Palbociclib plus fulvestrant in women with hormone receptor positive and human epidermal growth factor receptor type 2 negative locally advanced or metastatic breast cancer previously treated with a CDK4/6 inhibitor in combination with hormonal therapy: a multicenter, phase II trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513372-18-00

Acronym

GIM24-PALBO-BP

Enrollment

168

Registered

2024-05-29

Start date

2019-10-18

Completion date

Unknown

Last updated

2024-05-29

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

Conditions

Pre- and post-menopausal women with HR+/HER2- LABC or MBC whose disease has progressed to CDK4/6 inhibitor in combination with a hormonal therapy in the adjuvant or metastatic setting

Brief summary

To evaluate the efficacy of the combination of fulvestrant plus palbociclib at the progression of a combined treatment of hormonal therapy (aromatase inhibitor or tamoxifen ± LHRHa) and CDK4/6 inhibitors with respect to: • Overall response rate (ORR) • Progression Free Survival (PFS) • 6-month PFS rate • Overall Survival (OS) • Safety and tolerability

Detailed description

To assess predictive biomarkers of response/resistance to fulvestrant plus palbociclib using metastatic tumor tissue samples and liquid biopsies.

Interventions

DRUGIBRANCE 125 mg hard capsules

DRUGIBRANCE 125 mg film-coated tablets

DRUGIBRANCE 100 mg film-coated tablets

DRUGIBRANCE 100 mg hard capsules

DRUGIBRANCE 75 mg hard capsules

DRUGIBRANCE 75 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of the combination of fulvestrant plus palbociclib at the progression of a combined treatment of hormonal therapy (aromatase inhibitor or tamoxifen ± LHRHa) and CDK4/6 inhibitors with respect to: • Overall response rate (ORR) • Progression Free Survival (PFS) • 6-month PFS rate • Overall Survival (OS) • Safety and tolerability	—

Secondary

Measure	Time frame
To assess predictive biomarkers of response/resistance to fulvestrant plus palbociclib using metastatic tumor tissue samples and liquid biopsies.	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026