Clinical Trial 22199-B

• Overview

  Study Title:

  Pfizer Umbrella Study - 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)

  Summary:

  The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer.

  Objective:

  Objectives To assess safety and tolerability of ARV-471 in combination with ribociclib in participants with ER+/HER2- A/MBC, to select a RP2D. To evaluate the overall safety profile. To evaluate antitumor activity of ARV-471 in combination with ribociclib. To evaluate the effect of ribociclib on PK ofARV-471

• Treatments

  Therapies:

  Chemotherapy (NOS)

  Medications:

  ARV-471 (); LEE011 (Ribociclib); Ribociclib ()

• 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 (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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.