Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer (METRO)

January 16, 2024 updated by: Vastra Gotaland Region

Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer - a Two Step Study With a Retrospective Analyses Followed by a Translational Phase II Study

Low dose metronomic chemotherapy (LDMC) in patients with metastatic breast cancer (MBC) is used as a palliative regiment with the aim to prolong and improve quality of life. The effect of LDMC is not fully elucidated. The aim is to evaluate the effect of LDMC with Capecitabine and Cyclophosphamide (CX) and to discover new potential predictive markers and potential markers for monitoring treatment effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Barbro Linderholm, Associate Proffessor
  • Phone Number: +4631-3421000

Study Locations

  • Sweden
    • Vastra Gotaland
      • Goteborg, Vastra Gotaland, Sweden, 405 83
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Metastatic breast cancer

Description

Inclusion Criteria:

  • Written and informed consent
  • Breast cancer confirmed by histology
  • Recurrence (local or distant) not possible to cure
  • Measurable or evaluable disease
  • Life expectancy of more than tree months
  • ECOG (Eastern Cooperative Oncology Group) performance 0-2
  • No or any lines of previous therapies for recurrent disease.
  • Adequate contraception for patients of Child bearing age.

Exclusion Criteria:

  • Clinically significant cardiovascular disease
  • Non healing wound, Active peptic ulcer or bone fracture
  • Evidence of any other disease that puts the patient at high risk for treatment-related complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rates
Time Frame: From baseline until three months after last dose.
Radiological and Clinical evaluation
From baseline until three months after last dose.
Clinical benefit defined as the proportion of patients with CR(complete respons) or PR(partial respons) and patients with stable disease for 24 weeks or more.
Time Frame: 24 weeks
Complete response and Partial response
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: From baseline until three months after last dose.
Radiological and Clinical evaluation
From baseline until three months after last dose.
Overall survival
Time Frame: From baseline until death of any course assesed up to one year.
Death
From baseline until death of any course assesed up to one year.
Tolerance and safety assessment
Time Frame: From baseline until three months after last dose.
Clinical evaluation
From baseline until three months after last dose.
Health-related quality of life
Time Frame: From baseline until three months after last dose.
EORTC-QLQ (Quality of Life Questionnaire)-30
From baseline until three months after last dose.
Evaluation of molecular characteristics in ctDNA (circulating tumor) defined as mutational changes.
Time Frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first.
Blood sample
From baseline until the date of first documented progression or date of death from any cause, whichever came first.
Evaluation of CA (cancer associated antigen) 15-3 in relation to treatment effect
Time Frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first.
Blood sample
From baseline until the date of first documented progression or date of death from any cause, whichever came first.
Evaluation of immune deficiency panel markers defined as changes in immune cell composition
Time Frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first.
Blood sample
From baseline until the date of first documented progression or date of death from any cause, whichever came first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-09-20 Version 1.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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