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Completed

NCT Number: NCT04350021

Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer

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.

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Key information

Conditions

Breast Cancer Metastatic Chemotherapy Effect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 405 83, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine, Cyclophosphamide

Drug

Capecitabine 500 mg times three, Cyclophosphamide 50 mg once daily

Primary outcomes

  1. Overall response rates

    Time frame: From baseline until three months after last dose.

    Radiological and Clinical evaluation

  2. 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

Secondary outcomes

  1. Progression free survival

    Time frame: From baseline until three months after last dose.

    Radiological and Clinical evaluation

  2. Overall survival

    Time frame: From baseline until death of any course assesed up to one year.

    Death

  3. Tolerance and safety assessment

    Time frame: From baseline until three months after last dose.

    Clinical evaluation

  4. Health-related quality of life

    Time frame: From baseline until three months after last dose.

    EORTC-QLQ (Quality of Life Questionnaire)-30

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Acronym: METRO

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2020
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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