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J6M-MC-JSGD: A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tersolisib (LY4064809) Combined with a CDK4/6 Inhibitor and Endocrine Therapy in Adults with HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522791-92-00
Enrollment
36
Registered
2026-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm Metastasis, Breast Neoplasms

Brief summary

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, Part 2: Progression-Free Survival [Time Frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)] Investigator-assessed

Interventions

DRUGPALBOCICLIB
DRUGEXEMESTANE
DRUGTERSOLISIB
DRUGLETROZOLE
DRUGFULVESTRANT
DRUGabemaciclib
DRUGANASTROZOLE
DRUGto match Tersolisib (LY4064809)
DRUGRIBOCICLIB

Sponsors

Eli Lilly & Co.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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, Part 2: Progression-Free Survival [Time Frame: Baseline to objective progression or death due to any cause (Estimated up to 5 years)] Investigator-assessed

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 25, 2026