Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca (TNM)
February 7, 2017 updated by: Cancer Research Group - Collaborative Group, Beirut, Lebanon.
TNM Trial: Upfront Docetaxel [T] and Alternating iv and Oral Vinorelbine [N] Followed, by Either Maintenance Oral Vinorelbine, or Observation for Advanced Breast Cancer
This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel combination given as an initial upfront treatment (first line) to all metastatic breast cancer patients enrolled.
Patients having a disease control following initial treatment, will be randomized to either oral Vinorelbine maintenance arm or Observation arm.
The trial will also compare the efficacy and safety of maintenance oral Vinorelbine versus Observation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
To our knowledge, this is the first trial evaluating the role of oral Vinorelbine as a maintenance therapy versus observation following a first line treatment with iv/oral Vinorelbine+Docetaxel.
Eligible patients will be enrolled in the trial to receive 6 cycles of iv(D1)/oral(D8) Vinorelbine + Docetaxel.
For responding and SD patients, after the 6 cycles, they will be randomized either in observation arm or to receive a maintenance chemotherapy with oral Vinorelbine.
The oral form of the drug was found to be most appropriate for a long term treatment allowing to preserve QoL of the patients.
Oral Vinorelbine will be administered on D1, D8 every 3 weeks during maintenance treatment, until PD, unacceptable toxicity or patient refusal to continue.
The trial will assess efficacy/safety of initial Vinorelbine-Docetaxel combination as well as the benefits of maintenance chemotherapy with oral Vinorelbine.
Study Type
Interventional
Enrollment (Actual)
65
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.
Study Locations
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Saida, Lebanon
- Hammoud Hospital University Medical Center
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Beirut
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Achrafieh, Beirut, Lebanon
- Hotel Dieu de France University Hospital
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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:
- 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
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Maintenance treatment
Initial treatment Vinorelbine-Docetaxel Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks for 6 cycles Followed by: Oral Vinorelbine 60mg/m2 D1, D8 or 80mg/m2 D1, D8 (dose schedule at investigator's discretion) Every 3 weeks until disease progression, unacceptable toxicities or patient refusal to continue |
Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks x 6 cycles
Other Names:
Oral Vinorelbine 60mg/m2 or 80mg/m2 D1, D8 every 3 weeks until disease progression, unacceptable toxicities or patient refusal to continue (dose schedule is at investigator's discretion)
Other Names:
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|
EXPERIMENTAL: Observation arm
Initial treatment: Vinorelbine-Docetaxel Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks for 6 cycles Patients in the observation arm will not be administered any treatment after Vinorelbine-Docetaxel |
Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks x 6 cycles
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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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Up to 36 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Response Rate
Time Frame: Up to 36 months
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Up to 36 months
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Duration of Response
Time Frame: Up to 36 months
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Up to 36 months
|
|
Quality of Life
Time Frame: Up to 36 months
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Up to 36 months
|
|
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
|
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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Up to 36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fadi Farhat, M.D, Hammoud Hospital University Medical Center
- Principal Investigator: Marwan Ghosn, M.D, Hotel Dieu de France University Hospital
- Principal Investigator: Georges Chahine, M.D, Hotel Dieu de France University Hospital
- Principal Investigator: Joseph Kattan, M.D, Hotel Dieu de France University Hospital
- Principal Investigator: Nizar Bitar, M.D, Sahel General Hospital
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
March 1, 2012
Primary Completion (ANTICIPATED)
June 1, 2017
Study Completion (ANTICIPATED)
December 1, 2017
Study Registration Dates
First Submitted
May 15, 2014
First Submitted That Met QC Criteria
May 19, 2014
First Posted (ESTIMATE)
May 21, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2017
Last Update Submitted That Met QC Criteria
February 7, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRG SE036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.