Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Ha… (NCT06760637) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
United States, Argentina, Australia1,035 participantsStarted 2025-01-06
Plain-language summary
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer:
* HR-positive (breast cancer cells that need estrogen or progesterone to grow)
* HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface);
* locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body)
* who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease.
Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator's choice of treatment plus letrozole.
The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial combining PF-07220060 with letrozole as a first-line treatment — does that mean this would replace what you'd otherwise recommend as my first treatment for advanced or metastatic HR-positive, HER2-negative breast cancer, and how does that affect my options going forward?
2The trial is active but no longer enrolling new participants — is there any chance I could still access PF-07220060, either through a compassionate use program, expanded access, or another study that might be open?
3Since the main thing this trial is measuring is how long people go without their cancer progressing (progression-free survival), what does that mean for understanding whether this combination might help me live longer overall, and is that data available yet?
4PF-07220060 is a newer drug being tested alongside letrozole — based on what's known so far about its side effect profile, are there any safety signals you'd want me to be aware of compared to standard CDK4/6 inhibitor combinations I might otherwise receive?
5Given that I haven't started any treatment yet for my advanced disease, would you recommend I consider a currently available standard regimen first, or does the data from this trial make it worth waiting to see if a similar study opens up?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS) by BICR
Timeframe: From the date of randomization until disease progression or death due to any cause (up to approximately 4 years)