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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

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ClinicalTrials.gov Identifier: NCT06105632
Recruitment Status : Recruiting
First Posted : October 27, 2023
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Breast Cancer Drug: PF-07220060 CDK4 inhibitor Drug: Fulvestrant Drug: Everolimus Drug: Exemestane Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS OVER 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
Actual Study Start Date : January 9, 2024
Estimated Primary Completion Date : December 16, 2025
Estimated Study Completion Date : December 14, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection)
 Drug: PF-07220060 CDK4 inhibitor
Experimental

Drug: Fulvestrant
Experimental and Active comparator
Active Comparator: Arm B

Investigator's choice of therapy of either:

  • Fulvestrant alone (a solution for injection), or
  • Everolimus in combination with exemestane, both a tablet to be taken by mouth.
 Drug: Fulvestrant
Experimental and Active comparator

Drug: Everolimus
Active Comparator

Drug: Exemestane
Active Comparator


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) progression, as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: From Initiation up to 2 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Time from the date of randomization to the date of death due to any cause up to approximately 5 years ]
  2. PFS as defined by investigator [ Time Frame: Time from the date of randomization up to approximately 2 years ]
  3. OR by BICR and 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) ]
  4. Duration of Response (DOR) as define by Blinded Independent Central Review (BICR) and 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. ]
  5. Number of Participants With Clinical Benefit Response (CBR) by BICR and 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 ]
  6. Number or Patients with Adverse Events (AEs) by Type [ Time Frame: From screening until 28 days after the last dose, to approximately 3 years ]
  7. Number or Patients with AEs by Incidence [ Time Frame: From screening until 28 days after the last dose, to approximately 3 years ]
  8. Number or Patients with AEs by Seriousness [ Time Frame: From screening until 28 days after the last dose, to approximately 3 years ]
  9. 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 ]
  10. Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: From baseline to approximately 2 years ]
  11. Number of Participants With Laboratory Test Abnormalities [ Time Frame: From screening until 28 days after the last dose to approximately 2 years ]
  12. 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), EoT and Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days ]
  13. 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), EoT and Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days ]
  14. 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), EoT and Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days ]
  15. Ctrough of PF-07220060 [ Time Frame: Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06105632


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT06105632    
Other Study ID Numbers: C4391022
2023-506487-13-00 ( Registry Identifier: CTIS (EU) )
First Posted: October 27, 2023    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Estrogen receptor positive [ER(+)]
Human epidermal growth factor receptor 2 negative [HER(-)]
ER(+)/HER2(-)
Advanced Breast Cancer
Breast tumor
Breast cancer
fulvestrant
everolimus
exemestane
Partial Response+ (PR+)
 Metastatic breast cancer
Hormone Therapy
Hormone positive breast cancer
Recurrent breast cancer
HR+
HER2-negative
Relapse
Recurrent
Second line treatment.
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Everolimus
Fulvestrant
Exemestane
MTOR Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Aromatase Inhibitors
Steroid Synthesis Inhibitors