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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"> Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) </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 18-99</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="2021-05-10">May 2021</time></span></div><div> completion around <time datetime="2029-08-14">August 2029</time></div><div itemscope itemtype="https://schema.org/WebPage" aria-hidden="true" class="d-none"><meta itemprop="datePublished" content="2021-04-28"></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/hope.rugo" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Hope Rugo</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=182790" alt="Headshot of Hope Rugo" loading="lazy"><figcaption class="figure-caption">Hope Rugo</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>A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or <a href="../breast-cancer" class="trial--link-to-condition-in-text">Metastatic Breast Cancer</a> (CAPItello-292)</p></div><h3 class="h4">Official Title</h3><p class="hide-long-content">A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)</p><h3 class="h4">Details</h3><div class="hide-long-content"><p>This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- <a href="../breast-cancer" class="trial--link-to-condition-in-text">breast cancer</a>. Although the dosing regimens of capivasertib + fulvestrant and of CDK4/6i + fulvestrant are established separately, the dose and schedule for the triplet combinations (capivasertib + CDK4/6i + fulvestrant) need to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will determine the recommended Phase III doses (RP3D) of the triplet combinations. The Phase III part of the study will evaluate the efficacy, safety and the degree of added benefit of the triplet combinations of capivasertib and fulvestrant with investigator's choice of CDK4/6i (either palbociclib or ribociclib at safe and tolerable doses, once identified) in comparison with a control arm (fulvestrant + investigator's choice of CDK4/6i [palbociclib or ribociclib]) in a ER+ HER2- maC high risk population that did not receive prior endocrine therapy in the advanced setting.</p></div><h3 class="h4">Keywords</h3><p class=" hide-long-content"><span> Locally Advanced (Inoperable) or <a href="../breast-cancer" class="trial--link-to-condition-in-text">Metastatic Breast Cancer</a></span>, <span> Breast <a href="../neoplasm" class="trial--link-to-condition-in-text">Neoplasms</a></span>, <span> Fulvestrant</span>, <span> Palbociclib</span>, <span> Capivasertib</span>, <span> Ribociclib</span>, <span> Abemaciclib</span>, <span> Capivasertib Plus Palbociclib and Fulvestrant</span>, <span> Capivasertib Plus Ribociclib and Fulvestrant</span>, <span> Capivasertib Plus Abemaciclib and Fulvestrant</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 18-99</strong></p><p>for both phases:</p><ol><li>Adult females (pre-/peri-/ and post-menopausal), and adult males.</li><li>Histologically confirmed HR+/ HER2- <a href="../breast-cancer" class="trial--link-to-condition-in-text">breast cancer</a> determined from the most recent tumour sample (primary or metastatic) per the American Society of Clinical Oncology and College of American Pathologists guideline. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.</li><li>Eligible for fulvestrant therapy and at least one of the following: palbociclib, ribociclib, or abemaciclib, as per local investigator assessment. Previous tolerance to specific CDK4/6 inhibitors and dose levels required.</li><li>Adequate organ and bone marrow functions.</li><li>Consent to provide a mandatory FFPE tumour sample.</li></ol><p>Key inclusion criteria only for phase III:</p><ol><li>Previous treatment with an ET (tamoxifen, AI, or oral SERD) as a single agent or in combination, with radiological evidence of breast cancer recurrence or progression while on, or within 12 months of, completing a (neo)adjuvant ET regimen.</li><li>Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA/AKT1/PTEN status.</li><li>Be eligible for fulvestrant and at least one out of palbociclib or ribociclib (depending on the available CDK4/6i options at time of enrolment), as per local investigator assessment.</li><li>Have measurable lesion(s) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) or, in the absence of measurable disease, lytic or mixed bone lesions that can be assessed by computed tomography (CT) or magnetic resonance imaging (MRI).</li></ol></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>for both phases:</p><ol><li>History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.</li><li>Radiotherapy within 2 weeks prior to study treatment initiation.</li><li>Major surgery or significant traumatic injury within 4 weeks of the first dose of study treatment.</li><li>Persistent toxicities (CTCAE Grade >1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, <a href="../hearing-loss" class="trial--link-to-condition-in-text">hearing loss</a> or peripheral <a href="../neuropathy" class="trial--link-to-condition-in-text">sensory neuropathy</a>) after consultation with the AstraZeneca study physician.</li><li>Spinal cord compression, <a href="../brain-cancer" class="trial--link-to-condition-in-text">brain metastases</a> or leptomeningeal metastases unless these lesions are definitively treated (eg. <a href="../radiotherapy" class="trial--link-to-condition-in-text">radiotherapy</a>, surgery) and clinically stable off steroids for management of symptoms for at least 4 weeks prior to study treatment initiation.</li><li><p>Any of the following cardiac criteria at screening:</p><p>(a). Mean resting corrected QT interval (QTcF): (i) Participants to be treated with palbociclib:: QTcF ≥ 470 ms obtained from the average of 3 consecutive (triplicate)</p><p>ECGs (ii) Participants to be treated with ribociclib: QTcF ≥ 450 ms obtained from the average of 3 consecutive (triplicate) ECGs (iii) Participants to be treated with abemaciclib (Phase Ib only): QTcF ≥ 470 ms obtained from the average of 3 consecutive (triplicate) ECGs (b). Any clinically important abnormalities in cardiac rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block) (c). Any factors that increase the risk of QTc prolongation or risk of arrhythmic events (d). Experience of any of the following procedures or conditions in the preceding 6 months: <a href="../heart-condition" class="trial--link-to-condition-in-text">coronary artery bypass graft</a>, angioplasty, vascular stent, <a href="../heart-attack" class="trial--link-to-condition-in-text">myocardial infarction</a>, <a href="../unstable-angina" class="trial--link-to-condition-in-text">unstable angina</a> pectoris, <a href="../heart-failure" class="trial--link-to-condition-in-text">congestive heart failure</a> New York Heart Association (NYHA) grade ≥ 2 (e). Uncontrolled hypotension (f) uncontrolled <a href="../high-blood-pressure" class="trial--link-to-condition-in-text">hypertension</a> (g). Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher)</p></li><li>uncontrolled or high grade or symptomatic arrhythmia and <a href="../atrial-fibrillation" class="trial--link-to-condition-in-text">atrial fibrillation</a></li><li>Any of these clinically significant abnormalities of glucose metabolism at screening: <ol><li>. <a href="../diabetes-type-1" class="trial--link-to-condition-in-text">diabetes mellitus type I</a> or type II requiring insulin treatment</li><li>. Glycated haemoglobin (HbA1c) ≥ 8.0% (63.9 mmol/mol)</li></ol></li><li>Previous allogeneic bone marrow transplant or solid organ transplant.</li></ol><p>Key exclusion criteria for the phase III only:</p><ol><li>Any prior treatment with, AKT, PI3K or mTOR inhibitors.</li><li>Prior treatment with CDK4/6 inhibitors in the metastatic setting (prior CDK4/6 inhibitors permitted in the adjuvant setting provided there was a CDK4/6i treatment free interval of at least 12 months).</li><li>More than 1 line of chemotherapy for metastatic disease</li></ol></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">Research Site</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"> 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">Research Site</span><wbr> <span class="badge badge-secondary">withdrawn</span><br><span class="location-address comma-list comma-list--without-and"><span class="comma-list-item" itemprop="addressLocality"> Santa Barbara</span><span class="comma-list-item" itemprop="addressRegion"> California</span><span class="comma-list-item" itemprop="postalCode"> 93105</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">Research Site</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/hope.rugo" target="_blank" rel="noopener author" class="trial--link-to-pi-profile">Hope Rugo</a> </strong> </span><br> Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer. </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="2021-05-10">May 2021</time></dd><dt class="col-sm-3 text-sm-right">Completion Date</dt><dd class="col-sm-9"><time datetime="2029-08-14">August 2029</time> (estimated)</dd><dt class="col-sm-3 text-sm-right">Sponsor</dt><dd class="col-sm-9">AstraZeneca</dd><dt class="col-sm-3 text-sm-right">Links</dt><dd class="col-sm-9"> <a href="https://www.breastcancerstudylocator.com/trial/listing/284051" class="trial--link-to-external-study-link d-block" target="_blank" rel="noopener ugc nofollow"><i class="fa fa-link" aria-hidden="true"></i> Breast Cancer Study Locator details (for US)</a> </dd><dt class="col-sm-3 text-sm-right">ID</dt><dd class="col-sm-9"> <a href="https://clinicaltrials.gov/study/NCT04862663" class="trial--link-to-clinicaltrials-gov" target="_blank" rel="noopener nofollow" title="ClinicalTrials.gov identifier">NCT04862663</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 895 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="2025-01-16">January 16, 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 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="NCT04862663"> <input type="hidden" name="Trial_Title" value="Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)"> <input type="hidden" name="Trial_Contact" value="53616c7465645f5f0a141e28323c465019d77e0014b006884f2c17f993809219606f33e8f319e8cca8c7ffbb9e81d077"> <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-danger font-weight-bold"></span><br> Did you mean <span id="contact-email--suggestion-email" class="text-monospace text-success font-weight-bold"></span> ? </div></div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right" for="contact-phone">Phone</label> <div class="col-sm-8 form-group--input-container"> <input name="Phone" type="tel" class="form-control form-control-lg" id="contact-phone" placeholder="Your phone (optional)" pattern=".*\d.*\d.*\d.*\d.*\d.*\d.*\d.*\d.*" minlength="8" autocomplete="tel"> </div></div><div class="form-group row"> <label class="col-sm-3 col-form-label col-form-label-lg text-sm-right">Are you human?</label> <div class="col-sm-8 form-group--input-container"><div class="g-recaptcha" id="contact-recaptcha-captcha" data-sitekey="6LfpryUTAAAAAKT_A9vSYllUZW9fS3l-SzN_dzU2"></div><p class="small mb-0">This step makes sure spammers don’t flood our inbox</p></div></div><div class="form-group row"><div class="offset-sm-3 col-sm-8"> <button type="submit" class="btn btn-primary btn-lg">Send to study team</button> </div></div></form><p class="small">We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. 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. 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