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Evaluating the use of Magnetic Resonance Imaging and Contrast Enhanced Mammography after MagTrace® use

The primary objective in this trial is to evaluate the use of MRI and contrast enhanced mammography after using MagTrace® to perform a breast conserving surgery and a sentinel node biopsy.

T&T trial: adding Testosterone to Tamoxifen in male breast cancer patients

Primary Objective: To assess the safety profile (AEs, SAEs) on combined treatment with tamoxifen and testosterone.Secondary Objectives:• AR to ER ratio on baseline FES- and FDHT-PET imaging (assessed per lesion and per patient by quantitative…

Breast cancer Long-term Outcomes on Cardiac functioning: a longitudinal study

The aim of the here proposed study (BLOC-II) is to clarify whether cardiac function in survivors of BC should be monitored by GPs. We expect to clarify whether an unselected population of long-term BC survivors is at increased risk of developing…

Prehabilitation and rehabilitation in breast cancer surgery patients: a pilot study

The objectives of the BREHAB pilot study include both process and research objectives. Analysis of the process objectives will enable the feasibility of a larger RCT to be assessed. They focus on the feasibility of prehabilitation and rehabilitation…

COntinue the SaMe systemic therapy after local ablative therapy for Oligo progression in metastatic breast cancer - the COSMO study

The aim of this study is to find out how long the disease remains stable if we treat the 1-2 growing metastasis(s) locally by removing or irradiating/heating them, while continuing the treatment with your current drugs (anti-hormonal therapy,…

DESCARTES trial: De-ESCAlating RadioTherapy in patients with pathologic complete rESponse to neoadjuvant systemic therapy.

Primary aim: to assess whether local recurrence is acceptable when radiotherapy is omitted after breast conserving surgery in patients treated with NAC who achieve a pathologic complete response.Secondary aim: to assess quality of life and cancer…

Wireless Laser Speckle Contrast Imaging Device for the visualisation of the microcirculatory during DIEP flap breast reconstruction.

This study aims to demonstrate that the new generation of the HAPI, the Wireless Perfusion Imager (WIPI) is able to visualise the microcirculation of the abdominal flap and the newly reconstructed breast during DIEP flap breast reconstruction. The…

Indocyanine green guided identification of sentinel lymph nodes via mastectomy incision in breast cancer patients.

In this study, we aim to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLNBs via the mastectomy incision.

SEQUence of Endocrine therapy in advanced Luminal Breast cancer (SEQUEL-Breast)
A phase 2 study on fulvestrant beyond progression in combination with alpelisib for PIK3CA-mutated, hormone-receptor positive HER2 negative advanced breast cancer.

In the current phase 2 study we will investigate the efficacy of the combination of fulvestrant and alpelisib directly after progression on 1st or 2nd line therapy with fulvestrant with or without a CDK 4/6 inhibitor in patients with HR+HER2-…

Clinical evaluation of Contrast Enhanced Breast CT to improve Staging and treatment follow up in women with breast cancer

a. Staging of women with breast cancer, particularly those with extensive carcinoma in situ (DCIS):1) The concordance of tumor extent between CEBCT and large section histopathology2) The non-inferiority of CEBCT to contrast enhanced breast MRI for…

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors
Express PD-L1

This study has been transitioned to CTIS with ID 2023-504194-21-00 check the CTIS register for the current data. Primary Objective:- To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between…

Improving radical resection rates in patients with breast cancer by intraoperative imaging using bevacizumab-IRDye800CW - the MARGIN-2 study

Primary objectives -To determine whether real-time tumor visualization using targeted fluorescent imaging during breast conserving therapy in breast cancer patients can be achieved intraoperatively and results in adequate assessment of the tumor…

A randomized phase III trial of trastuzumab + ALpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced BrEasT cancer. *ALPHABET Study*

The study has been designed to demonstrate whether alpelisib in combination with trastuzumab (and fulvestrant in case of HR+) shows a higher clinical benefit compared with trastuzumab in combination with chemotherapy.Some of the secondary objectives…

Predicting an accurate tamoxifen dose: a feasibility study in patients with hormone positive breast cancer

The primary objective of this study is to determine the proportion of patients that reach an endoxifen level of 16 nmol/L or higher using MIPD. Secondary objectives: 1. To determine the total success rate of the POP-PK model as well as in different…

Single-dose preoperative partial breast irradiation in low-risk breast cancer patients

The goal of this study is to assess the efficacy of single dose preoperative radiotherapy in patients with low-risk breast cancer. In this context, efficacy is the proportion of patients achieving a pathologic complete response after single dose…

EvaLuating negAtive pressUre wound theRapy in brEast coNserving surgery - the LAUREN pilot study

The primary objective of this trial is to compare the number of postoperative wound complications in patients with and without negative pressure therapy after breast conserving surgery in the first three months after surgery. Wound complications…

Breast reconstruction and neoadjuvant radiotherapy, a changing algorithm.

The purpose of the pilot study is to assess acute post-surgical complications following mastectomy and immediate breast reconstruction after NART. We hypothesize that NART will avoid the negative effects of PMRT on the capsule of an implant, or on…

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician*s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1.

This study has been transitioned to CTIS with ID 2023-504195-14-00 check the CTIS register for the current data. •To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between sacituzumab govitecan (SG)…