ELACESTRANT for Early breast cancer | Estrogen receptor-positive breast cancer | HER2-negative breast cancer | Node-positive breast cancer

Inclusion criteria

• {"criterion_text":"-Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0 or 1, or (IHC = 2 and in situ hybridization [ISH] negative)] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines."}
• {"criterion_text":"-Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK4/6i and with or without an LHRH agonist. Participants who received prior CDK4/6i or a poly ADP-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments."}

Exclusion criteria

• {"criterion_text":"-Participants with inflammatory breast cancer."}
• {"criterion_text":"-History of any prior (ipsilateral and/or contralateral) invasive breast cancer."}
• {"criterion_text":"-Participants who had more than 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization."}

Primary endpoints

• {"endpoint_text":"-IBCFS: the time from date of randomization to the date of first occurrence of: •\\tipsilateral invasive breast tumor recurrence, •\\tlocal/regional invasive breast cancer recurrence, •\\tdistant recurrence, •\\tcontralateral invasive breast cancer, or •\\tdeath attributable to any cause.","definition_or_measurement_approach":"Time from randomization to first occurrence of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause (as defined in protocol)."}

Secondary endpoints

• {"endpoint_text":"-DRFS: the time from randomization to distant recurrence or death from any cause, whichever occurred first.","definition_or_measurement_approach":"Time from randomization to distant recurrence or death from any cause, whichever occurs first."}
• {"endpoint_text":"-OS: the time from randomization to death from any cause.","definition_or_measurement_approach":"Time from randomization to death from any cause."}
• {"endpoint_text":"-IDFS: the time from randomization to the first occurrence of local or regional recurrence, contralateral recurrence, second primary non-breast invasive cancer, distant recurrence, or death attributable to any cause.","definition_or_measurement_approach":"Time from randomization to first occurrence of local/regional recurrence, contralateral recurrence, second primary non-breast invasive cancer, distant recurrence, or death from any cause."}
• {"endpoint_text":"-Adverse events (AEs), treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as well as changes in clinical laboratory values and vital sign measurements.","definition_or_measurement_approach":"Standard safety assessments: reporting and coding of AEs, TEAEs, SAEs; clinical laboratory and vital sign changes per protocol schedules."}
• {"endpoint_text":"-Change from baseline in the global health status quality of life scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 global health status score at specified timepoints (6 and 12 months and annually thereafter)."}
• {"endpoint_text":"-Change from baseline in the physical functioning sub-scale score at 6 and 12 months and annually thereafter, as assessed by EORTC QLQ-C30.","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 physical functioning sub-scale score at specified timepoints."}
• {"endpoint_text":"-Change from baseline in the breast cancer Endocrine Therapy Symptoms sub-scale score at 6 and 12 months and annually thereafter, as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR42).","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-BR42 endocrine therapy symptoms sub-scale score at specified timepoints."}
• {"endpoint_text":"-Change from baseline in side effects/tolerability at 6 and 12 months and annually thereafter, as assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168).","definition_or_measurement_approach":"Change from baseline in response to EORTC Q168 Question 168 at specified timepoints."}
• {"endpoint_text":"-Elacestrant PK parameters, exposure-response analyses between elacestrant PK and efficacy/safety endpoints.","definition_or_measurement_approach":"Characterization of steady-state PK parameters and exposure-response analyses (PK vs efficacy/safety) in subset of participants (US clinical sites as specified)."}

Methods

• Country-specific recruitment websites (documents titled 'Recruitment Website' and associated Cookie/Privacy policies) — used in multiple countries (examples: Sweden, Belgium, Italy, Spain, Germany, Netherlands, Portugal, Poland, Finland).
• Printed materials at sites: posters and brochures (country-specific recruitment posters and brochures are provided for many countries, e.g., Belgium, Sweden, Hungary, Italy, France, Poland, Finland, Netherlands, Portugal, Spain).
• Digital channels and social media: digital toolkits, social media toolkits and online recruitment toolkits (country-specific digital recruitment materials present for several countries).
• Healthcare professional outreach: 'Dear Colleague' letters and referral cards (e.g., Hungary listings for GP/HCP letters).
• Recruitment procedure descriptions in English and country languages (documents titled 'Recruitment Procedure Description').

Primary sponsor

Full Name

Stemline Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International Corp.

Responsibilities

Operational and regulatory support (multiple sponsor duties coded in record)

Name

Medidata Solutions Inc.

Responsibilities

eCRF (electronic data capture)

Name

Cytel Inc.

Responsibilities

iDMC

Name

Phlexglobal Limited

Responsibilities

Sponsor's eTMF

Name

JMAC

Responsibilities

Manage prebooked patient travel/lodging; reimburse travel expenses for participants

Third parties

• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"iDMC","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"JMAC","duties_or_roles":"Manage prebooked patient travel/lodging; reimburse self-booked travel expenses for participants only","organisation_type":"Health care"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCRF","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Italy","full_name":"Menarini Ricerche S.p.A.","duties_or_roles":"Central Lab: PK (plasma and CFS); Central Lab: responsible for analysis cfNA, cfNA (CFS); Clinical Sciences","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Phlexglobal Limited","duties_or_roles":"Sponsor's eTMF","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Multiple duties (codes present) — contact/oversight/regulatory and operational support (detailed codes listed in source)","organisation_type":"Non-Pharmaceutical company"}