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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine, Cyclophosphamide | Drug | Capecitabine 500 mg times three, Cyclophosphamide 50 mg once daily |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Radiological and Clinical evaluation | From baseline until three months after last dose. |
| Overall survival | Death |
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Inclusion Criteria:
Exclusion Criteria:
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Metastatic breast cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Västra Götaland County | 405 83 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11863115 | Background | 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. | |
| 28564564 |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| 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. |
| 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. |
| 18794539 | Background | 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. |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |