Clinical trial NCT04350021: Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Metastatic
Chemotherapy Effect
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2020-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic breast cancer

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall response rates
timeFrame: From baseline until three months after last dose.
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
measure: Progression free survival
timeFrame: From baseline until three months after last dose.
measure: Overall survival
timeFrame: From baseline until death of any course assesed up to one year.
measure: Tolerance and safety assessment
timeFrame: From baseline until three months after last dose.
measure: Health-related quality of life
timeFrame: From baseline until three months after last dose.
measure: Evaluation of molecular characteristics in ctDNA (circulating tumor) defined as mutational changes.
timeFrame: From baseline until the date of first documented progression or date of death from any cause, whichever came first.
measure: Evaluation of CA (cancer associated antigen) 15-3 in relation to treatment effect
timeFrame: From baseline until the date of first documented progression or date of death from any cause, whichever came first.
measure: Evaluation of immune deficiency panel markers defined as changes in immune cell composition
timeFrame: From baseline until the date of first documented progression or date of death from any cause, whichever came first.
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
state: Vastra Gotaland
Study officials:
References:
citation: 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.
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.
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.