Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Haukeland University Hospital
With
Helse Vest
Pfizer
AstraZeneca
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Previously untreated, histologically confirmed non-inflammatory breast cancer, \>4 cm in diameter and /or metastatic ipsilateral axillary deposits for which the smallest diameter of the largest node \>2 cm by CT or ultrasound scan.
WHO performance status 0-1
Known tumor ER, PGR, HER2 and TP53 status.
Known tumor Ki67 percentage (if ER/PGR\>50% and TP53 wt status).
Distant metastasis not suspected. Patients will undergo radiology exams during screening phase, after signing the informed consent.
Age \>18 years
Patients must have clinically and/or radiographically documented measurable breast cancer according to RECIST.
Radiology studies (CT thorax/abdomen and bone scintigraphy/bone scan) must be performed within 28 days prior to registration.
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Before patient registration/randomization, written informed consent must be given according to national and local regulations.
For arms B-H:
* Neutrophils \> 1.5 x 109/L
* Platelets \> 100 x 109/L
* Bilirubin \< 2 x upper limit normal (ULN). For patients with Gilbert´s syndrome bilirubin \>2 x ULN is accepted if there is no evidence of biliary obstruction.
* Serum creatinine \< 1.5 x ULN
* ALT and Alk Phos (ALP) \<2.5 x ULN
* INR \< 1.5
You may not be if
Unstable angina pectoris or heart failure
Other co-morbidity that, based on the assessment of the treating physician, may preclude the use of chemotherapy at actual doses.
Pregnant or lactating patients can not be included.
Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.
Active cystitis (to be treated upfront)
Active bacterial infections
Urinary obstruction
Clareo Health | PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial
