Breast Cancer
Conditions
Keywords
Locally advanced or metastatic breast cancer, Estrogen receptor positive [ER(+)], Progesterone receptor positive [PR(+)], Hormone receptor positive [HR(+)], Human epidermal growth factor receptor 2 negative [HER2(-)], ER(+)/HER2(-), PR(+)/HER2(-), HR(+)/HER2(-), Advanced Breast Cancer, Breast tumor, Breast cancer, Palbociclib, Abemaciclib, Ribociclib, Partial Response+ (PR+), Metastatic breast cancer, Hormone Therapy, Hormone positive breast cancer, Recurrent breast cancer, HR+, HER2-negative, Relapse, Recurrent, First line treatment, Left Sided Breast Cancer, Left-Sided Breast Cancer, Right Sided Breast Cancer, Right-Sided Breast Cancer, Unilateral Breast Cancer, Cancer of the breast, CDK4i, CDK4/6i, Bilateral Breast Cancer
Brief 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.
Interventions
DRUGPF-07220060
CDK4 inhibitor
DRUGletrozole
endocrine therapy
DRUGabemaciclib
CDK4/6 inhibitor
DRUGpalbociclib
CDK4/6 inhibitor
DRUGribociclib
CDK4/6 inhibitor
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study participants will be randomly assigned into 1 of 2 groups in parallel for the entire duration of the study. The experimental arm will receive PF-07220060 and letrozole (Arm A) while the comparator arm with receive the study doctors choice of CDK4/6i and letrozole (Arm B).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) by BICR | From the date of randomization until disease progression or death due to any cause (up to approximately 4 years) | Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From the date of randomization until death due to any cause (up to approximately 13 years). | Time from the date of randomization to the date of death due to any cause |
| Progression Free Survival (PFS) by Investigator | From the date of randomization until disease progression or death due to any cause (up to approximately 4 years) | Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by investigator per RECIST v1.1, or death due to any cause, whichever occurs first |
| OR by BICR and by investigator | From randomization to progression or death whichever occurs first (up to approximately 4 years) | Time from randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death whichever occurs first |
| Duration of Response (DoR) by BICR and by investigator | From the date of CR or PR until objective progressive disease, or death (up to approximately 4 years) | Time from the date of CR or PR to the first documentation of objective progressive disease, or death due to any cause, whichever occurs first |
| Incidence of treatment emergent treatment related adverse events (AE) | Duration of the study approximately up to 13 years. | Incidence and severity of AEs graded according to the NCI CTCAE v5.0 |
| Incidence of treatment emergent treatment related serious adverse events | Duration of the study approximately up to 13 years. | Incidence and severity of AEs graded according to NCI CTCAE v5.0 |
| Estimated mean change from baseline in EORTC QLQ C30 | Baseline to end of treatment (up to approximately 4 years) | — |
| Estimated mean change from baseline in BPI-SF | Baseline to end of treatment (up to approximately 4 years) | — |
| Estimated mean change from baseline in EQ-5D-5L | Baseline to end of treatment (up to approximately 4 years) | — |
| Estimated mean change from baseline in EORTC Breast Cancer Module (BR42) | Baseline to end of treatment (up to approximately 4 years) | — |
| Mean change from baseline of ctDNA | Baseline to end of treatment (up to approximately 4 years) | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Netherlands, Poland, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed