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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

completed 13 Feb 2025

Decision date (initial)

2024-07-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-506487-13-00

ClinicalTrials.gov

NCT06105632

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Pharmacodynamic

To compare the efficacy of PF-07220060 plus fulvestrant(Arm A) versus ICT (Arm B) with respect to progression free survival (PFS)

Secondary objectives 5

1. To compare Arm A versus Arm B with respect to overall survival (OS)
2. To compare Arm A versus Arm B with respect to measures of tumor control and to evaluate duration of response within each treatment arm
3. To compare safety and tolerability between Arm A and Arm B
4. To evaluate patient-reported outcomes of health-related quality of life, diseasetreatment- related symptoms, and general health status for each treatment arm
5. To determine trough plasma concentrations of PF- 07220060 when given in combination with fulvestrant and explore the relationship between exposure and efficacy/safety in this participant population

Conditions and MedDRA coding

Hormone receptor-positive, her2-negative advanced/metastatic breast cancer

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD 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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. At least 18 years of age (or the minimum age of consent in accordance with local regulations) at screening.
2. 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.
3. Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
4. Must have received prior CDK4/6i plus non-steroidal aromatase inhibitor (NSAI) in 1 of the following 3 scenarios. There must be documented PD/ recurrence during or within 12 months after the last dose of CDK4/6i. 1: One prior line of systemic therapy for A/mBC, which must be CDK4/6i plus NSAI; 2: Two prior lines of systemic therapy for A/mBC, one must be CDK4/6i plus NSAI and the other an approved treatment targeting estrogen receptor 1 (ESR1), phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), AKT1, phosphatase and tensin homolog (PTEN) or breast cancer gene (BRCA); 3: No prior systemic therapies for A/mBC, but received CDK4/6i plus NSAI as the most recent adjuvant therapy.
5. Measurable disease or non-measurable bone only disease as defined by RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.

Exclusion criteria 6

1. Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
2. In visceral crisis at risk of immediately life-threatening complications in the short term.
3. Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
4. 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
5. 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).
6. Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PFS, defined as the time from the date of randomization to the date of first documented disease progression, as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause in the absence of progression of disease (PD), whichever occurs first

Secondary endpoints 5

1. OS, defined as the time from the date of randomization to the date of death due to any cause
2.  PFS by investigator  Objective Response (OR) by BICR and by investigator per RECIST v1.1  Duration of Response (DoR) by BICR and by investigator per RECIST v1.1  Clinical Benefit Response (CBR: complete response [CR], partial response [PR], or stable disease [SD]/Non-CR/Non-progression of disease [non-PD] ≥24 weeks) by BICR and by investigator per RECIST v1.1.
3. Type, incidence, severity (as graded by the National Cancer Institute Common Terminology for Adverse Events [NCI CTCAE v5.0]), seriousness and relationship to study interventions of adverse events (AEs), and any laboratory test and electrocardiogram (ECG) abnormalities
4. Patient reported outcomes (PROs) endpoints of global quality of life, symptoms, and functioning assessed using the European Quality of Life 5 Domain 5 Level Scale (EQ-5D-5L), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and EORTC QLQ Breast Cancer Module 23 (BR23)
5. C_trough of PF-07220060

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 7

Locations

14 EU/EEA countries · 119 investigational sites

By country

Investigational sites

Application history

2 submissions — initial application plus substantial / non-substantial modifications