Back to results

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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

Lebanon

Study Type

Interventional

Intervention

Vinorelbine-Docetaxel

Vinorelbine

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Oral Vinorelbine, Oral Chemotherapy, Metastatic Breast Cancer, Advanced Breast Cancer, Maintenance treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hotel Dieu de France University Hospital
Hammoud Hospital University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Maintenance treatment

Observation arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Response Rate

Duration of Response

Quality of Life

Number and percentage of participants with Adverse Events

3-Y Overall Survival

Full Information

NCT ID

NCT02144194

First Posted

May 15, 2014

Last Updated

February 7, 2017

Sponsor

Cancer Research Group - Collaborative Group, Beirut, Lebanon.

1. Study Identification

Unique Protocol Identification Number

NCT02144194

Brief Title

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

Acronym

TNM

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Research Group - Collaborative Group, Beirut, Lebanon.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Maintenance treatment

Arm Type

Experimental

Arm Description

Arm Title

Observation arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vinorelbine-Docetaxel

Other Intervention Name(s)

Navelbine, Navelbine IV, Navelbine Oral, Taxotere

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Other Intervention Name(s)

Navelbine Oral

Intervention Description

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)

Primary Outcome Measure Information:

Title

Time Frame

Up to 36 months

Secondary Outcome Measure Information:

Title

Overall Response Rate

Time Frame

Up to 36 months

Title

Duration of Response

Time Frame

Up to 36 months

Title

Quality of Life

Time Frame

Up to 36 months

Title

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

Title

3-Y Overall Survival

Time Frame

Up to 36 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: