Breast Cancer
Conditions
Keywords
Oral Vinorelbine, Oral Chemotherapy, Metastatic Breast Cancer, Advanced Breast Cancer, Maintenance treatment
Brief summary
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.
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.
Interventions
DRUGVinorelbine-Docetaxel
Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks x 6 cycles
DRUGVinorelbine
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)
Sponsors
Cancer Research Group - Collaborative Group, Beirut, Lebanon.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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 | Up to 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate | Up to 36 months |
| Duration of Response | Up to 36 months |
| Quality of Life | Up to 36 months |
| Number and percentage of participants with Adverse Events | Participants will be followed for the entired duration of the study, an expected average of 60 months |
| 3-Y Overall Survival | Up to 36 months |
Countries
Lebanon
Outcome results
None listed