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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced or Metastatic Breast Cancer
• Intervention / Treatment: Drug: Everolimus; Drug: Fulvestrant; Drug: Exemestane; Drug: PF-07220060 CDK4 inhibitor

• Study Type: Interventional
• Enrollment (Actual): 333
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1056ABI
    • Centro de Investigaciones Metabólicas (CINME)
  • Ciudad Autónoma Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar
  • Córdoba, Argentina, X5004FHP
    • Clínica Universitaria Reina Fabiola
  • La Rioja, Argentina, F5300COE
    • Fundación CORI para la Investigación y Prevención del Cáncer
  • San Juan, Argentina, 5400
    • COE (Centro Oncológico de Excelencia)
  • Santiago del Estero, Argentina, 4200
    • Sanatorio Norte
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1061
      • CIPREC
    • Buenos Aires, Buenos Aires F.D., Argentina, 1113
      • Centro de Investigaciones Medicas y Desarrollo LC
    • CABA, Buenos Aires F.D., Argentina, C1015ABO
      • Organizacion Medica de Investigacion
  • Río Negro Province
    • Viedma, Río Negro Province, Argentina, R8500ACE
      • Clinica Viedma S. A
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000KZE
      • Instituto de Oncología de Rosario
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
• Australia
  • New South Wales
    • North Ryde, New South Wales, Australia, 2109
      • Macquarie University
  • Queensland
    • Rosslea, Queensland, Australia, 4812
      • Icon Cancer Centre Townsville
• Brazil
  • Pernambuco, Brazil, 50070-480
    • Hospital Esperança Recife: Pronto Atendimento 24h
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-480
      • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Pernambuco
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59062-000
      • Liga Norte Riograndense Contra o Câncer
  • Rio Grande do Sul
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital São Lucas da PUCRS
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784400
      • Fundação Pio XII - Hospital de Câncer de Barretos
    • São Caetano do Sul, São Paulo, Brazil, 09541-270
      • Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5N5
      • Dr. Everett Chalmers Regional Hospital
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • CIUSSS- saguenay-Lac-Saint-Jean
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100021
      • Cancer Hospital Chinese Academy of Medical Science
  • Guangdong
    • Foshan, Guangdong, China, 528041
      • The First People's Hospital of Foshan
    • Guangzhou, Guangdong, China, 510000
      • Guangdong Provincial People's Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Affiliated Tumor Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130000
      • Jilin Province Tumor Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • The First Hospital of China Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
• India
  • Gujarat
    • Surat, Gujarat, India, 395004
      • Kiran Hospital - Multi Super Speciality Hospital and Research Center
  • Karnataka
    • Bangalore, Karnataka, India, 560069
      • Spandana Oncology Centre (SOC)
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Tata Memorial hospital
    • Nagpur, Maharashtra, India, 440001
      • Kims Kingsway Hospital
    • Nashik, Maharashtra, India, 422009
      • Apex Wellness Hospital
    • Pune, Maharashtra, India, 411004
      • Sahyadri Super Speciality Hospital
    • Thane, Maharashtra, India, 401107
      • Bhakti Vedanta Hospital and Research Institute
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110085
      • Rajiv Gandhi Cancer Institute And Research Centre
• Israel
  • Central District
    • Petah Tikva, Central District, Israel, 4941492
      • Rabin Medical Center
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 9103102
      • Shaare Zedek Medical Center
  • Northern District
    • Haifa, Northern District, Israel, 3109601
      • Rambam Health Care Campus
• Japan
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Hiroshima, Japan, 730-8518
    • Hiroshima City Hiroshima Citizens Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Japan, 540-0006
    • National Hospital Organization Osaka National Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Nagoya University Hospital
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Gunma
    • Otashi, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Osaka
    • Osaka, Osaka, Japan, 541-8567
      • Osaka International Cancer Institute
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-8560
      • St. Luke's International Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital of JFCR
• Mexico
  • Chihuahua City, Mexico, 31203
    • Unidad de Investigación en Salud de Chihuahua, S.C.
  • Oaxaca City, Mexico, 68000
    • Oaxaca Site Management Organization S.C.
  • Veracruz, Mexico, 91851
    • Instituto Veracruzano en Investigación Clínica S.C.
  • Jalisco
    • Guadajalara, Jalisco, Mexico, 44600
      • Boca Clinical Trials Mexico S.C.
  • Mexico City
    • Cuauhtémoc, Mexico City, Mexico, 06100
      • Cryptex Investigación Clínica S.A. de C.V.
    • Mexico City, Mexico City, Mexico, 03100
      • Mexico Centre for Clinical Research S.A de C.V
    • Mexico City, Mexico City, Mexico, 04700
      • COI Centro Oncologico Internacional S.A.P.I. de C.V.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Filios Alta Medicina S.A. de C.V.
• South Korea
  • Kyǒnggi-do
    • Goyang-si, Kyǒnggi-do, South Korea, 10408
      • National Cancer Center
    • Seongnam, Kyǒnggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Kyǒnggi-do, South Korea, 16499
      • Ajou University Hospital
  • Pusan-kwangyǒkshi
    • Busan, Pusan-kwangyǒkshi, South Korea, 49241
      • Pusan National University Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03181
      • Kangbuk Samsung Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 05505
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06273
      • Gangnam Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 08308
      • Korea University Guro Hospital
  • Taegu-kwangyǒkshi
    • Daegu, Taegu-kwangyǒkshi, South Korea, 42601
      • Keimyung University Dongsan Hospital
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Egitim Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe Universite Hastaneleri
  • Ankara, Turkey (Türkiye), 06420
    • Ultramar Medical Imaging Center
  • Ankara, Turkey (Türkiye), 06530
    • Ultramar Medical Imaging Center
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Sehir Hastanesi
  • Diyarbakır, Turkey (Türkiye), 21200
    • Dicle Üniversitesi
  • Istanbul, Turkey (Türkiye), 34899
    • Marmara Universitesi Pendik Egitim Arastirma Hastanesi
  • Kayseri, Turkey (Türkiye)
    • Erciyes Universitesi Tıp Fakultesi Hastaneleri
  • Konya, Turkey (Türkiye), 42080
    • Necmettin Erbakan Meram Medical Fac.
  • Samsun, Turkey (Türkiye), 55200
    • Samsun Medical Park Hastanesi
  • İ̇stanbul
    • Stanbul, İ̇stanbul, Turkey (Türkiye), 34214
      • Medipol Mega Universite Hastanesi
    • Üsküdar / Stanbul, İ̇stanbul, Turkey (Türkiye)
      • Acibadem Altunizade Hospital
• United Kingdom
  • Guildford, United Kingdom, GU2 7XX
    • The Royal Surrey County Hospital
  • London, United Kingdom, W68RF
    • Imperial College Healthcare NHS Trust, Charing Cross Hospital
  • Manchester, United Kingdom, M20 4GJ
    • The Christie NHS Foundation Trust
  • London, CITY of
    • London, London, CITY of, United Kingdom, w1g 6ad
      • Sarah Cannon Research Institute UK
• United States
  • California
    • Irvine, California, United States, 92618
      • Hoag Hospital Irvine
    • Irvine, California, United States, 92618
      • Hoag Health Center Irvine
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • Los Angeles, California, United States, 90033
      • Los Angeles General Medical Center
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
    • Pasadena, California, United States, 91105
      • Keck Medical Center of USC Pasadena
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Hospital
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Montana
    • Billings, Montana, United States, 59101
      • Intermountain Health St. Vincent Regional Hospital
    • Billings, Montana, United States, 59102
      • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
  • Nevada
    • Reno, Nevada, United States, 89511
      • Cancer Care Specialists
  • New York
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Cancer Center
    • Round Rock, Texas, United States, 78665
      • Baylor Scott & White Medical Center - Round Rock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Fulvestrant; Experimental and Active comparator; Drug: PF-07220060 CDK4 inhibitor; Experimental
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: Everolimus; Active Comparator; Drug: Fulvestrant; Experimental and Active comparator; Drug: Exemestane; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Time from the date of randomization to the date of death due to any cause up to approximately 3 years
Number or Patients with Adverse Events (AEs) by Type	From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Incidence	From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by Seriousness	From screening until 28 days after the last dose, to approximately 3 years
Number or Patients with AEs by relationship to study interventions	From screening until 28 days after the last dose, to approximately 3 years
Number of Participants With Abnormal Electrocardiogram (ECG)	From baseline to approximately 2 years
Number of Participants With Laboratory Test Abnormalities	From screening until 28 days after the last dose to approximately 2 years
Ctrough of PF-07220060	Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycle 3 (Day 1). Each Cycle is 28 days
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
EQ-5D-5L	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.
EORTC QLQ	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.
EORTC QLQ Breast Cancer Module 23 (BR23)	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.

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Actual): January 12, 2026
• Study Completion (Estimated): January 21, 2028

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Breast Cancer; Breast cancer; Metastatic breast cancer; everolimus; HR+; Recurrent; Relapse; Hormone Therapy; Recurrent breast cancer; HER2-negative; fulvestrant; exemestane; Breast tumor; Hormone positive breast cancer; Estrogen receptor positive [ER(+)]; Human epidermal growth factor receptor 2 negative [HER(-)]; ER(+)/HER2(-); Partial Response+ (PR+); Second line treatment.
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Recurrence; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Organic Chemicals; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Macrolides; Lactones; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Sirolimus; Fulvestrant; Everolimus; exemestane
• Other Study ID Numbers: C4391022; 2023-506487-13-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No