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method="GET" action="https://clinicaltrials.ucsf.edu/" class="form-inline my-1" role="search"> <label class="sr-only" for="header-search--input">Search</label> <input id="header-search--input" name="q" type="text" class="form-control form-control-sm" placeholder="Search UCSF clinical trials" title="Search clinical trials at UCSF"> <input class="sr-only form-control-sm btn btn-sm btn-secondary" type="submit" value="Search trials"> </form></div></div> </nav></header><main id="content" class="mx-1 mx-md-0"> <div class="container-xl px-5"><div class="row"><div class="col-md-9 col-lg-8" role="main" id="main-column"><div id="summary" class="page-header show-jargon-definitions"><div class="h3 alert alert-danger text-center">This study is in progress, not accepting new patients</div><h1 id="summary--title"> A Phase 1/2 Trial of ARV-471 Alone and in Combination with Palbociclib (IBRANCE®) in Patients with ER+/HER2- Locally Advanced or Metastatic Breast Cancer </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../breast-cancer">Breast Cancer</a></span><span class="comma-list-item"> <a href="../her2">HER2</a></span></span></p></div><div id="trial-details-container"><div id="key-points" class="trial-details-block"><div class="row"> <div class="col"><h2 class="sr-only h3">Summary</h2><dl id="key-points-bullets" class="row"><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Eligibility</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>for people ages 18 years and up</strong> (<a href="#eligibility">full criteria</a>) </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-map-marker fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Location</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <a href="#location"> at San Francisco, California and other locations </a> </dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-calendar fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Dates</span></dt><dd class="col-12 col-sm-11 col-lg-10"><div> study started <span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateCreated" datetime="2019-08-05">August 2019</time></span></div><div> completion around <time datetime="2025-03-13">March 13, 2025</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2019-08-28"></div></dd><dt class="d-none d-sm-block col-sm-1 col-lg-2"> <i class="fa fa-user-md fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Principal Investigator</span></dt><dd class="col-12 col-sm-11 col-lg-10 comma-list"> by <span class="pi-name comma-list-item"><span><a href="https://profiles.ucsf.edu/pamela.munster" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Pamela Munster</a></span></span></dd></dl></div> <div class="d-none d-md-block col-md-auto" id="pi-photos-block"><figure class="figure"><img class="pi-photo figure-img img-fluid rounded" src="https://researcherprofiles.org/profile/Modules/CustomViewPersonGeneralInfo/PhotoHandler.ashx?NodeID=196313" alt="Headshot of Pamela Munster" loading="lazy"><figcaption class="figure-caption">Pamela Munster</figcaption></figure></div></div></div><div id="description" class="trial-details-block"><h2 class="h3">Description</h2><div class="show-jargon-definitions"><h3 class="h4">Summary</h3><div class="hide-long-content"><p>This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCE®) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) <a href="../breast-cancer" class="trial--link-to-condition-in-text">locally advanced or metastatic breast cancer</a>, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">A Phase 1/2, Open Label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-471 Alone and in Combination with Palbociclib (IBRANCE®) in Patients with Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer, Who Have Received Prior Hormonal Therapy and Chemotherapy in the Locally Advanced/Metastatic Setting</p><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> Breast Cancer</span>, <span> Metastatic Breast Cancer</span>, <span> Malignant Neoplasm of the Breast</span>, <span> mBC</span>, <span> ER+/HER2-</span>, <span> <a href="../breast-cancer" class="trial--link-to-condition-in-text">Locally Advanced Breast Cancer</a></span>, <span> ARV-471</span>, <span> Vepdegestrant</span>, <span> Palbociclib</span>, <span> Ibrance</span>, <span> Breast <a href="../neoplasm" class="trial--link-to-condition-in-text">Neoplasms</a></span>, <span> ARV-471 in combination with palbociclib (IBRANCE®)</span>, <span> ARV-471 and palbociclib (IBRANCE®)</span></p></div></div><div id="eligibility" class="trial-details-block show-jargon-definitions"><h2 class="h3">Eligibility</h2><div class="hide-long-content"><div class="row"><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-check-square-o" aria-hidden="true"></i> You can join if… </h3><div><p><strong>Open to people ages 18 years and up</strong></p><p>Part A, Part B, and Part C:</p><ul><li> Patients at least 18 years of age at the time of signing the informed consent.</li><li> Patients must have histologically or cytologically confirmed ER+ and HER2- <a href="../breast-cancer" class="trial--link-to-condition-in-text">advanced breast cancer</a> for which standard curative therapy is no longer effective or does not exist.</li><li> Patients must have measurable or non-measurable disease by RECIST criteria (version1.1), with radiologic tumor assessments performed within 28 days of the first dose of therapy.</li><li> Patients must be willing to undergo a core biopsy of accessible tumor within 4 weeks prior to the initiation of study treatment and a follow-up biopsy on treatment for ER IHC testing and PD studies. (Patients without accessible tumor tissue may be eligible after discussion with the Medical Monitor.)</li><li> Women must be postmenopausal due to surgical or natural <a href="../menopause" class="trial--link-to-condition-in-text">menopause</a>.</li></ul><p>Part A:</p><ul><li> Patients must have received at least 2 prior endocrine regimens in any setting (neoadjuvant, adjuvant or advanced/metastatic) a CDK4/6 inhibitor and up to 3 prior regimens of cytotoxic chemotherapy in the locally advanced or metastatic setting.</li></ul><p>Part B:</p><ul><li> Patients must have received at least 1 prior endocrine regimen for a minimum of 6 months in the locally advanced or metastatic setting; if more than 1 prior endocrine regimen has been administered, only one of the regimens must have been administered for a minimum of 6 months in the locally advanced or metastatic setting</li><li> Patients must have received a CDK4/6 inhibitor</li><li> Patients must have received up to 1 prior regimen of cytotoxic chemotherapy in the locally advanced or metastatic setting</li><li> Women must be postmenopausal due to surgical or natural menopause.</li></ul><p>Part C:</p><ul><li> Patients must have received at least one prior endocrine regimen.</li><li> Patients must have received no more than two prior chemotherapy regimens for advanced disease.</li><li> Women must be postmenopausal due to surgical or natural menopause.</li></ul></div></div><div class="col-12 col-lg-6"><h3 class="h4 mt-0"> <i class="fa fa-ban" aria-hidden="true"></i> You CAN'T join if... </h3><div><p>Part A, Part B, and Part C:</p><ul><li> Patients with known symptomatic <a href="../brain-cancer" class="trial--link-to-condition-in-text">brain metastases</a> requiring steroids (above physiologic replacement doses). Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to first dose of study drug, have discontinued high-dose corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable as judged by the Investigator.</li><li> Receipt of prior anti-cancer or other investigational therapy within 14 days prior to the first administration of study drug.</li><li> Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to <a href="../bone-cancer" class="trial--link-to-condition-in-text">bone metastasis</a> will be allowed during the study.</li></ul></div></div></div></div></div><div id="location" class="trial-details-block"><h2 class="h3">Locations</h2><ul id="locations-list" class="hide-long-content "><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Clinical Trial Site</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> San Francisco</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94158</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li><li class="location " itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">Clinical Trial Site</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Palo Alto</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 94304</span><span class="comma-list-item" itemprop="addressCountry"> United States</span></span></li></ul></div><div id="pis" class="trial-details-block"><h2 class="h3">Lead Scientist <span class="d-none d-sm-inline">at UCSF</span></h2><ul class="pis-list--only-one-pi"><li class="pi"><span class="pi-name"> <strong> <a href="https://profiles.ucsf.edu/pamela.munster" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Pamela Munster</a> </strong> </span><br> Professor, Medicine, School of Medicine. Authored (or co-authored) 161 research publications </li></ul></div><div id="details" class="trial-details-block"><h2 class="h3">Details</h2><dl class="row"><dt class="col-sm-3 text-sm-right">Status</dt><dd class="col-sm-9"> in progress, not accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2019-08-05">August 2019</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2025-03-13">March 13, 2025</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Arvinas Estrogen Receptor, Inc.</dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/study/NCT04072952" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT04072952</a> </dd><dt class="col-sm-3 text-sm-right">Phase</dt><dd class="col-sm-9">Phase 1/2 research study</dd><dt class="col-sm-3 text-sm-right">Study Type</dt><dd class="col-sm-9">Interventional</dd><dt class="col-sm-3 text-sm-right">Participants</dt><dd class="col-sm-9">About 217 people participating</dd><dt class="col-sm-3 text-sm-right">Last Updated</dt><dd class="col-sm-9"><span itemscope itemtype="https://schema.org/WebPage"><time itemprop="dateModified" datetime="2025-02-10">February 10, 2025</time></span></dd></dl></div><div id="faq" class="trial-details-block d-print-none" role="complementary"><h2 class="h3">Frequently Asked Questions</h2><ul><li><a href="../about/how-clinical-trials-work">How Do Clinical Trials Work?</a></li><li><a href="../about/what-to-expect">What to Expect</a></li><li><a href="../about/who-can-join">Who Can Join</a></li><li><a href="../about/our-researchers">Our Researchers</a></li></ul></div></div> </div><div class="col-md-3 text-center offset-lg-1 d-none d-md-block d-print-none" id="secondary-column"> <div id="sidebar"></div> </div></div> </div> <script type="application/ld+json"> [{"@context":"https://schema.org/","@type":"MedicalTrial","additionalType":"Product","alternateName":"A Phase 1/2, Open Label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-471 Alone and in Combination with Palbociclib (IBRANCEÂ®) in Patients with Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer, Who Have Received Prior Hormonal Therapy and Chemotherapy in the Locally Advanced/Metastatic Setting","code":{"@type":"MedicalCode","codeValue":"NCT04072952","codingSystem":"ClinicalTrials.gov"},"description":"This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCEÂ®) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.","healthCondition":[{"@type":"MedicalCondition","name":"Breast Cancer"},{"@type":"MedicalCondition","name":"HER2"}],"name":"A Phase 1/2 Trial of ARV-471 Alone and in Combination with Palbociclib (IBRANCEÂ®) in Patients with ER+/HER2- Locally Advanced or Metastatic Breast Cancer","sameAs":"https://clinicaltrials.gov/study/NCT04072952","sponsor":[{"@type":"Organization","name":"Arvinas Estrogen Receptor, Inc."},{"@context":"https://schema.org/","@type":"Person","affiliation":{"@type":"Organization","name":"UCSF"},"description":"Professor, Medicine, School of Medicine. 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