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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04350021
Other study ID # 2018-09-20 Version 1.2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date October 30, 2023

Study information

Verified date January 2024
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Capecitabine, Cyclophosphamide
Capecitabine 500 mg times three, Cyclophosphamide 50 mg once daily

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Goteborg Vastra Gotaland

Sponsors (1)

Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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

Outcome

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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