Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer

Chemotherapy Effect Clinical Trial

— METRO  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350021
• Other study ID #: 2018-09-20 Version 1.2
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer Metastatic
• Breast Neoplasms
• Chemotherapy Effect

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.