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A randomised, double-blind, parallel group, equivalence, multicentre phase III trial to compare the efficacy, safety and pharmacokinetics of HD201 to
Herceptin® in patients with HER2+ early breast cancer.

The primary objective of this study is to show equivalence of the total pathological complete response rate (tpCR) in patients treated withHD201 plus chemotherapy to that in patients treated with Herceptin® plus chemotherapy. tpCR will be assessed…

Explorative trial to identify the impact of denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal patients with HER2 negative breast cancer.

Primary objective• Determine the change in intratumoral T-cell (CD4, CD8 and Treg) and Myeloid cell (M1/M2 Macrophage, MDSC, DC) numbers and function between the baseline biopsy and the surgical specimen.Secondary objectives• PBMC before start…

A randomized controlled trial testing hyaluronic acid spacer injection for skin toxicity reduction of Permanent Breast Seed Implant (PBSI)

The primary objective is to evaluate and report the effect of an injected hyaluronic acid spacer on the rate of telangiectasia following PBSI.

A PHASE III, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY OF TASELISIB PLUS FULVESTRANT VERSUS PLACEBO PLUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR POSITIVE AND HER2 NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE DISEASE RECURRRENCE OR PROGRESSION DURING OR AFTER AROMATASE INHIBITOR THERAPY

To evaluate the efficacy, safety, pharmacology, and patient-reported outcomes of the combination of taselisib plus fulvestrant compared to placebo plus fulvestrant in ER+, HER2- postmenopausal women with locally advanced or MBC and who have had…

A phase II randomized, double-blind placebo controlled, study of letrozole with or without BYL719 or
buparlisib, for the neoadjuvant treatment of postmenopausal women with hormone receptor-positive
HER2-negative breast cancer (CBYL719A2201)

Primary objective: Determine whether treatment with a PI3K inhibitor (BYL719 or buparlisib) plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with hormone receptor-positive HER2-…

*An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer*

Primary:The primary objective of this study is to demonstrate that the overall progression-free survival (PFS) of 8 cycles of intermittent (2 times 4 cycles) chemotherapy (paclitaxel) is not inferior in efficacy, compared to 8 continuous cycles of…

Three-Dimensional Ultrasound Volume Ratio for Improving Cosmetic Results in Breast Cancer Patients; TURACOS trial

The value of implementation and cost-efficacy of Tumor Volume / Breast Volume Ratio, as measured by Automated Breast Volume Scanner (ABVS), during the preoperative workup in breast cancer patients on 1) cosmetic result after BCS, and 2) surgical…

Stimulation of the ovaries in women with breast cancer undergoing fertility preservation: alternative versus standard stimulation protocols; the STIM-trial

To evaluate the effects of COS with tamoxifen or letrozole compared to standard COS, on oocytes retrieved.

Phase I/II trial of S 81694 administered intravenously in;combination with paclitaxel to evaluate the safety,;pharmacokinetic and efficacy in metastatic breast cancer

The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in mBC patients, and to investigate the antitumour activity…

Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancer

The goal of the trial is to investigate the safety and efficacy of SAR566658, if it is provided to CA6 protein positive metastaticTBN breastcancer patients.

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician*s Choice for Metastatic Triple Negative Breast Cancer (mTNBC) * (KEYNOTE-119)

The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) compared to other chemotherapy drugs of physician*s choice (which includes Capecitabine, Eribulin, Gemcitabine…

Early detection of symptoms using digital patient-reported symptom monitoring and a Fitbit to optimize care in metastatic breast cancer (SYMPHA, BOOG 2024-01).

This study aims to determine the effect of real-time symptom monitoring on HRQoL in patients with mBC who start first-line chemo(immune)therapy. Further objectives include analyzing the effect of PRS monitoring on physical functioning, the severity…