TERSOLISIB HEMIHYDRATE for Hormone receptor-positive HER2-negative advanced breast cancer | Metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist."}
• {"criterion_text":"- If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist."}
• {"criterion_text":"- Have histologically or cytologically confirmed breast cancer"}
• {"criterion_text":"- Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay."}
• {"criterion_text":"- Have measurable disease or non-measurable, evaluable bone disease"}
• {"criterion_text":"- Part 1: Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. Up to 1 of these prior systemic treatments may contain chemotherapy"}
• {"criterion_text":"- Part 2: Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease. Individuals who are eligible are either Population 1 (P1): Endocrine sensitive newly diagnosed with advanced breast cancer (de novo) relapsed with documented evidence of progression greater than (>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, or Population 2 (P2): Endocrine resistant relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor. if a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be >12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy."}

Exclusion criteria

• {"criterion_text":"- Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter [mmol/L]), or requiring insulin."}
• {"criterion_text":"- Have inflammatory or metaplastic breast cancer."}
• {"criterion_text":"- History of leptomeningeal disease or carcinomatous meningitis."}
• {"criterion_text":"- Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization."}

Primary endpoints

• {"endpoint_text":"- Part 1: Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) [Time Frame: Baseline through disease progression or death (Estimated up to 5 years)] As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1","definition_or_measurement_approach":"Investigator-determined ORR based on RECIST v1.1; time frame baseline through disease progression or death (estimated up to 5 years)."}
• {"endpoint_text":"- Part 2: Progression-Free Survival [Time Frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)] Investigator-assessed","definition_or_measurement_approach":"Investigator-assessed progression-free survival from baseline to objective progression or death (estimated up to 5 years)."}

Methods

• Site-based recruitment at participating hospitals and oncology clinics in the listed Member States (site contacts provided).
• Use of printed recruitment materials (posters and brochures) in multiple languages (documents listed: K2 recruitment material posters and brochures in BEFR, BEDU, ENG, GR, IT etc).
• Study participant contact cards and patient-facing brochures (documents L2 Study Participant Contact Card and other subject information materials listed).
• Recruitment and Printed Study Supplies/Recruitment and Retention support provided by third parties (e.g., The Hibbert Co. listed with role 'Printed Study Supplies/Recruitment and Retention').
• A 'K1_Informed consent and Patient Recruitment Procedure' document is listed (site recruitment procedure template).

Belgium

Earliest CTIS Part Ii Submission Date

06-03-2026

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

20

Number Of Sites

7

Number Of Participants

25

France

Earliest CTIS Part Ii Submission Date

17-02-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

41

Number Of Sites

12

Number Of Participants

41

Germany

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

18

Number Of Sites

21

Number Of Participants

40

Italy

Earliest CTIS Part Ii Submission Date

06-01-2026

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

77

Number Of Sites

13

Number Of Participants

36

Spain

Earliest CTIS Part Ii Submission Date

12-02-2026

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

43

Number Of Sites

34

Number Of Participants

100

Greece

Earliest CTIS Part Ii Submission Date

16-12-2025

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

102

Number Of Sites

13

Number Of Participants

32

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD International Holdings LLC

Responsibilities

sponsorDuties code: 4 (as listed)

Name

Pharmaceutical Product Development LLC (PPD)

Responsibilities

sponsorDuties code: 4 (as listed)

Name

Icon Clinical Research LLC / Icon Clinical Research Limited

Responsibilities

sponsorDuties code: 4; training (code:15 for ICON limited)

Name

IQVIA RDS Inc.

Responsibilities

sponsorDuties codes: 1,12,2 (as listed)

Third parties

• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: 6,7; contact: CDMS_Support@veeva.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties code: 4; contact: robin.bushnell@Q2LabSolutions.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Tempus Compass LLC","duties_or_roles":"sponsorDuties code: 4; contact: robert.larsen@tempus.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties code: 15 (Clinical Trial Reimbursement); contact: kristen.carver@lilly.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"sponsorDuties code: 15 (Printed Study Supplies/Recruitment and Retention); contact: gates_jeffrey@network.lilly.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC (second entry)","duties_or_roles":"sponsorDuties code: 4; contact: robin.bushnell@Q2LabSolutions.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties code: 4; contact: kathy.dick@thermofisher.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Florence Healthcare Inc","duties_or_roles":"sponsorDuties code: 6; contact: support@florencehc.com","organisation_type":"Health care"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties code: 15 (Training); contact: selby_toni@lilly.com","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"sponsorDuties codes: 1,12,15 (Negotiation and Execution of Clinical Trial Agreements...); contact: clinops@lilly.gr","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Tier 1 Impact Pbc Inc.","duties_or_roles":"sponsorDuties code: 15 (Training); contact: sherman_kristen@lilly.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties code: 6; contact: cbowersvahed@rws.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4; contact: rhonda.orem@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP (second entry)","duties_or_roles":"sponsorDuties code: 4; contact: lindsay.eaton@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"sponsorDuties code: 4; contact: johnda.snyder@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Wuxi Apptec Co. Ltd.","duties_or_roles":"sponsorDuties code: 4; contact: LAN_LI@wuxiapptec.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code: 4; contact: roberta.ferreira@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: 1,12,2; contact: els.vannylen@iqvia.com","organisation_type":"Pharmaceutical company"}