Kliniska studier vid Tema Cancer

– Studier öppna för inklusion inom ME Bröst, Endokrin och Sarkom –

Här visas de studier som är öppna för patientinklusion inom den medicinska enheten (ME). Studierna är uppdelade på de olika patientflödena. Vidare visas ansvarig prövare, forskningssjuksköterska och planerad och aktuell inklusion inom temat (visas ej utanför Karolinska). Listan uppdateras minst en gång i veckan. -Längst ner finns en förklaring till de olika kolumnerna.

Bröstcancer

 Nr Namn

Fas

Startdatum Ansvarig prövare

21/021

CAPItello-292. A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer

1/3

2021-12-07

Theodoros Foukakis

22/013

Neo-ACT. Physical exercise during neoadjuvant chemotherapy for breast cancer as a means to increase pathological complete response rates: the randomized Neo-ACT trial

3

2022-11-18

Kristina Weibring

22/015

ARIADNE. A Randomized Trial on Biology-Driven De-escalation of Neoadjuvant Treatment for HER2-positive Breast Cancer

2

2023-07-18

Alexios Matikas

23/054

Taormina. Treatment of Oligometastatic breast cancer – a randomised phase 3 trial comparing stereotactic ablative radiotherapy and systemic treatment with systemic treatment alone as 1st line treatment

3

2024-01-17

Kristina Weibring

23/065

LION Trial and LION-COM. Demonstrating the (cost-)effectiveness of a personalized live-remote exercise intervention for cancer survivors using a super umbrella randomized clinical trial: The LION RCT

Ej tillämpbar

2024-10-10

Yvonne Wengström

24/022

MK2870-010 TroFuse-010. An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

3

2024-11-13

Alexios Matikas

24/026

TREAT ctDNA . Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA)

3

2025-03-12

Theodoros Foukakis

24/027

Destiny Breast Respond HER2-low Europe. A prospective, non-interventional study (NIS) with trastuzumab deruxtecan for patients with HER2-low expressing unresectable and/or metastatic breast cancer accompanied by a disease registry of patients treated with conventional chemotherapy

Ej tillämpbar

2025-10-30

Andri Papakonstantinou

24/042

HER2-Ex PET. A multicentre, prospective, open-label study to with [68Ga]Ga-ABY-025 PET-imaging to characterize HER2-expression and explore the therapy-predictive value for HER2-antibody drug conjugates in patients with metastatic breast cancer.

2

2025-06-04

Oscar Wiklander

24/073

iTRANSLATE-BREAST. Intergrate real-life platform for biomarker discovery and outcome-based translational research for breast cancer patients

Ej tillämpbar

2025-11-10

Andri Papakonstantinou

25/013

SentiNot 2.0. Use of superparamagnetic iron oxide (SPIO) tracer to avoid unnecessary sentinel node biopsies (SNB)

Ej tillämpbar

2025-09-25

Helena Sackey

25/039

MK2870-032. Randomized Phase 3 Open-label Active Controlled Study of Sacituzumab Tirumotecan (sac-TMT / MK-2870) in Early Triple Negative Breast Cancer (eTNBC

3

2025-11-25

Theodoros Foukakis

25/061

MK2870-012 TroFuse-012. A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surger

3

2025-11-28

Theo Foukakis

25/067

SentiNeo 2.0. Axillary lymph node localisation before neoadjuvant chemotherapy using MagTrace, (superparamagnetic iron oxide nanoparticles, SPIO) and Magseed, in clinically node negative and node positive patients: SENTINEO 2.0

Ej tillämpbar

2025-12-05

Helena Sackey

Endokrina tumörer och sarkom

 Nr Namn

Fas

Startdatum Ansvarig prövare

21/049

Kogni-Thyr-studien . Prospective longitudinal evaluation of objective cognitive function and quality of life in patients undergoing surgery for malignant and benign thyroid nodules Cognition and QoL in patients undergoing thyroid surgery

Ej tillämpbar

2022-01-03

Karin Lind

22/016

START-NET. Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors An open-label, multi-center, randomized phase III controlled trial comparing safety and efficacy of trial comparing safety and efficacy of personalized vs non-personalized personalized vs non-personalized radionuclide therapy with 177Lu-DOTATOC

3

2024-11-30

David Goldstein

23/058

ADIUVO-2. Adjuvant mitotane vs. mitotane with cisplatin/etoposide after primary surgical resection of localised adrenocortical carcinoma with high risk of recurrence (ADIUVO-2 Trial): A pragmatic, randomised, low-intervention phase III, clinical trial with an observational arm.

3

2024-10-16

David Goldstein

24/035

PERELI. A phase 2, open label study of PEmigatinib and REtifanlimab in advanced dedifferentiated LIposarcoma

2

2025-09-03

Andri Papakonstantinou

Övriga studier, flera diagnoser

 Nr Namn

Fas

Startdatum Ansvarig prövare

22/011

PREP. PREvention and Prediction of breast-and ovarian cancer - PREP

Ej tillämpbar

2022-08-01

Angelique Flöter Rådestad

23/025

TUBA-WISP II. Tubectomy with delayed oophorectomy as alternative for risk reducing salpingo-oophorectomy in BRCA-women to assess the safety of prevention

3-4

2024-01-01

Angelique Flöter Rådestad

Nr: Forskningsrådets nummer.
Namn: Studiens kortnamn följt av protokollets hela titel.
Fas: Kan vara Fas 1, 2, 3 eller Pilot, kombinationer av dessa, eller Ej tillämpligt.
Startdatum: Vanligen datum för startmöte eller liknande.
Ansvarig prövare: Den läkare som är ansvarig för studien inom Tema Cancer.
Ansvarig forskn.sköt: Den forskningssjuksköterska som är ansvarig.

CKC, Tema Cancer, Karolinska universitetssjukhuset 13.05.2026