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

15/30

TailorDose II. TailorDose®-II: Therapeutic dose monitoring of commonly used cytostatic drugs/regimes indicated for breast cancer

3

2017-06-15

Oscar Wiklander

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

2021-12-07

Theodoros Foukakis

21/062

CARDIOCARE. CARDIOCARE: AN INTERDISCIPLINARY APPROACH FOR THE MANAGEMENT OF THE ELDERLY MULTIMORBID PATIENT WITH BREAST CANCER THERAPY INDUCED CARDIAC TOXICITY

Ej tillämpbar

2023-12-19

Andri Papakonstantinou

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

23/012

PIPN. Paclitaxel-induced polyneuropathy in breast cancer: early detection, risk factors, quality of life and lifestyle outcomes

Ej tillämpbar

2024-01-22

Theodoros Foukakis

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

24/022

Trofuse MK2870-010. 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

2025-02-20

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

2025-01-30

Theodoros Foukakis

24/057

C4391025 (FourLight-2). An Interventional, Open-Label, Randomized, Multicenter Phase 2 Study of PF- 07220060 Plus Letrozole Compared to Letrozole Alone in Postmenopausal Women 18 Years or Older with Hormone Receptor-Positive, HER2-Negative Breast Cancer in the Neoadjuvant Setting

2

2025-02-14

Theo Foukakis

Endokrina tumörer och sarkom

 Nr Namn

Fas

Startdatum Ansvarig prövare

20/052

Parafys. Primär hyperparathyroidism hos äldre – fysisk träning för att förbättra muskelfunktion, balans och kognitiv förmåga

Ej tillämpbar

2020-09-01

Inga-Lena Nilsson

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

2023-11-30

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

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 05.07.2025