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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02144194 |
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Date of registration:
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15/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca
TNM |
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Scientific title:
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TNM Trial: Upfront Docetaxel [T] and Alternating iv and Oral Vinorelbine [N] Followed, by Either Maintenance Oral Vinorelbine, or Observation for Advanced Breast Cancer |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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65 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02144194 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Georges Chahine, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hotel Dieu de France University Hospital |
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Name:
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Fadi Farhat, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hammoud Hospital University Medical Center |
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Name:
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Nizar Bitar, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sahel General Hospital |
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Name:
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Marwan Ghosn, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hotel Dieu De France University Hospital |
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Name:
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Joseph Kattan, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hotel Dieu de France University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent
- Patients >=18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the breast that is now
metastatic or locally-recurrent and inoperable with curative intent
- Measurable and/or non-measurable disease
- The patient's primary and/or metastatic tumor is HER2 neu negative
- Documented metastatic disease previously untreated with palliative chemotherapy
- Adjuvant or neo-adjuvant chemotherapy (including treatment with docetaxel or any other
chemotherapy) is allowed with a disease free survival of at least 6 months
- No symptom or sign of brain metastasis
Exclusion Criteria:
- Operable local recurrence
- Ascites or pericardial effusion as only site of metastasis
- Symptomatic peripheral neuropathy > grade 1 according to the NCI Common Toxicity
Criteria
- Radiotherapy to all areas of evaluable disease within the previous 4 weeks
- Disease significantly affecting absorption
- Severe hepatic insufficiency
- Patient previously treated with chemotherapy for their metastatic disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Vinorelbine-Docetaxel
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Drug: Vinorelbine
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Primary Outcome(s)
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Time To Disease Progression of patients who are treated with Vinorelbine-Docetaxel followed by maintenance oral Vinorelbine vs patients treated with Vinorelbine-Docetaxel without maintenance treatment
[Time Frame: Up to 36 months]
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Secondary Outcome(s)
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Duration of Response
[Time Frame: Up to 36 months]
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Number and percentage of participants with Adverse Events
[Time Frame: Participants will be followed for the entired duration of the study, an expected average of 60 months]
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3-Y Overall Survival
[Time Frame: Up to 36 months]
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Overall Response Rate
[Time Frame: Up to 36 months]
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Quality of Life
[Time Frame: Up to 36 months]
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Secondary ID(s)
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CRG SE036
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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