Study Details

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C4391024: "AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTATIC DISEASE (FOURLIGHT-3)"

The purpose of this study is to compare the effects of the study drug PF-07220060 plus letrozole on your body with a comparison drug (palbociclib, ribociclib, or abemaciclib) plus letrozole, to find out which is better for treating your type of breast cancer. The study drug is an investigational drug because it is not approved for use in breast cancer treatment. The comparison drug is already approved to treat HR+, HER2- advanced or metastatic breast cancer. Researchers will compare the results of taking the comparison drug (palbociclib, ribociclib, or abemaciclib) plus letrozole to the results of taking the study drug plus letrozole to see if there are any differences.

Age & Gender

18 years ~ 99 years
Male, Female

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

After you sign this consent document, the study will start with a screening visit. This is to learn about your medical history and to check if you meet the study requirements. Many of the screening tests and procedures are part of regular cancer care and may be done even if you do not join the study. Assessments/results which were obtained as part of your medical care before this consent was signed (e.g., tumor biopsy, scans [CT scans, MRIs or whole-body scans]) may be provided to the Sponsor, or third-party vendor of the Sponsor's, and used to evaluate eligibility for the study.

Incentives

You will be paid $75.00 dollars for each on-site study visit you complete and $39.00 dollars for each phone visit you complete. You will be paid $20.00 dollars for at least 95% completion of the Dosing Diary through dosing duration, per cycle. If you leave the study early for any reason, you will be paid for activities already completed.

Total length of participation:
Stie visits are apprx every 15 days for the first 2 months then apprx every 28 days after whiile receiving study drug.

Looking for Specific Volunteers

Able to participate:

18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening.
Histological confirmation of BC with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease. Note: Patients who have received ≤2 weeks of NSAI in thisP
Resolution of acute effects of any prior therapy to no worse than CTCAE Grade 1 (except for AEs not constituting a safety risk in the
Participants must have either measurable disease or non-measurable bone only disease. Measurable and non-measurable disease are defined by RECIST v1.1. Tumor lesions previously irradiated or

Not eligible if:

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study
Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in
Known or suspected hypersensitivity to active ingredient/excipients of PF-07220060 or other study interventions.
Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and peritoneal), pulmonary
Current or past history of CNS metastases

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Stephen Kimani
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

24-3176