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Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer

NCT ID: NCT01941771

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-03-31

Brief Summary

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The study hypothesis is that metronomic treatment is more efficient than standard treatment.

Detailed Description

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Purpose: In an open-label randomized phase II trial, patients with metastatic Human Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant WHO performance status \< 3 are randomized to receive either capecitabine (day 1-14) plus vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic (3 days a week).

Conditions

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Breast Cancer

Keywords

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Breast cancer Metronomic chemotherapy Vinorelbine Navelbine Capecitabine Xeloda Antineoplastic Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.

Group Type ACTIVE_COMPARATOR

Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Intervention Type DRUG

Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.

Arm B

Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.

Group Type EXPERIMENTAL

Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Intervention Type DRUG

Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.

Interventions

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Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.

Intervention Type DRUG

Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.

Intervention Type DRUG

Other Intervention Names

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Vinorelbine (Navelbine oral) Capecitabine (Xeloda) Other Names: Vinorelbine (Navelbine oral) Capecitabine (Xeloda)

Eligibility Criteria

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Inclusion Criteria

* Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer
* WHO performance status \< 3

Exclusion Criteria

* Former treatment with Capecitabine or Vinorelbine
* Patients who have received more than one line of chemotherapy for metastatic disease
* Brain metastases
* Malabsorption syndrome
* Abnormal organ function
* pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pierre Fabre Laboratories

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Sven Langkjer

consultant, MD, ph.d.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sven Tyge Langkjer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University hospital of Aarhus

Locations

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Department of Oncology, Aarhus University Hospital

Aarhus, Aarhus C, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2011-003564-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EUDRACT nr. 2011-003564-72

Identifier Type: -

Identifier Source: org_study_id