A Phase 2/3 interventional study of Aspirin Low Dose and Placebo Oral Tablet in Breast Cancer, sponsored by Centro Hospitalar Lisboa Ocidental. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-09.
Sponsored by Centro Hospitalar Lisboa Ocidental · Phase 2/3, Interventional, and Treatment
Experimental, clinical, and epidemiological studies have all demonstrated the strong association between chronic inflammation and cancer, and many studies have correlated the prolonged presence of the inflammatory milieu with an increased risk for developing cancer.(1) Although the potential mechanism for aspirin preventing breast cancer is not known, possible pathways may involve platelets, inflammation, cyclooxygenase (COX) 2, hormones, or PI3 kinase. (2).
In actual clinical practice there exist clear guidelines for the use of aspirin in colorectal cancer but no such guidelines exist for the use of aspirin in breast cancer patients.
In the Unit´s proper experience, in patients under active surveillance and metastatic ones some present very good responses both in the neoadjuvant and in the metastatic setting but investigators intend to provide evidence and not just the experience. This study patients are proposed to combine their standard treatment with aspirin.
Breast cancer patients with diagnosis of Ductal or Lobular Invasive Carcinoma or CDis that refuse to underwent surgery or are not qualified for, and independently of age or of their actual staging, are going to be allocated, randomly and in double masked way to one of two arms:
Arm 1: standard Unit´s protocol + placebo Arm 2: standard Unit´s protocol + aspirin
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centro Hospitalar Lisboa Ocidental is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Every adult (above 18) y.o.patient with histologic diagnosis of Breast Cancer that refuse or is not suitable for surgical treatment, or with disease, remaining this way in an "active surveillance"
Exclusion Criteria:
Allergy or toxicity to aspirin
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1: standard Unit´s protocol + placebo
Drug: Placebo Oral Tablet
Arm 2: standard Unit´s protocol + aspirin
Drug: Aspirin Low Dose
Low-Dose Aspirin is to be added in the standard patient´s treatment
Placebo is to be added in the standard patient´s treatment
Overall Survival
Patients Overall survival in arm 2 superior to the arm 1
Time frame: 3 years
Metastatic Disease Stability
Metastatic disease stability (non progression) determined by imaging (ecography, CT,PET-CT or Bone Scintigraphy) in arm 2 superior to the arm 1
Time frame: 1 year
Tumor response till patient decides to exit the active surveillance
Tumor response till patient decides to exit the active surveillance
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Jun 2018; primary completion for Dec 2019, 18 months later.
Of 43 non-industry phase 2/3 interventional studies under Breast Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 91. This study's planned 18 months is below that.
Counting every sponsor, half of 56 studies reached it within 57 months; a quarter within 32 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Centro Hospitalar Lisboa Ocidental