TACTIVE-U: An Umbrella Study to Investigate the Safety and Antitumor Activity of Vepdegestrant (ARV-471) in Combination With Other Medicines in Adults With ER+ Advanced or Metastatic Breast Cancer, Sub-study A (ARV-471 and Abemaciclib)

Phase 1

Recruiting

• Conditions: ER +/HER2- Advanced or Metastatic Breast Cancer; MedDRA version: 21.1Level: LLTClassification code: 10072737Term: Advanced breast cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502228-34-00
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening, Histological or cytological diagnosis of ER+ and HER2- A/MBC 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. - One, and only 1 line of any prior CDK4/6 inhibitor-based regimen is required (independent of the setting eg, adjuvant or advanced/metastatic). If prior CDK4/6 inhibitor was permanently discontinued due to an adverse event, the participant will not be eligible., Participants must have at least 1 measurable lesion as defined by RECIST v1.1, Eastern Cooperative Oncology Group (ECOG) performance status ( PS) =1.

Exclusion Criteria

Participants in visceral crisis at risk of life-threatening complications in the short term., Participants with a known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions., Participants with newly diagnosed brain metastases, or symptomatic central nervous system (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., History of any other 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. All other malignancies must have been curatively treated and with no evidence of disease for >3 years. Participants with inflammatory breast cancer are excluded., 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 including hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified