ASCENT-05

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
Description: This trial contains two study arms where participants will be randomised to one of two treatment arms in a 1:1 ratio. The first arm is a combination of the study drug, Sacituzumab- Govitecan (Sac-TMT) in combination with Pembrolizumab for 8 cycles. The second treatment arm would consist of the treatment of your physician's choice. This study is for patients with Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
Study Phase: Phase 3
Principal Investigator: Dr. Niamh Coleman
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Destiny-15

A Phase 3b, multicenter, global, interventional, open-label, study of Trastuzumab Deruxtecan (T-DXd), in patients who have unresectable and/or metastatic HER2-low or HER2 IHC breast cancer
Description: This trial contains 1 treatment arm- Trastuzumab Deruxtecan (T-DXd). Patients who have unresectable and/or metastatic breast cancer that is HER2-low or HER2 positive may be eligible
Study Phase: Phase 3
Principal Investigator: Dr Ciara O'Hanlon Brown
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Ember

A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
Description: This is a trial in early stage breast cancer enrolling patients that test positive for oestrogen receptors and negative for HER2 receptor. Patients will receive either standard therapy or Imlunestrant. Patients must have already received 2 to 5 yrs of standard hormone therapy
Study Phase: Phase 3
Principal Investigator: Ciara O'Hanlon Brown
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Fourlight-03 (C4391024)

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI-CANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE
Description: This is a large international clinical trial testing a new drug called PF-07220060, used together with letrozole, in people with a specific type of breast cancer. The goal is to see how well this new combination works compared to existing treatments.
Study Phase: Phase 3
Principal Investigator: Dr Niamh Coleman
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Shamrock

Single arm phase 2 trial of neoadjuvant trastuzumab deruxtecan (T-DXd) with response-directed definitive therapy in early stage HER2-positive breast cancer: a cytotoxic chemotherapy-sparing approach to curative-intent treatment
Description: This trial will assess the effectiveness of trastuzumab deruxtecan (T-DXd) given in the neo-adjuvant setting (i.e before surgery) in women with HER2+ve breast cancer
Study Phase: Phase 3
Principal Investigator: Dr Ciara O'Hanlon Brown
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TREAT ctDNA

Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA)
Description: This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse. During the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood. Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.
Study Phase: Phase 3
Principal Investigator: Dr Ciara O'Hanlon Brown
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