Clinical studies

Breast cancer and p53 mutations: Chemotherapy with cyclophosphamide

The p53 breast-study is a clinical trial where patients with breast cancer are given a specific chemotherapeutic drug called cyclophosphamide. We study whether mutations in the TP53 gene or other important genes in the tumour are crucial to response to the therapy or not. The goal is to include 190 patients in this study.

The study is a collaboration between the cancer departments at Haukeland University Hospital (HUS, Bergen) (leads the study) and at the University Hospital of North Norway (UNN, Tromsø), St. Olavs Hospital (Trondheim), Stavanger universitetssykehus (SUS) and Akershus universitetssykehus (Ahus, Lørenskog).

Sequential chemotherapy prior to surgery in localized soft tissue sarcoma 

The goal of this study is to evaluate the effect and safety of sequential treatment with iphosphamide and doxorubicine prior to surgery in patients with soft tissue sarcoma without metastases and a with a high risk of relapse. The goal is to include 49 patients in this study.

This study is a collaboration between Oslo University Hospital (OUS) and Haukeland University Hospital (HUS, Bergen).

IMPRESS Norway: Implementation of personalized medicine in Norway

Personalized cancer treatment means that we use the characteristics of the cancer cells/tumours in individual patients to treat as precisely as possible. In this way, we aim to achieve an efficient treatment with few side effects.

This study is a national collaboration study lead by Oslo University Hospital (OUS).

Breast cancer PETREMAC: Personalized treatment

The PETREMAC-trial is a study of personalized treatment for patients with locally advanced breast cancer. The aim of the study is to identify mutations in the tumour that can predict resistance or sensitivity to specific therapies in individual patients.

The study was led by Haukeland University Hospital in Bergen and was a collaboration with the cancer departments at University Hospital of North Norway (UNN, Tromsø), St. Olavs Hospital (Trondheim), Helse Førde, Helse Fonna (Haugesund), Stavanger universitetssykehus (SUS) and Akershus universitetssykehus (Ahus, Lørenskog).

A total of 201 patients were included in this study, which ended patient recruitment in 2020.

In the PETREMAC-trial patients were divided into 8 treatment arms (A-H) based on TP53 mutation status and ER/PR/HER2 status in the tumour. The first data from patients with triple negative breast cancer in treatment arms G/H are now available and can be found here and in the table below. The table shows the number of patients with different clinical response in treatment arms G and H combined. 

*ORR: Proportion of patients who during the follow-up period obtained either a complete response (CR) or a partial response (PR).

Media coverage of the PETREMAC-trial (links and articles in Norwegian only):

• Bli med inn - PETREMAC-studien (YouTube (Haukeland universitetssjukehus), March 14, 2023)
• Norsk studie: Lynparza som monoterapi er lovende mot trippel negativ brystkreft (Brystkreft, June 26, 2022)
• Studie: Ny orsak till bröstcancer upptäckt (Expressen, June 12, 2022)
• La frem funn fra norsk-amerikansk studie om kreftrisiko (Dagens medisin, June 4, 2022)
• Studie: Ny årsak til brystkreft (Dagbladet, June 4, 2022)
• Hva er persontilpasset kreftbehandling? (Brystkreftforeningen, October 12, 2021)
• Åse vart kreftfri etter «umogeleg» behandling (NRK, April 15, 2021)
• Eli Karin slapp mye cellegift: – Jeg har levd som normalt og tenker ikke så mye på kreften. (BT, January 17, 2021)
• Aud og Kristel fikk ulik behandling for brystkreft. Én ble ufør, den andre føler seg helt frisk. (BT, November 5, 2020)
• Ett år etter marerittsommeren smiler Karina (BA, October 3, 2019)
• PETREMAC studien (Onkonytt, September 8, 2016)
• Forskere gir pionérbehandling til kvinner med aggressiv brystkreft (TV2, July 3, 2016)
• Vil skreddersy kreftbehandling slik at den virker for deg (TV2, June 18, 2016)
• Her går midlene fra Rosa sløyfe (BA, October 29, 2015)

Colorectal cancer: Chemotherapy with cyclophosphamide for patients with metastases from colorectal cancer and TP53 mutations

In this trial we aim to assess whether patients with metastases from colorectal cancer and mutations in the TP53 gene may have an effect from treatment with the chemotherapeutic drug cyclophosphamide.

The study was carried out at Haukeland University Hospital in Bergen. 

The study ended patient recruitment in 2020.

Predictors for response to dose-dense epirubicin and docetaxel breast cancer (DDP) 

The scientific aim of this study was to explore mechanisms of resistance to chemotherapy in breast cancer. To do so, we recorded molecular parameters in patients with large primary breast cancer who received treatment with dose-dense epirubicin followed by docetaxel, prior to surgery.

The study was carried out at Haukeland University Hospital in Bergen. 

A total of 109 patients were included in this study which ended patient recruitment in 2016.

Data from this study are available here and in the table below. The table shows the number of patients with different clinical response after treatment with the two drugs in this study. Response is shown both individually for each of the drugs but also combined after sequential treatment.

*ORR: Proportion of patients who during the follow-up period obtained either a complete response (CR) or a partial response (PR).

Evaluation of epirubicin versus paclitaxel for primary medical treatment (EPITAX)

In this study we aimed to evaluate and compare the clinical effects of optimal doses of epi-rubicin versus paclitaxel monotherapy, and to explore molecular mechanisms of resistance towards the two regimens in patients with locally advanced breast cancer.

The study was led by Haukeland University Hospital in Bergen and was a collaboration with the cancer departments at University Hospital of North Norway (UNN, Tromsø), St. Olavs Hospital (Trondheim), Stavanger universitetssykehus (SUS), Oslo universitetssykehus Ullevål (US, Ullevål) and Oslo universitetssykehus Radiumhospitalet (RH, Oslo).

A total of 223 patients with large breast tumours were included in this study which completed patient recruitment in 2003.

Data from this study are available in the table below. The table shows the number of patients with different clinical response in the two treatment arms in this study.

*ORR: Proportion of patients who during the follow-up period obtained either a complete response (CR) or a partial response (PR).