Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer Metastatic, Chemotherapy Effect

Intervention / Treatment
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* Drug: Capecitabine, Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine, Cyclophosphamide|Capecitabine 500 mg times three, Cyclophosphamide 50 mg once daily|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rates | 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. | Complete response and Partial response | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Radiological and Clinical evaluation | From baseline until three months after last dose. | 
| Overall survival | Death | From baseline until death of any course assesed up to one year. | 
| Tolerance and safety assessment | Clinical evaluation | From baseline until three months after last dose. | 
| Health-related quality of life | 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. | 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 | 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 | Blood sample | From baseline until the date of first documented progression or date of death from any cause, whichever came first. |