Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06105632

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Advanced or Metastatic Breast Cancer Breast Diseases Breast Neoplasms Disease Attributes Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CIPREC, Buenos Aires, Buenos Aires F.D., Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PF-07220060 CDK4 inhibitor

Drug

Experimental

Fulvestrant

Drug

Experimental and Active comparator

Everolimus

Drug

Active Comparator

Exemestane

Drug

Active Comparator

Primary outcomes

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

    Time frame: From Initiation up to 2 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

  6. Number or Patients with AEs by Incidence

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

  7. Number or Patients with AEs by Seriousness

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

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

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

  9. Number of Participants With Abnormal Electrocardiogram (ECG)

    Time frame: From baseline to approximately 2 years

  10. Number of Participants With Laboratory Test Abnormalities

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

  11. EQ-5D-5L

    Time frame: 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

    Time frame: 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)

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Oct 27, 2023
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.