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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Epik B5

A Phase III, randomized, double-blind, placebo-controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation, who progressed on or after aromatase inhibitor and a CDK4/6 inhibitor
Description: This study will assess the efficacy of alpelisib plus fulvestrant in participants with Hormone receptor-positive, HER2-negative, advanced breast cancer after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
Study Phase: Phase 3
Principal Investigator: Dr Ciara O'Hanlon Brown
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PreCOOPera (IBCSG 67-22)

A Window-of-Opportunity trial of giredestrant +/- triptorelin vs. anastrozole + triptorelin in premenopausal patients with ER-positive/HER2-negative early breast cancer
Description: PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C).
Study Phase: Other
Principal Investigator: Dr Ciara O'Hanlon Brown
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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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