PErsonalized TREatment of high-risk MAmmary Cancer – the PETREMAC Trial. Positive Trial. NBCG15, PI: Hans Petter Eikesdal.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unstable angina pectoris or heart failure
- 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.
Contact information: Hans Petter Eikesdal, hans.petter.eikesdal(a)helse-bergen.no
NBCG 