Chemotherapy Effect Clinical Trial
— METROOfficial 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
Verified date | January 2024 |
Source | Vastra Gotaland Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Goteborg | Vastra Gotaland |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region |
Sweden,
Colleoni M, Rocca A, Sandri MT, Zorzino L, Masci G, Nole F, Peruzzotti G, Robertson C, Orlando L, Cinieri S, de BF, Viale G, Goldhirsch A. Low-dose oral methotrexate and cyclophosphamide in metastatic breast cancer: antitumor activity and correlation with vascular endothelial growth factor levels. Ann Oncol. 2002 Jan;13(1):73-80. doi: 10.1093/annonc/mdf013. — View Citation
Dellapasqua S, Bertolini F, Bagnardi V, Campagnoli E, Scarano E, Torrisi R, Shaked Y, Mancuso P, Goldhirsch A, Rocca A, Pietri E, Colleoni M. Metronomic cyclophosphamide and capecitabine combined with bevacizumab in advanced breast cancer. J Clin Oncol. 2008 Oct 20;26(30):4899-905. doi: 10.1200/JCO.2008.17.4789. Epub 2008 Sep 15. — View Citation
Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rates | Radiological and Clinical evaluation | From baseline until three months after last dose. | |
Primary | 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 | Progression free survival | Radiological and Clinical evaluation | From baseline until three months after last dose. | |
Secondary | Overall survival | Death | From baseline until death of any course assesed up to one year. | |
Secondary | Tolerance and safety assessment | Clinical evaluation | From baseline until three months after last dose. | |
Secondary | Health-related quality of life | EORTC-QLQ (Quality of Life Questionnaire)-30 | From baseline until three months after last dose. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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