Breast Cancer Metastatic, Chemotherapy Effect
Conditions
Brief summary
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.
Interventions
DRUGCapecitabine, Cyclophosphamide
Capecitabine 500 mg times three, Cyclophosphamide 50 mg once daily
Sponsors
Vastra Gotaland Region
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rates | From baseline until three months after last dose. | Radiological and Clinical evaluation |
| 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. | 24 weeks | Complete response and Partial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance and safety assessment | From baseline until three months after last dose. | Clinical evaluation |
| Health-related quality of life | From baseline until three months after last dose. | EORTC-QLQ (Quality of Life Questionnaire)-30 |
| Progression free survival | From baseline until three months after last dose. | Radiological and Clinical evaluation |
| Evaluation of CA (cancer associated antigen) 15-3 in relation to treatment effect | From baseline until the date of first documented progression or date of death from any cause, whichever came first. | Blood sample |
| Evaluation of immune deficiency panel markers defined as changes in immune cell composition | From baseline until the date of first documented progression or date of death from any cause, whichever came first. | Blood sample |
| Evaluation of molecular characteristics in ctDNA (circulating tumor) defined as mutational changes. | From baseline until the date of first documented progression or date of death from any cause, whichever came first. | Blood sample |
| Overall survival | From baseline until death of any course assesed up to one year. | Death |
Countries
Sweden
Outcome results
None listed