Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca (TNM)

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: Breast Cancer
• Intervention / Treatment: Drug: Vinorelbine-Docetaxel; Drug: Vinorelbine

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

Study Locations

• Lebanon
  • Saida, Lebanon
    • Hammoud Hospital University Medical Center
  • Beirut
    • Achrafieh, Beirut, Lebanon
      • Hotel Dieu de France University Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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	Drug: 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: Taxotere; Navelbine; Navelbine Oral; Navelbine IV; Drug: Vinorelbine; 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: Navelbine Oral
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	Drug: 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: Taxotere; Navelbine; Navelbine Oral; Navelbine IV

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	Up to 36 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Cancer Research Group - Collaborative Group, Beirut, Lebanon.
• 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

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: Maintenance treatment; Advanced Breast Cancer; Oral Chemotherapy; Metastatic Breast Cancer; Oral Vinorelbine
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Docetaxel; Vinorelbine
• Other Study ID Numbers: CRG SE036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO