Overview

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 B)

Status:
Not yet recruiting
Trial end date:
2027-06-15
Target enrollment:
0
Participant gender:
All
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. This study is seeking participants who have breast cancer that: - is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy - is sensitive to hormonal therapy (it is called estrogen receptor positive); and - is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study B: All participants will receive ARV-471 and a medicine called ribociclib. ARV-471 and ribociclib will be given at the same time by mouth, at home, 1 time a day. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective. Participants will continue to take ARV-471 and ribociclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Collaborator:
Arvinas Estrogen Receptor, Inc.
Criteria
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; only 1 line of any CDK4/6 inhibitor-based regimen is allowed

- 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