A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a
chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb)
receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and
cyclophosphamide (TAC). Chemotherapy affects cells that are dividing, whether they are tumor
cells or healthy cells (including, bone marrow cells, hair follicle cells, and epithelial
cells lining the gastrointestinal tract). ALRN-6924 is designed to stop cell division in
healthy cells but not in tumor cells because they have a mutation of the TP53 gene. When this
happens, tumor cells will still be destroyed by the chemotherapy but healthy cells that are
not dividing may be spared from chemotherapy damage and the patient should have less side
effects.