POLAR: A phase III open-label, multicenter, randomized trial of adjuvant palbociclib in combination with endocrine therapy versus endocrine therapy alone for patients with hormone receptor positive / HER2-negative resected isolated locoregional recurrence of breast cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510776-20-00

Acronym

IBCSG 59-19

Enrollment

381

Registered

2024-04-04

Start date

2019-10-25

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Female or male patients with histologically confirmed HR-positive, HER2-negative resected isolated locoregional recurrence (ILRR) of breast cancer.

Brief summary

The primary endpoint iDFS is defined as duration of time from randomization until first appearance of invasive local, regional, or distant recurrence (including invasive ipsilateral breast tumor recurrence), invasive contralateral breast cancer, a second (non-breast) invasive cancer, or death from any cause.

Detailed description

The secondary endpoints are: - Adverse events, according to CTCAE version 5 - Breast cancer-free interval (BCFI) - Distant recurrence-free interval (DRFI) - Overall survival (OS)

Interventions

DRUGIBRANCE 125 mg film-coated tablets

DRUGIBRANCE 100 mg film-coated tablets

DRUGIBRANCE 75 mg film-coated tablets

DRUGIBRANCE 75 mg hard capsules

DRUGIBRANCE 125 mg hard capsules

DRUGIBRANCE 100 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint iDFS is defined as duration of time from randomization until first appearance of invasive local, regional, or distant recurrence (including invasive ipsilateral breast tumor recurrence), invasive contralateral breast cancer, a second (non-breast) invasive cancer, or death from any cause.	—

Secondary

Measure	Time frame
The secondary endpoints are: - Adverse events, according to CTCAE version 5 - Breast cancer-free interval (BCFI) - Distant recurrence-free interval (DRFI) - Overall survival (OS)	—

Countries

Austria, France, Hungary, Italy, Spain

Outcome results

None listed

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