Breast Cancer Clinical Trial

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 A)

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 A:

All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.

Participants will continue to take ARV-471 and abemaciclib 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.

View Full Description

Full Description

C4891006 is a sub-study from the Umbrella platform, TACTIVE-U, comprising multiple sub-studies that independently evaluate ARV-471 in participants with Estrogen Receptor Positive (ER+) Advanced or Metastatic Breast Cancer (A/MBC). ARV-471 will act as the backbone therapy given in combination with other anticancer agents thought to have clinical relevance in ER+ breast cancer.

View Eligibility Criteria

Eligibility 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; 1 line of any CDK4/6 inhibitor-based regimen is required (independent of the setting eg, adjuvant or advanced/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 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT05548127

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 8 Locations for this study

See Locations Near You

Siteman Cancer Center - WUPI
Shiloh Illinois, 62269, United States
Siteman Cancer Center - West County
Creve Coeur Missouri, 63141, United States
Siteman Cancer Center - North County
Florissant Missouri, 63031, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Washington University
Saint Louis Missouri, 63110, United States
Siteman Cancer Center - South County
Saint Louis Missouri, 63129, United States
Siteman Cancer Center - St Peters
Saint Peters Missouri, 63376, United States
The Ottawa Hospital - General Campus
Ottawa Ontario, K1H 8, Canada
Sunnybrook Research Institute - Odette Cancer Centre
Toronto Ontario, M4N 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT05548127

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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