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

Cancer Research Group - Collaborative Group, Beirut, Lebanon.

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Vinorelbine; Drug: Vinorelbine-Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02144194

CRG SE036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Maintenance treatment

Experimental group

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

Treatment:

Drug: Vinorelbine-Docetaxel

Drug: Vinorelbine

Observation arm

Experimental group

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 Patients in the observation arm will not be administered any treatment after Vinorelbine-Docetaxel

Treatment:

Drug: Vinorelbine-Docetaxel