Trial details
TACTIVE-U: A Study to Learn About the Study Medicine (Called ARV-471) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: TACTIVE ABEMA
Official title: TACTIVE-U: A Study to Learn About the Study Medicine (Called ARV-471) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)
Principal Investigator: Dr. Katarzyna Jerzak
Cancer type: Breast
Cancer location: Breast
Disease stage: Early Cancer
Trial phase: Phase 1, Phase 2
Intervention: Drug: ARV-471 Drug: Abemaciclib
Registration #:
NCT05548127 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
C4891006 is a sub-study from the Umbrella platform, TACTIVE-U, comprising multiple sub-studies that independently evaluate ARV-471 in participants with Estrogen Receptor Positive (ER+) Advanced or Metastatic Breast Cancer (A/MBC). ARV-471 will act as the backbone therapy given in combination with other anticancer agents thought to have clinical relevance in ER+ breast cancer.
Inclusion Criteria: • histological or cytological diagnosis of ER+ and HER2- advanced/metastatic breast cancer that is not amendable to surgical resection with curative intent (≥1% ER+ stained cells on the most recent tumor biopsy). • prior anticancer therapies: up to 2 lines of prior therapies for advanced/metastatic disease; 1 line of any CDK4/6 inhibitor-based regimen is required (independent of the setting eg, adjuvant or advanced/metastatic) • at least 1 measurable lesion as defined by RECIST v1.1. • ECOG PS <=1. Exclusion Criteria: • visceral crisis at risk of life-threatening complications in the short term • known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions. • newly diagnosed brain metastases, or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated, clinically stable and discontinued anti-seizure medications and corticosteroids for at least 14 days prior to enrollment in the study. • history of any other tumor malignancies within the past 3 years, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated in situ carcinoma of the cervix. • inflammatory breast cancer • impaired cardiovascular function or clinically significant cardiovascular diseases • concurrent administration of medications, food, or herb supplements that are strong inhibitors and strong/moderate inducers of CYP3A and drugs known to predispose to Torsade de Pointes or QT interval prolongation. • renal impairment, not adequate liver function and/or bone marrow function • known active infection
