Search for a trial

Rapid Access to Contrast-Enhanced spectral mammogRaphy (RACER): a more efficient work-up of women recalled from breast cancer screening

The RACER project studies a more efficient approach based on (rapid access to) CESM, primarily resulting in less follow-up exams due to the superior specificity of CESM over FFDM. In addition, otherwise occult cancers will be detected in the women…

Biomarker discovery randomized phase IIb trial with carboplatin-cyclophosphamide versus paclitaxel with or without Bevacizumab as first-line treatment in advanced triple negative Breast cancer (TRIPLE-B study);Title after protocol amendment August 12, 2017:
Biomarker discovery randomized phase IIb trial with carboplatin-cyclophosphamide versus paclitaxel with or without atezolizumaB as first-line treatment in advanced triple negative Breast cancer (TRIPLE-B study)

This study has been transitioned to CTIS with ID 2024-516202-39-00 check the CTIS register for the current data. Modified objectives after implementation of protocol amendment Sept 2024: Primary: 1. Validate the BRCA1-like test* in predicting…

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…

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (FASLODEX) with or without PD-0332991 (PALBOCICLIB) ± Goserelin in Women with Hormone Receptor-Positive, Her2-Negative Metastatic Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy

Primary Objective:- To demonstrate the superiority of palbociclib in combination with fulvestrant (with or without goserelin) over fulvestrant alone (with or without goserelin) in prolonging investigator-assessed PFS in women with HR+/HER2-negative…

EPIK-B2: A two part, Phase III, multicenter, randomized (1:1), double blind, plaebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation.

Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens

Primary Objective:• To assess and compare efficacy of sacituzumab govitecan to TPC as measured by progression free survival (PFS) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1…

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) versus Investigator*s Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

This study has been transitioned to CTIS with ID 2024-516653-44-00 check the CTIS register for the current data. The primary purpose of the study is to determine the efficacy and safety of T-DXd compared with investigator*s choice single agent…

Protein and calorie restriction as treatment for prevention of cardiotoxicity in women receiving chemotherapy.

To investigate the effects of a 5-day diet with 30% caloric and 70% protein restriction on cardiotoxicity induced by anthracycline treatment in women with triple negative or hormone receptor-positive breast cancer. The biomarker high-sensitivity…

The effect of hilotherapy on chemotherapy-induced peripheral neuropathy in the treatment of breast cancer with Paclitaxel.

Investigate the effect of hilotherapy on the severity of CIPN and nail toxicity, and its influence on treatment management and quality of life in patients with breast cancer during, and three and six months after treatment with Paclitaxel.

A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo
versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary
breast cancer

The primary objective is to compare invasive disease-free survival (IDFS) in patients with HER2-positive breast cancer randomized to chemotherapy plus one year of trastuzumab plus placebo or chemotherapy plus one year of trastuzumab plus pertuzumab…

A multi-centre, open-label, randomized clinical trial comparing the efficacy and safety of the antibody-drug conjugate SYD985 to physician's choice in patients with HER2-positive unresectable locally advanced or metastatic breast cancer

The primary objective of this study is to demonstrate that SYD985 is superior to physician*s choice in prolonging progression-free survival (PFS) on the basis of the blinded independent central review of tumour assessment.The secondary objectives of…

A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2 NEGATIVE EARLY BREAST CANCER

This study has been transitioned to CTIS with ID 2023-507172-44-00 check the CTIS register for the current data. To demonstrate superiority of giredestrant over the control treatment in preventing breast cancer recurrence.Secondary objectives• To…

Pre- versus Postoperative Accelerated Partial Breast Irradiation in early stage breast cancer patients

To assess the cosmetic effect of preoperative versus postoperative partial breast irradiation (prePBI vs postPBI)

The effect of yoga on endocrine therapy induced musculoskeletal symptoms in women with breast cancer

The objective of the proposed study is to assess the effectiveness of a 4-month yoga program compared to a waiting list control group on musculoskeletal complaints in women with hormone-positive stage I-III breast cancer receiving endocrine…

Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy (SUBITO) an international randomized phase III trial

This study has been transitioned to CTIS with ID 2024-516196-32-00 check the CTIS register for the current data. To investigate whether (neo)adjuvant systemic treatment of intensified alkylating chemotherapy with peripheral stem cell rescue (mini-…

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High-Risk, Node-Positive, Early -Stage, Hormone Receptor-Positive, Human Epidermal Receptor 2-Negative, Breast Cancer

This study has been transitioned to CTIS with ID 2023-509671-17-00 check the CTIS register for the current data. The primary objective is To evaluate the efficacy, in terms of invasive disease-free survival (IDFS), as defined by the STEEP System,…

SUPREMO (Selective Use of Postoperative Radiotherapy AftEr
MastectOmy). A phase III randomised trial to assess the role of adjuvant chest wall irradiation in *intermediate risk* operable breast cancer following mastectomy.

Primary objective: To determine whether there is an overall survival benefit for patients with an intermediate risk breast cancer from chest wall irradiation following mastectomy, in addition to treatment with optimal modern systemic therapy.…

A randomized, multicenter, double-blind phase 3 study of amcenestrant (SAR439859) plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced disease

The primary objective of this study is to determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) compared to letrozole in combination with palbociclib in patients with ER +, HER2-advanced breast cancer…

Tailoring neoadjuvant therapy in hormone receptor positive, HER2 negative, luminal breast cancer.

Primary objective:• Determine if ribociclib plus letrozole gives a >=100% improvement in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) as compared to chemotherapy in the surgical specimen*.Secondary objective• Study the…

AIPAC (Active Immunotherapy PAClitaxel): A multicentre, Phase IIb, randomised, double blind, placebo-controlled study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel.

Primary objectives:* Safety run-in stage: determine the recommended phase two dose for therandomised phase* Randomised stage: to determine efficacy of IMP321 combined with weekly paclitaxel compared to weekly paclitaxel plus placebo in hormone…