Clinical trial NCT02144194: Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca
Official title: TNM Trial: Upfront Docetaxel [T] and Alternating iv and Oral Vinorelbine [N] Followed, by Either Maintenance Oral Vinorelbine, or Observation for Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Oral Vinorelbine
Oral Chemotherapy
Metastatic Breast Cancer
Advanced Breast Cancer
Maintenance treatment
Lead sponsor: Cancer Research Group - Collaborative Group, Beirut, Lebanon.
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 36 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 36 months
measure: Duration of Response
timeFrame: Up to 36 months
measure: Quality of Life
timeFrame: Up to 36 months
measure: Number and percentage of participants with Adverse Events
timeFrame: Participants will be followed for the entired duration of the study, an expected average of 60 months
measure: 3-Y Overall Survival
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Achrafieh
country: Lebanon
facility: Hotel Dieu de France University Hospital
state: Beirut
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
Study officials:
affiliation: Hammoud Hospital University Medical Center
name: Fadi Farhat, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu De France University Hospital
name: Marwan Ghosn, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu de France University Hospital
name: Georges Chahine, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu de France University Hospital
name: Joseph Kattan, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahel General Hospital
name: Nizar Bitar, M.D
role: PRINCIPAL_INVESTIGATOR
References: