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A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Letrozole in People Over 18 Years of Age With HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer who Have not Received any Prior Systemic Anticancer Treatment for Advanced/Metastatic Disease (FourLight-3)
EU CTIS ID: 2024-512925-95-00
What this study is testing
To compare the efficacy of PF-07220060 in combination with letrozole (Arm A) versus CDK4/6i (investigator’s choice: abemaciclib, palbociclib, or ribociclib) in combination with letrozole (Arm B) with respect to progression-free survival (PFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • At least 18 years of age (or the minimum age of consent in accordance with local regulations) at screening.
- • Pre/perimenopausal female and male participants must receive therapy with an LHRH agonist (LHRHa) prior to the first dose of study intervention (if not already ongoing) and continue throughout the study as outlined in the SoA.
- • Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- • Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
- • Documented HER2-negative tumor
- • Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease which is not amenable to curative treatment.
You likely can't join if
- • In visceral crisis at risk of immediately life-threatening complications in the short term.
- • Current or past history of central nervous system metastases.
- • Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
- • Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
- • Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
See the full eligibility criteria
- • At least 18 years of age (or the minimum age of consent in accordance with local regulations) at screening.
- • Pre/perimenopausal female and male participants must receive therapy with an LHRH agonist (LHRHa) prior to the first dose of study intervention (if not already ongoing) and continue throughout the study as outlined in the SoA.
- • Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- • Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
- • Documented HER2-negative tumor
- • Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease which is not amenable to curative treatment.
- • Participants must have either measurable disease or non-measurable bone-only disease per RECIST v1.1.
- • Participants must have an ECOG Performance Status of ≤2.
- • In visceral crisis at risk of immediately life-threatening complications in the short term.
- • Current or past history of central nervous system metastases.
- • Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
- • Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
- • Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Chile
- Argentina
- Mexico
- United States
- Canada
- Japan
- Brazil
- Turkey
- Taiwan
- United Kingdom
- Israel
- Switzerland
- Australia
- India
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Chile; Argentina; Mexico; United States; Canada and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.