Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer
NCT ID: NCT05909397
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
59 participants
INTERVENTIONAL
2023-08-09
2026-12-30
Brief Summary
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This study is seeking participants who have breast cancer that:
* Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body.
* Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease.
* Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane.
The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with vepdegestrant will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with vepdegestrant.
In the Phase 3, half of the participants will take vepdegestrant plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks.
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Detailed Description
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The study will have a Study Lead-in (SLI) and a Phase 3. In the SLI, 50 participants (approximately 25 each arm) will be randomly assigned on a 1:1 basis to one of the two dose levels (DLs). In the randomized Phase 3, approximately 1130 eligible participants (approximately 565 each arm) will be randomized in a 1:1 ratio to the Experimental Arm (ie, vepdegestrant plus palbociclib at RP3D determined in the SLI) or Control Arm (ie, letrozole plus palbociclib at the registered doses). Randomization will be stratified by menopausal status at study entry, visceral disease and de novo metastatic disease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Investigational Arm)
Participants will receive:
* Vepdegestrant, orally, once daily, continuously, in a 28-day cycle, plus
* Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment in a 28 day cycle
Vepdegestrant (ARV-471/PF-07850327)
Pharmaceutical form: Tablets. Route of Administration: Oral
Palbociclib
Pharmaceutical form: Capsules. Route of Administration: Oral.
Arm B (Comparator Arm):
Participants will receive:
* Letrozole, orally, once daily, continuously, in a 28-day cycle, plus
* Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment, in a 28-day cycle.
Letrozole
Pharmaceutical form: Capsules. Route of Administration: Orally
Palbociclib
Pharmaceutical form: Capsules. Route of Administration: Oral.
Interventions
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Vepdegestrant (ARV-471/PF-07850327)
Pharmaceutical form: Tablets. Route of Administration: Oral
Palbociclib
Pharmaceutical form: Capsules. Route of Administration: Oral.
Letrozole
Pharmaceutical form: Capsules. Route of Administration: Orally
Palbociclib
Pharmaceutical form: Capsules. Route of Administration: Oral.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of ER+/HER2- breast cancer
* No prior systemic treatment for loco-regional recurrent or metastatic disease
* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Phase 3 only: Participants should be willing to provide blood and tumor tissue
Exclusion Criteria
* Prior treatment with cyclin dependent kinase 4/6 inhibitors (CDK4/6i), vepdegestrant, fulvestrant, elacestrant and other investigational drugs including novel endocrine therapies, any selective estrogen receptor degraders (SERDs), covalent antagonists (SERCAs) and complete ER antagonists (CERANs).
* Inadequate liver, kidney and bone marrow function
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Refractory nausea and vomiting, inability to swallow capsules and tablets whole, chronic gastrointestinal diseases, significant gastric (total or partial) or bowel resection that would preclude adequate absorption of study interventions.
* Current use or anticipated need for food, herbal supplements or drugs that are known strong CYP3A4 inhibitors or inducers.
18 Years
ALL
No
Sponsors
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Arvinas Estrogen Receptor, Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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BRCR Global
Plantation, Florida, United States
BRCR Medical Center Inc
Plantation, Florida, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Cancer Research SA
Adelaide, South Australia, Australia
Barwon Health
Geelong, Victoria, Australia
Hospital Santa Rita de Cassia
Vitória, Espírito Santo, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Clínica - Área Administrativa
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, Campania, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Nemocnica na okraji mesta n o
Partizánske, , Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana Presov
Prešov, , Slovakia
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [barcelona], Spain
Hospital Universitari Dexeus
Barcelona, Catalunya [cataluña], Spain
Complejo Hospitalario de Jaén
Jaén, JAÉN, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Unviersitario Virgen Nieves
Granada, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Tumor Zentrum Aarau
Aarau, Canton of Aargau, Switzerland
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-500545-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4891002
Identifier Type: -
Identifier Source: org_study_id
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