TITRE (EN) An interventional safety and efficacy phase 1b/2, open-label umbrella study to investigate tolerability, pk, and antitumor activity of ARV-471 (PF-07850327), an oral proteolysis targeting chimera, in combination with other anticancer treatments in participants aged 18 years and over with ER+ advanced or metastatic breast cancer, sub-study B (ARV-471 in combination with ribociclib)
PROTOCOLE ID TACTIVE-U
CLINICAL TRIAL.gov ID NCT05573555
TYPE(S) DE CANCER Sein
PHASE Phase I-II
TYPE D'ÉTUDE Clinique
INSTITUTION CSSS DE CHICOUTIMI
305, rue Saint-Vallier G7H 5H6
VILLE Chicoutimi
INVESTIGATEUR(RICE) PRINCIPAL(E) José Luiz Miranda Guimaraes
COORDONATEUR(RICE) Alexandra Simard
418-541-1000 poste 3163
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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 (in any setting eg adjuvant, metastatic)
  • at least 1 measurable lesion as defined by RECIST v1.1.
  • ECOG PS ≤1.
CRITÈRES D'EXCLUSION (EN)
  • 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 of 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