PF-07220060 MONOHYDRATE for Advanced breast cancer | Metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- •\tAt least 18 years of age (or the minimum age of consent in accordance with local regulations) at screening."}
• {"criterion_text":"- •\tPre/perimenopausal female and male participants must receive therapy with an LHRH agonist prior to the first dose of study intervention (if not already ongoing) and continue throughout the study as outlined in the SoA."}
• {"criterion_text":"- •\tHistological 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."}
• {"criterion_text":"- •\tDocumented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor"}
• {"criterion_text":"- •\tDocumented HER2-negative tumor"}
• {"criterion_text":"- •\tPreviously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease."}
• {"criterion_text":"- •\tParticipants must have either measurable disease or non-measurable bone-only disease per RECIST v1.1."}
• {"criterion_text":"- •\tParticipants must have an ECOG Performance Status of ≤2."}

Exclusion criteria

• {"criterion_text":"- •\tIn visceral crisis at risk of immediately life-threatening complications in the short term."}
• {"criterion_text":"- •\tCurrent or past history of central nervous system metastases."}
• {"criterion_text":"- •\tHave received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET."}
• {"criterion_text":"- •\tHave received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i."}
• {"criterion_text":"- •\tInadequate renal function, hepatic dysfunction, or hematologic abnormalities."}

Primary endpoints

• {"endpoint_text":"- •\tPFS by blinded independent central review (BICR)","definition_or_measurement_approach":"Progression-free survival assessed by Blinded Independent Central Review (BICR) as specified in protocol (BICR)."}

Secondary endpoints

• {"endpoint_text":"- •\tOS","definition_or_measurement_approach":"Not specified in source."}

Methods

• Recruitment arrangements and informed consent procedure documents provided (country-specific K1 recruitment arrangements documents).
• Patient-facing materials: study brochures and patient brochures for multiple countries (used as printed recruitment material).
• Digital recruitment: patient webpages / landing pages (country-specific), patient webpage content including FAQs and study pages (examples in Poland and other countries).
• Multimedia: patient videos with QR codes to link to study information (documents reference patient video QR codes, e.g., Greece, Poland).
• Onsite materials: study posters and printed recruitment posters (titles present in recruitment materials listings).
• Retention materials: unbranded retention items and appointment cards (documents include 'Unbranded Retention Items' and 'Appointment Card').

Bulgaria

Earliest CTIS Part Ii Submission Date

28-03-2025

Latest Decision Or Authorization Date

10-04-2025

Processing Time Days

13

Number Of Sites

8

Number Of Participants

90

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Altasciences Compagnie Inc.

Responsibilities

Biospecimen Testing

Name

Premier Research

Responsibilities

Dictionary Coding

Name

Ppd Inc.

Responsibilities

Central Laboratory Services

Name

Almac Clinical Services LLC

Responsibilities

Drug Destruction - Depot

Name

Clario

Responsibilities

Medical Imaging - Central Reader/Reading Service

Name

Clariness GmbH

Responsibilities

Recruitment and Retention

Name

Scout Clinical

Responsibilities

Patient Travel Support Services

Third parties

• {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"Biospecimen Testing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta Life Sciences","duties_or_roles":"Biospecimen Management","organisation_type":"Health care"}
• {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"Biospecimen Testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel Support Services","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Clario","duties_or_roles":"Medical Imaging - Central Reader/Reading Service","organisation_type":"Health care"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"Drug Destruction - Depot","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Biospecimen Testing","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Premier Research","duties_or_roles":"Dictionary Coding","organisation_type":"Industry"}
• {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Recruitment and Retention","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"Central Laboratory Services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"TecEx","duties_or_roles":"Import/export & License Services","organisation_type":"Industry"}