Trial details
TACTIVE-U: 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)
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Trial short name: TACTIVE RIBO
Official title: TACTIVE-U: 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)
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: Ribociclib
Registration #:
NCT05573555 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
C4891023 is a prospective, open-label, multicenter, Phase 1b/2 sub-study to evaluate the safety, antitumor activity, and PK of ARV-471 with ribociclib in the treatment of participants with A/MBC. The sub-study is part of Umbrella platform, TACTIVE-U, comprising multiple sub-studies that independently evaluate ARV-471 in participants with with Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Advanced or Metastatic Breast Cancer. 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: at least 1 and no more than 2 lines of prior therapies for advanced/metastatic disease; 1, and only 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. 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 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
