Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer

NCT ID: NCT04350021

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Metastatic Chemotherapy Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Capecitabine, Cyclophosphamide

Capecitabine 500 mg times three, Cyclophosphamide 50 mg once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 11863115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28564564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18794539 (View on PubMed)

Other Identifiers

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2018-09-20 Version 1.2

Identifier Type: -

Identifier Source: org_study_id

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