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

NCT02144194 | Unknown Phase 2

• 1 other identifier: CRG SE036
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Oral Vinorelbine; Oral Chemotherapy; Metastatic Breast Cancer; Advanced Breast Cancer; Maintenance treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Maintenance treatment

EXPERIMENTAL

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; Drug: Vinorelbine

Observation arm

EXPERIMENTAL

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

Interventions

Vinorelbine-Docetaxel DRUG

Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks x 6 cycles

Also known as: Navelbine, Navelbine IV, Navelbine Oral, Taxotere

Maintenance treatment; Observation arm

Vinorelbine DRUG

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)

Also known as: Navelbine Oral

Maintenance treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Hotel Dieu de France University Hospital

El Achrafiyé, Beyrouth, Lebanon

Location

Hammoud Hospital University Medical Center

Saida, Saida, Lebanon

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 21, 2014
• Study Start: March 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (2)