A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment

NCT06105632
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
333
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Lead sponsor
Pfizer
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Start date
2024-01-09
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Number of sites
48
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Summary
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: * are 18 years of age or older; * are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; * have advanced or metastatic breast cancer after taking other treatments before this study; * have not taken or need to take medications that are not allowed by the study protocol; * do not have any medical or mental conditions that may increase the risk of study participation. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be: * Fulvestrant alone taken as shot into the muscle. * Everolimus along with exemestane taken once daily by mouth. This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: * imaging scans (such as an MRI and/or CT) show that their cancer is getting worse. * the study doctor thinks the participant is no longer benefitting from the study medicine. * has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. * the participant chooses to stop taking part.
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Short title
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
clinicaltrials.gov
Official title
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 2 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS AT LEAST 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY (FOURLIGHT-1)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-01-21
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First posted
2023-10-27
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Registry last updated
2026-08-20
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Primary completion date
2026-01-12
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Start date
2024-01-09
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Actual participants
333
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Participants
333
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Participant count basis
Actual
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Protocol amendments
6
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Number of sites
48
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06105632
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ClinicalTrials.gov ID
NCT06105632
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Progression-Free Survival (PFS) progression, as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Timeframe: From Initiation up to 2 years

  1. Overall Survival (OS)

    Timeframe: Time from the date of randomization to the date of death due to any cause up to approximately 3 years

  2. OR by investigator per RECIST v1.1

    Timeframe: 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 (up to approximately 2 years)

  3. Duration of Response (DOR) as defined by investigator per RECIST v1.1

    Timeframe: From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.

  4. Number of Participants With Clinical Benefit Response (CBR) by investigator per RECIST v1.1

    Timeframe: From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years

  5. Number or Patients with Adverse Events (AEs) by Type

    Timeframe: From screening until 28 days after the last dose, to approximately 3 years

  6. Number or Patients with AEs by Incidence

    Timeframe: From screening until 28 days after the last dose, to approximately 3 years

  7. Number or Patients with AEs by Seriousness

    Timeframe: From screening until 28 days after the last dose, to approximately 3 years

  8. Number or Patients with AEs by relationship to study interventions

    Timeframe: From screening until 28 days after the last dose, to approximately 3 years

  9. Number of Participants With Abnormal Electrocardiogram (ECG)

    Timeframe: From baseline to approximately 2 years

  10. Number of Participants With Laboratory Test Abnormalities

    Timeframe: From screening until 28 days after the last dose to approximately 2 years

  11. EQ-5D-5L

    Timeframe: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.

  12. EORTC QLQ

    Timeframe: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.

  13. EORTC QLQ Breast Cancer Module 23 (BR23)

    Timeframe: Screening Days 1, 15 of Cycle 1 and 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc) and EoT. Each Cycle is 28 days.

  14. Ctrough of PF-07220060

    Timeframe: Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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
  • Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
  • Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
  • Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.

  • Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
  • In visceral crisis at risk of immediately life-threatening complications in the short term.
  • Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
  • Prior treatment with any of the following:
  • Everolimus or investigational anti-cancer agents in any setting
  • Prior chemotherapy in the advanced setting
  • Radiation within 2 weeks of randomization
  • Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5' diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
  • Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.
Sources for eligibility
clinicaltrials.gov

  • Hoag Health Center IrvineIrvine, United States
  • Hoag Hospital IrvineIrvine, United States
  • Keck Hospital of USCLos Angeles, United States
  • Los Angeles General Medical CenterLos Angeles, United States
  • USC/Norris Comprehensive Cancer CenterLos Angeles, United States
  • Hoag Memorial Hospital PresbyterianNewport Beach, United States
  • MedStar Washington Hospital CenterWashington D.C., United States
  • Intermountain Health St. Vincent Regional HospitalBillings, United States
  • Memorial Hermann Cancer CenterHouston, United States
  • CIPRECBuenos Aires, Argentina
  • Clinica Viedma S. AViedma, Argentina
  • Instituto de Oncología de RosarioRosario, Argentina
  • Centro Para la Atención Integral del Paciente Oncologico (CAIPO)San Miguel de Tucumán, Argentina
  • Clínica Universitaria Reina FabiolaCórdoba, Argentina
  • Icon Cancer Centre TownsvilleRosslea, Australia
  • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial PernambucoRecife, Brazil
  • Liga Norte Riograndense Contra o CâncerNatal, Brazil
  • Hospital São Lucas da PUCRSPorto Alegre, Brazil
  • Royal Victoria Regional Health CentreBarrie, Canada
  • CIUSSS- saguenay-Lac-Saint-JeanChicoutimi, Canada
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and TechnologyWuhan, China
  • Hunan Cancer HospitalChangsha, China
  • Fudan University Shanghai Cancer CenterShanghai, China
  • Sahyadri Super Speciality HospitalPune, India
  • Rajiv Gandhi Cancer Institute And Research CentreNew Delhi, India

And 23 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-506487-13-00
Sources for references
clinicaltrials.gov

Related records

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Conditions (1)

Targets (3)