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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"><h1 id="summary--title"> Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation </h1><p class="h3 hide-long-content">a study on <span class="comma-list"><span class="comma-list-item"> <a href="../brca-1-gene-mutation">BRCA 1 Gene Mutation</a></span><span class="comma-list-item"> <a href="../breast-cancer">Breast Cancer</a></span><span class="comma-list-item"> <a href="../neoplasm">Neoplasms</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 females ages 25-55</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-check-circle fa-lg fa-fw" aria-hidden="true"></i> <span class="sr-only">Healthy Volunteers</span></dt><dd class="col-12 col-sm-11 col-lg-10"> <strong>healthy people welcome</strong> </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="2023-02-14">February 2023</time></span></div><div> completion around <time datetime="2033-12-31">December 2033</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2021-01-15"></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 N. 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 N. Munster" loading="lazy"><figcaption class="figure-caption">Pamela N. 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 phase III trial compares denosumab to placebo for the prevention of <a href="../breast-cancer" class="trial--link-to-condition-in-text">breast cancer</a> in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a <a href="../monoclonal-antibody" class="trial--link-to-condition-in-text">monoclonal antibody</a> that is used to treat <a href="../bone-loss" class="trial--link-to-condition-in-text">bone loss</a> in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation</p><h3 class="h4">Details</h3><div class="hide-long-content"><p>PRIMARY OBJECTIVE:</p><ol type="a"><li>To evaluate the reduction in the risk of any breast cancer (invasive or <a href="../ductal-carcinoma-in-situ" class="trial--link-to-condition-in-text">ductal carcinoma in situ</a> [DCIS]) in women with germline <a href="../brca-1-gene-mutation" class="trial--link-to-condition-in-text">BRCA1 mutation</a> who are treated with denosumab compared to placebo.</li></ol><p>SECONDARY OBJECTIVES:</p><ol type="a"><li>To determine the reduction in the risk of <a href="../breast-cancer" class="trial--link-to-condition-in-text">invasive breast cancer</a> in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.</li></ol><p>II. To determine the reduction in the risk of invasive <a href="../triple-negative-breast-cancer" class="trial--link-to-condition-in-text">triple negative breast cancer</a> (TNBC) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.</p><p>III. To determine the reduction in risk of ovarian, fallopian and <a href="../peritoneal-cancer" class="trial--link-to-condition-in-text">peritoneal cancers</a> (in women who have not undergone prophylactic bilateral salpingo-oophorectomy [PBSO]) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.</p><p>IV. To determine the reduction in risk of other (i.e. non-breast and nonovarian) malignancies, including those known to be associated with BRCA1 germline mutations in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.</p><ol type="a"><li>To determine the reduction in the risk of clinical fractures in pre- and postmenopausal women with germline BRCA1 mutation who are treated with denosumab compared to placebo.</li></ol><p>VI. To compare rates of breast biopsies and rate of benign breast lesions in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.</p><p>OUTLINE: Patients are randomized to 1 of 2 arms.</p><p>ARM A: Patients receive denosumab subcutaneously (SC) every 6 months (q6m) for up to 5 years in the absence of the development of breast cancer or unacceptable toxicity.</p><p>ARM B: Patients receive placebo SC q6m for up to 5 years in the absence of the development of breast cancer.</p><p>After completion of study treatment, patients are followed up every 12 months for 5 years.</p></div><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> <a href="../brca-1-gene-mutation" class="trial--link-to-condition-in-text">BRCA1 Mutation</a></span>, <span> Breast Cancer</span>, <span> Breast Diseases</span>, <span> Breast <a href="../neoplasm" class="trial--link-to-condition-in-text">Neoplasms</a></span>, <span> <a href="../breast-cancer" class="trial--link-to-condition-in-text">Breast Carcinoma</a></span>, <span> Neoplasms</span>, <span> RANKL</span>, <span> Breast Cancer Prevention</span>, <span> Denosumab</span>, <span> Bone Density Conservation Agents</span>, <span> Physiological Effects of Drugs</span>, <span> Quality-of-Life Assessment</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 females ages 25-55</strong></p><ul><li>Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (variant class 4 or 5)</li><li>Age >= 25 years and =< 55 years at randomization</li><li>No evidence of <a href="../breast-cancer" class="trial--link-to-condition-in-text">breast cancer</a> by MRI or mammography (MG) and clinical breast examination within the last 6 months prior to randomization</li><li>No clinical evidence of <a href="../ovarian-cancer" class="trial--link-to-condition-in-text">ovarian cancer</a> at randomization</li><li>Negative <a href="../pregnancy" class="trial--link-to-condition-in-text">pregnancy</a> test at randomization for women of childbearing potential</li><li>No preventive breast surgery planned at time of randomization</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1</li><li>Written informed consent before any study-specific procedure is performed</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><ul><li>Prior bilateral mastectomy</li><li>History of <a href="../ovarian-cancer" class="trial--link-to-condition-in-text">ovarian cancer</a> (including fallopian and <a href="../peritoneal-cancer" class="trial--link-to-condition-in-text">peritoneal cancer</a>)</li><li>History of <a href="../breast-cancer" class="trial--link-to-condition-in-text">breast cancer</a></li><li>History of invasive cancer except for basal cell or squamous cell skin cancer or <a href="../carcinoma-in-situ" class="trial--link-to-condition-in-text">carcinoma in situ</a> of the cervix, stage 1 papillary or follicular <a href="../thyroid-cancer" class="trial--link-to-condition-in-text">thyroid cancer</a>, atypical hyperplasia or LCIS (lobular carcinoma in situ)</li><li>Pregnant or lactating women (within the last 2 months prior to randomization)</li><li>Unwillingness to use highly effective <a href="../contraception" class="trial--link-to-condition-in-text">contraception</a> method during and within at least 5 months after cessation of denosumab/placebo therapy in women of childbearing potential. (Note: Women of childbearing potential should be monitored for pregnancy prior to each denosumab/placebo injection)</li><li>Clinically relevant hypocalcemia (history and current condition), or serum calcium < 2.0 mmol/L (< 8.0 mg/dL) <ul><li>Hypocalcemia defined by calcium below the normal range (a single value below the normal range does not necessarily constitute hypocalcemia, but should be 'corrected' before dosing the subject). Monitoring of calcium level in regular intervals (usually prior to investigational product [IP] administration) is highly recommended</li></ul></li><li>Tamoxifen, raloxifene or aromatase inhibitor use during the last 3 months prior to randomization or for a duration of more than 3 years in total (current and prior hormone replacement therapy [HRT] is permitted)</li><li>Prior use of denosumab</li><li>Subject has a known prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, or an active dental/jaw condition which requires oral surgery including tooth extraction within 3 months of enrollment</li><li>Concurrent treatment with a bisphosphonate or an anti-angiogenic agent</li><li>Any major medical or psychiatric condition that may prevent the subject from completing the study</li><li>Known active infection with <a href="../hepatitis-b" class="trial--link-to-condition-in-text">hepatitis B virus</a> or <a href="../hepatitis-c" class="trial--link-to-condition-in-text">hepatitis C virus</a></li><li>Known infection with human immunodeficiency virus (HIV)</li><li>Use of any other investigational product (current or prior aspirin or non-steroidal anti-inflammatory drugs [NSAIDs] are permitted)</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 location-is-institutional" itemprop="address" itemscope itemtype="https://schema.org/PostalAddress"><span class="location-name" itemprop="name">UCSF Medical Center-Mount Zion</span><wbr> <span class="badge badge-secondary">accepting new patients</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"> 94115</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">USC / Norris Comprehensive Cancer Center</span><wbr> <span class="badge badge-secondary">accepting new patients</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Los Angeles</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 90033</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 N. Munster</a> </strong> </span><br> Professor, Medicine, School of Medicine. Authored (or co-authored) 156 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"> accepting new patients </dd><dt class="col-sm-3 text-sm-right">Start Date</dt><dd class="col-sm-9"><time datetime="2023-02-14">February 2023</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2033-12-31">December 2033</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">Alliance for Clinical Trials in Oncology</dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/ct2/show/NCT04711109" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT04711109</a> </dd><dt class="col-sm-3 text-sm-right">Phase</dt><dd class="col-sm-9">Phase 3 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">Expecting 300 study participants</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="2024-10-24">October 24, 2024</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 class="text-center my-3"> <a href="#" id="contact-button-end" class="btn btn-primary btn-lg d-none d-md-inline" data-toggle="modal" data-target="#contact-modal" aria-description="Are you interested? 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Contact us to learn more about joining this clinical trial"> I’m interested in this study! </a> </div> <div class="modal fade" id="contact-modal" tabindex="-1" role="dialog" aria-labelledby="contact-modal-label" aria-hidden="true"><div class="modal-dialog modal-dialog-scrollable" role="document"><div class="modal-content"><div class="modal-header"><h4 class="modal-title h5" id="contact-modal-label">Please contact me about this study</h4> <button type="button" class="close" data-dismiss="modal" aria-label="Close"> <span aria-hidden="true">×</span> </button> </div><div class="modal-body"> <form id="contact-form" class="form-horizontal" action="https://clinicaltrials.ucsf.edu/action/trial-contact/" method="POST"> <input type="hidden" name="Trial_NCT" value="NCT04711109"> <input type="hidden" name="Trial_Title" value="Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation"> <input type="hidden" name="Trial_Contact" value="53616c7465645f5f0a141e28323c4650d31efb7a0901558848c267a95509412dcdb5758997024eb317af5a6d5d222810"> <div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-name">Name</label> <div class="col-sm-8 form-group--input-container"> <input name="Name" type="text" class="form-control form-control-lg" id="contact-name" placeholder="Your name" required pattern=".*\w\w.*" minlength="2" autocomplete="name"> </div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-email">Email</label> <div class="col-sm-8 form-group--input-container"> <input name="Email" type="email" class="form-control form-control-lg" id="contact-email" placeholder="Your email" required data-error="Invalid email address" autocomplete="email"> <div id="contact-email--suggestion" class="d-none small"> You typed <span id="contact-email--suggestion-original" class="text-monospace text-info font-weight-bold"></span>. 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Submitting your contact information does not obligate you to participate in research.</p></div> </div></div></div><div class="modal fade" id="contact-thank-you-modal" tabindex="-1" role="dialog" aria-hidden="true" aria-labelledby="contact-modal-label"><div class="modal-dialog" role="document"><div class="modal-content"><div class="modal-header"> <button type="button" class="close" data-dismiss="modal"><span aria-hidden="true">×</span><span class="sr-only">Close</span></button> <h4 class="modal-title h5" id="contact-thank-you-modal-label">Thank you!</h4></div><div class="modal-body"><p>The study team should get back to you in a few business days.</p><p>You will also receive an email with next steps. Check your junk/spam folder if needed.</p><p>If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT04711109.</p></div><div class="modal-footer"> <button type="button" class="btn btn-primary" data-dismiss="modal">OK</button> </div></div></div></div> <script type="application/ld+json"> [{"@context":"https://schema.org/","@type":"MedicalTrial","additionalType":"Product","alternateName":"BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation","code":{"@type":"MedicalCode","codeValue":"NCT04711109","codingSystem":"ClinicalTrials.gov"},"description":"This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. 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