NCT04350021CompletedNot Applicable
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
Vastra Gotaland Region1 site in 1 country40 target enrollmentStarted: March 1, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Overall response rates
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Overall response rates
Time Frame: 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.
Time Frame: 24 weeks
Complete response and Partial response
Secondary Outcomes
- Progression free survival(From baseline until three months after last dose.)
- Overall survival(From baseline until death of any course assesed up to one year.)
- Tolerance and safety assessment(From baseline until three months after last dose.)
- Health-related quality of life(From baseline until three months after last dose.)
- 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.)
- 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.)
- 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.)
Investigators
Study Sites (1)
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