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

NCT ID: NCT02144194

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Vinorelbine-Docetaxel

Intervention Type: DRUG

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

Vinorelbine

Intervention Type: 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)

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

Group Type: EXPERIMENTAL

Vinorelbine-Docetaxel

Intervention Type: DRUG

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

Interventions

Vinorelbine-Docetaxel

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

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

Navelbine; Navelbine IV; Navelbine Oral; Taxotere; Navelbine Oral

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research Group - Collaborative Group, Beirut, Lebanon.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fadi Farhat, M.D

Role: PRINCIPAL_INVESTIGATOR

Hammoud Hospital University Medical Center

Marwan Ghosn, M.D

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu De France University Hospital

Georges Chahine, M.D

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu de France University Hospital

Joseph Kattan, M.D

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu de France University Hospital

Nizar Bitar, M.D

Role: PRINCIPAL_INVESTIGATOR

Sahel General Hospital

Locations

Hotel Dieu de France University Hospital

El Achrafiyé, Beyrouth, Lebanon

Hammoud Hospital University Medical Center

Saida, Saida, Lebanon

Countries

Lebanon

Other Identifiers

CRG SE036

Identifier Type: -

Identifier Source: org_study_id