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PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial

Study acronym: PETREMAC
StatusActive, Not Recruiting
PhasePhase 2
Started2016-04-15
View on ClinicalTrials.gov ↗

Amendment history

2026-02-10
minor
Study Status v8
Re-verified, no change to tracked fields
2021-08-24
minor
Study Status, References v7
Publicationsdetails revised at 1 of 4 entries
2020-07-27
minor
Study Status v6
Primary completion dateestimated 2020-06→confirmed 2020-06-01
2018-10-04
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Start date2016-04→2016-04-15
Study sitesdetails revised at 7 of 7 sites
2017-11-02
minor
Study Status, Arms and Interventions, Eligibility v4
InterventionsAdjuvant Epirubicin+ Cyclophosphamide (Drug), Adjuvant letrozole (postmenopausal women) (Drug), Adjuvant palbociclib (if palbociclib given…→Adjuvant Epirubicin+ Cyclophosphamide (Drug), Adjuvant letrozole (postmenopausal women) (Drug), Adjuvant palbociclib (if palbociclib given…
Eligibility criteria+218 characters
[...] clusion Criteria: 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 [...] mply with study regulations as deemed by study investigator. Active cystitis (to be treated upfront) Active bacterial infections Urinary obstruction
Show 3 earlier versions
2017-06-23
minor
Study Status, Contacts/Locations v3
Study sitesdetails revised at 3 of 7 sites
2016-12-06
minor
Study Status, Outcome Measures, Contacts/Locations v2
Secondary endpointsdetails revised at 1 of 7 entries
Study sitesdetails revised at 2 of 7 sites
2016-04-18
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Recruiting
Start date2016-01→2016-04
Study sitesdetails revised at 7 of 7 sites
2015-12-04
minor
Original filing
Breast cancer is an optimal "model disease" for studying personalized medicine. Breast cancer was the first malignancy for which a predictive factor forecasting response to therapy was identified nearly 50 years ago; the expression of the estrogen receptor (ER). Furthermore, breast cancer is by far the malignancy in which prognostic and predictive factors have been most extensively studied. Primary medical treatment (pre-surgical medical therapy) offers a unique setting to explore predictive factors due to the fact that primary breast cancers are easily accessible to repeated tissue sampling and evaluation of therapy response both clinically and radiologically. For many years, the investigators have studied predictive factors in primary medical treatment of breast cancer. In the present project, the investigators will implement a new trial concept where the current knowledge from previous trials with respect to predictive markers (hormone receptors, HER2; TP53, CHEK2 and RB1), will be combined with massive parallel sequencing (MPS). Thereby, the investigators aim to design the "next-generation" primary medical treatment where 1) therapy regimens are individualized based on a limited number of known predictive factors and, 2) MPS is used to explore additional predictive factors and their co-regulators in order to fully identify the mechanisms of drug sensitivity / resistance across individual tumours and pave the way for further personalized breast cancer therapy in the future. As for the new era of "genomic medicine", the current trial concept will allow individual tumours to be characterized by their unique gene mutation / epigenetic modification profile upfront, to allocate patients to their optimal personalized medicine as compared to "classical" drug testing through phase II/III trials.
Trial Details
NCT Number NCT02624973
Lead Sponsor Haukeland University Hospital
Collaborators: Helse Vest, Pfizer, AstraZeneca
Conditions Breast Cancer
Enrollment 200 participants
Start Date 2016-04-15
Primary Completion 2020-06-01 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-12