ER[+]/HER2[-] & Ki67≥10% early breast cancer (EBC)
Conditions
Brief summary
Changes in tumor cell proliferation as measured by Ki67 expression between baseline and post-treatment tumor biopsy samples by central assessment in patients with centrally confirmed Ki67 ≥10% (Arm A vs Arm B).
Detailed description
CCCA in all arms, defined as the percentage of participants with centrally assessed Ki67 scores ≤2.7% stained nuclei upon treatment (post-treatment sample)., Changes in markers (such as ER and PgR levels) and molecular profiling using HTG (PAM-like molecular test)., Incidence and severity of adverse events (AEs), with severity determined in accordance with NCI-CTCAE v.5.0., Plasma endocrine panel performed pre- and post-therapy., Expression of ER and PgR in samples pre- and post-therapy., Other exploratory studies to be determined.
Interventions
DRUGRO7197597
DRUGTAMOXIFEN
Sponsors
Medica Scientia Innovation Research S.L., Medica Scientia Innovation Research S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in tumor cell proliferation as measured by Ki67 expression between baseline and post-treatment tumor biopsy samples by central assessment in patients with centrally confirmed Ki67 ≥10% (Arm A vs Arm B). | — |
Secondary
| Measure | Time frame |
|---|---|
| CCCA in all arms, defined as the percentage of participants with centrally assessed Ki67 scores ≤2.7% stained nuclei upon treatment (post-treatment sample)., Changes in markers (such as ER and PgR levels) and molecular profiling using HTG (PAM-like molecular test)., Incidence and severity of adverse events (AEs), with severity determined in accordance with NCI-CTCAE v.5.0., Plasma endocrine panel performed pre- and post-therapy., Expression of ER and PgR in samples pre- and post-therapy., Other exploratory studies to be determined. | — |
Countries
France, Spain
Outcome results
None listed