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 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: C43910222023-506487-13-00
• Study Type: interventional
• Target: 333
• Locations: 14 countries
• Sites: 128

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.

Conditions

Advanced or Metastatic Breast Cancer

Keywords

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.

Outcome Measures

Primary Outcomes (1)

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

  From Initiation up to 2 years

Secondary Outcomes (14)

• Overall Survival (OS)

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

• OR by investigator per RECIST v1.1

  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)

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

  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.

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

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

• Number or Patients with Adverse Events (AEs) by Type

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

Study Arms (2)

Arm A

EXPERIMENTAL

PF-07220060 to be taken by mouth as a tablet in combination with fulvestrant (a solution for injection)

Drug: PF-07220060 CDK4 inhibitor; Drug: Fulvestrant

Arm B

ACTIVE COMPARATOR

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; Drug: Everolimus; Drug: Exemestane

Interventions

PF-07220060 CDK4 inhibitor DRUG

Experimental

Arm A

Fulvestrant DRUG

Experimental and Active comparator

Arm A; Arm B

Everolimus DRUG

Active Comparator

Arm B

Exemestane DRUG

Active Comparator

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (128)

Hoag Health Center Irvine

Irvine, California, 92618, United States

Location

Hoag Hospital Irvine

Irvine, California, 92618, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Keck Medical Center of USC Pasadena

Pasadena, California, 91105, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Intermountain Health St. Vincent Regional Hospital

Billings, Montana, 59101, United States

Location

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana

Billings, Montana, 59102, United States

Location

Cancer Care Specialists

Reno, Nevada, 89511, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

Memorial Hermann Cancer Center

Houston, Texas, 77030, United States

Location

Baylor Scott & White Medical Center - Round Rock

Round Rock, Texas, 78665, United States

Location

Centro de Investigaciones Medicas y Desarrollo LC

Buenos Aires, Buenos Aires F.D., 1113, Argentina

Location

CIPREC

Buenos Aires, Buenos Aires F.D., C1061, Argentina

Location

Organizacion Medica de Investigacion

CABA, Buenos Aires F.D., C1015ABO, Argentina

Location

Clinica Viedma S. A

Viedma, Río Negro Province, R8500ACE, Argentina

Location

Instituto de Oncología de Rosario

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

Centro Para la Atención Integral del Paciente Oncologico (CAIPO)

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI, Argentina

Location

Fundación Respirar

Ciudad Autónoma Buenos Aires, C1426ABP, Argentina

Location

Clínica Universitaria Reina Fabiola

Córdoba, X5004FHP, Argentina

Location

Fundación CORI para la Investigación y Prevención del Cáncer

La Rioja, F5300COE, Argentina

Location

COE (Centro Oncológico de Excelencia)

San Juan, 5400, Argentina

Location

Sanatorio Norte

Santiago del Estero, 4200, Argentina

Location

Macquarie University

North Ryde, New South Wales, 2109, Australia

Location

Icon Cancer Centre Townsville

Rosslea, Queensland, 4812, Australia

Location

Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Pernambuco

Recife, Pernambuco, 50070-480, Brazil

Location

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, 59062-000, Brazil

Location

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, 14784400, Brazil

Location

Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

São Caetano do Sul, São Paulo, 09541-270, Brazil

Location

Hospital Esperança Recife: Pronto Atendimento 24h

Pernambuco, 50070-480, Brazil

Location

Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick, E3B 5N5, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Beijing Cancer hospital

Beijing, Beijing Municipality, 100142, China

Location

The First People's Hospital of Foshan

Foshan, Guangdong, 528041, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, 530021, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jilin Province Tumor Hospital

Changchun, Jilin, 130000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Kiran Hospital - Multi Super Speciality Hospital and Research Center

Surat, Gujarat, 395004, India

Location

Spandana Oncology Centre (SOC)

Bangalore, Karnataka, 560069, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Kims Kingsway Hospital

Nagpur, Maharashtra, 440001, India

Location

Apex Wellness Hospital

Nashik, Maharashtra, 422009, India

Location

Sahyadri Super Speciality Hospital

Pune, Maharashtra, 411004, India

Location

Bhakti Vedanta Hospital and Research Institute

Thane, Maharashtra, 401107, India

Location

Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Rabin Medical Center

Petah Tikva, Central District, 4941492, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Jerusalem, 9103102, Israel

Location

Rambam Health Care Campus

Haifa, Northern District, 3109601, Israel

Location

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

Location

Gunma Prefectural Cancer Center

Otashi, Gunma, 373-8550, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1298, Japan

Location

St. Luke's International Hospital

Chuo-ku, Tokyo, 104-8560, Japan

Location

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

Location

Chiba cancer center

Chiba, 260-8717, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

Location

Boca Clinical Trials Mexico S.C.

Guadajalara, Jalisco, 44600, Mexico

Location

Cryptex Investigación Clínica S.A. de C.V.

Cuauhtémoc, Mexico City, 06100, Mexico

Location

Mexico Centre for Clinical Research S.A de C.V

Mexico City, Mexico City, 03100, Mexico

Location

COI Centro Oncologico Internacional S.A.P.I. de C.V.

Mexico City, Mexico City, 04700, Mexico

Location

Filios Alta Medicina S.A. de C.V.

Monterrey, Nuevo León, 64460, Mexico

Location

Unidad de Investigación en Salud de Chihuahua, S.C.

Chihuahua City, 31203, Mexico

Location

Oaxaca Site Management Organization S.C.

Oaxaca City, 68000, Mexico

Location

Instituto Veracruzano en Investigación Clínica S.C.

Veracruz, 91851, Mexico

Location

National Cancer Center

Goyang-si, Kyǒnggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea

Location

Ajou University Hospital

Suwon, Kyǒnggi-do, 16499, South Korea

Location

Pusan National University Hospital

Busan, Pusan-kwangyǒkshi, 49241, South Korea

Location

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03181, South Korea

Location

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 06273, South Korea

Location

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

Location

Korea University Guro Hospital

Seoul, Seoul-teukbyeolsi [seoul], 08308, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, Taegu-kwangyǒkshi, 42601, South Korea

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

Medipol Mega Universite Hastanesi

Stanbul, İ̇stanbul, 34214, Turkey (Türkiye)

Location

Acibadem Altunizade Hospital

Üsküdar / Stanbul, İ̇stanbul, Turkey (Türkiye)

Location

Gulhane Egitim Arastirma Hastanesi

Ankara, 06010, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

Ankara, 06200, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri

Ankara, 06230, Turkey (Türkiye)

Location

Ultramar Medical Imaging Center

Ankara, 06420, Turkey (Türkiye)

Location

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

Location

Ultramar Medical Imaging Center

Ankara, 06530, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

Dicle Üniversitesi

Diyarbakır, 21200, Turkey (Türkiye)

Location

Marmara Universitesi Pendik Egitim Arastirma Hastanesi

Istanbul, 34899, Turkey (Türkiye)

Location

Erciyes Universitesi Tıp Fakultesi Hastaneleri

Kayseri, Turkey (Türkiye)

Location

Necmettin Erbakan Meram Medical Fac.

Konya, 42080, Turkey (Türkiye)

Location

Samsun Medical Park Hastanesi

Samsun, 55200, Turkey (Türkiye)

Location

Sarah Cannon Research Institute UK

London, London, CITY of, w1g 6ad, United Kingdom

Location

The Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Imperial College Healthcare NHS Trust, Charing Cross Hospital

London, W68RF, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4GJ, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Interventions

Fulvestrant; Everolimus; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 27, 2023
• Study Start: January 9, 2024
• Primary Completion: January 12, 2026
• Study Completion (Estimated): January 21, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

JP (15); IN (8); ME (8); KR (11); GB (4); TW (7); US (17); IL (3); TU (14); AU (2); AR (12); BR (7); CN (16); CA (4)