A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes

NCT ID: NCT01589159

Last Updated: 2017-02-27

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-31

Brief Summary

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This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and safety study. Eligible patients are enrolled in a single group. The investigators propose to determine the efficacy and safety of low-dose metronomic chemotherapy with Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and/or Taxanes.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

Drug:capecitabine 700mg/m2, twice daily on days 1-14.

Etoposide

Intervention Type DRUG

Etoposide 30mg/m2, once daily on days 1-7.

Interventions

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Capecitabine

Drug:capecitabine 700mg/m2, twice daily on days 1-14.

Intervention Type DRUG

Etoposide

Etoposide 30mg/m2, once daily on days 1-7.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female patients between 18 and 65 years old
* patients with metastatic breast cancer previousely treated with A/T
* able and willing to give consent to participate in the study

Exclusion Criteria

* pregnant or lactating females
* other tumor history
* instable complication (e.g., myocardial infarction within 6 months,arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection
* concurrent disease or condition that would make the patient inappropriate for study participation
* resist to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tao OUYANG

OTHER

Sponsor Role lead

Responsible Party

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Tao OUYANG

Chairman of Breast Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yan Wei, Doctor

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

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Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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BCP09

Identifier Type: -

Identifier Source: org_study_id

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