followed by 4 Cycles of Docetaxel Single Agent
May 29, 2009 updated by: Sanofi
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
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
During the study conduct
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the Time to Tumor Progression (TTP).
Time Frame: During the study conduct
|
During the study conduct
|
To evaluate the response duration.
Time Frame: During all the study conduct
|
During all the study conduct
|
To evaluate the overall survival.
Time Frame: During the study conduct
|
During the study conduct
|
To confirm the safety profile.
Time Frame: from the inform consent signed up to the end of the study
|
from the inform consent signed up to the end of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Véronique AGNETTI, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
April 1, 2005
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
February 11, 2008
First Submitted That Met QC Criteria
February 20, 2008
First Posted (Estimate)
February 21, 2008
Study Record Updates
Last Update Posted (Estimate)
June 3, 2009
Last Update Submitted That Met QC Criteria
May 29, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XRP6976A_2504
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Neoplasms
-
Seagen Inc.CompletedTriple Negative Breast Neoplasms | Hormone Receptor Positive Breast Neoplasms | HER2 Positive Breast Neoplasms | HER2 Mutations Breast NeoplasmsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Celgene CorporationTerminatedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
-
Dana-Farber Cancer InstituteConquer Cancer FoundationRecruitingBreast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | HER2-positive Breast Cancer | Inflammatory Breast Cancer | Hormone Receptor Positive Malignant Neoplasm of BreastUnited States
-
GlaxoSmithKlineCompletedNeoplasms, BreastUnited States, Spain, Israel, Canada, Belgium, United Kingdom, France, Tunisia
-
GlaxoSmithKlineCompletedNeoplasms, BreastUnited States, Canada, Germany, Spain, Taiwan, Belgium, Philippines, Israel, Hong Kong, Thailand, Pakistan, Russian Federation, Italy, Romania, China, France, Peru, United Kingdom, Czech Republic, Australia, Chile, Korea, Republic of and more
-
Oslo University HospitalKarolinska Institutet; Hoffmann-La Roche; Rigshospitalet, Denmark; Helse Stavanger... and other collaboratorsCompletedTriple Negative Breast Cancer | Cancer, BreastNorway, Denmark
-
MedSIRHoffmann-La RocheCompletedAdvanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast CancerSpain, France, United Kingdom, Germany, Italy
-
Centro Hospitalar Lisboa OcidentalInstituto Nacional de Medicina Legal e Ciências Forenses, Delegação do SulUnknownMale Breast Cancer | Female Breast Cancer
Clinical Trials on Docetaxel
-
Nereus Pharmaceuticals, Inc.CompletedCancerUnited States, Australia, India, Chile, Brazil, Argentina
-
Tianjin Medical University Cancer Institute and...Recruiting
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaboratorsUnknownGastric CancerKorea, Republic of
-
Zhuhai Beihai Biotech Co., LtdCompletedSolid Tumours | Bioequivalence | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaCompletedNon-Small Cell Lung Cancer (NSCLC)China
-
Optimal Health ResearchCompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Arog Pharmaceuticals, Inc.WithdrawnCarcinoma, Non-Small-Cell Lung
-
Boehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungJapan
-
SanofiCompletedLung NeoplasmsFrance, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom
-
SanofiCompleted