{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.\" This guidance is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant (preoperative) setting using pathological complete response (pCR) as a surrogate endpoint that could support approval under the accelerated approval regulations. Despite advances in systemic therapy of early-stage breast cancer over the past few decades, there remains a significant unmet medical need for certain high-risk or poor prognosis populations of early-stage breast cancer patients. This guidance is intended to encourage industry innovation and expedite the development of breakthrough therapies to treat high-risk early-stage breast cancer. This guidance finalizes the draft guidance issued May 30, 2012.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/10/07/2014-23845.html","cfr_references":[],"citation":"79 FR 60476","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0432"],"dockets":[],"document_number":"2014-23845","effective_on":null,"end_page":60477,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/10/07/2014-23845.xml","html_url":"https://www.federalregister.gov/documents/2014/10/07/2014-23845/pathological-complete-response-in-neoadjuvant-treatment-of-high-risk-early-stage-breast-cancer-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-23845?publication_date=2014-10-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-10-07/2014-23845/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":969,"last_updated":"2026-05-23 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-10-07/pdf/2014-23845.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-23845.pdf?1412599509","publication_date":"2014-10-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/10/07/2014-23845.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-D-0432","supporting_documents_count":0,"docket_id":"FDA-2012-D-0432","regulation_id_number":null,"title":"Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval; Availability","checked_regulationsdotgov_at":"2015-01-12T19:44:01Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60476,"subtype":null,"title":"Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated Approval; Guidance for Industry; Availability","toc_doc":"Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast CancerUse as an Endpoint to Support Accelerated Approval","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}