Breast Cancer MetastaticMETRONCT04350021
Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer
An observational study of Breast Cancer Metastatic and Chemotherapy Effect, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic, Chemotherapy Effect
- What is being tested?
- Capecitabine, Cyclophosphamide
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2019to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Metastatic breast cancer
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 405 83
About this study
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
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.
- Conditions
- Breast Cancer Metastatic, Chemotherapy Effect
- Being tested
- Capecitabine, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, CyclophosphamideDrug
Capecitabine 500 mg times three, Cyclophosphamide 50 mg once daily
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rates
Radiological and Clinical evaluation
Measured: 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
Measured: 24 weeks
Secondary outcomes (7)
Progression free survival
Radiological and Clinical evaluation
Measured: From baseline until three months after last dose.
Overall survival
Death
Measured: From baseline until death of any course assesed up to one year.
Tolerance and safety assessment
Clinical evaluation
Measured: From baseline until three months after last dose.
Health-related quality of life
EORTC-QLQ (Quality of Life Questionnaire)-30
Measured: From baseline until three months after last dose.
Evaluation of molecular characteristics in ctDNA (circulating tumor) defined as mutational changes.
Blood sample
Measured: 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
Measured: 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
Measured: From baseline until the date of first documented progression or date of death from any cause, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Mar 2019
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350021
- Sponsor's protocol ID
- 2018-09-20 Version 1.2
- Acronym
- METRO
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2019
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11863115Masuda 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.
PubMed 28564564Dellapasqua 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.
PubMed 18794539
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04350021
- Acronym / sponsor ID
- METRO / 2018-09-20 Version 1.2
- Conditions
- Breast Cancer Metastatic, Chemotherapy Effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Metastatic breast cancer
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine, CyclophosphamideCapecitabine 500 mg times three, Cyclophosphamide 50 mg once daily | Drug | – |
Primary outcome
Overall response rates
Time frame: From baseline until three months after last dose.
Radiological and Clinical evaluation
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.
Time frame: 24 weeks
Complete response and Partial response
7 secondary outcomes
Progression free survival
Time frame: From baseline until three months after last dose.
Overall survival
Time frame: From baseline until death of any course assesed up to one year.
Tolerance and safety assessment
Time frame: From baseline until three months after last dose.
Health-related quality of life
Time frame: From baseline until three months after last dose.
Evaluation of molecular characteristics in ctDNA (circulating tumor) defined as mutational changes.
Time frame: 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
Time frame: 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
Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 11863115Colleoni 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.
- Background: PubMed 28564564Masuda 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.
- Background: PubMed 18794539Dellapasqua 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Metastatic and Chemotherapy Effect, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rates (time frame: From baseline until three months after last dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04350021, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.