EORTC-1745-ETF-BCG: A Phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cancer (APPALACHES)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505223-31-00

Acronym

EORTC-1745-ETF-BCG

Enrollment

347

Registered

2024-02-21

Start date

2019-06-14

Completion date

Unknown

Last updated

2025-09-03

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

Conditions

Localized ER+ breast cancer

Brief summary

The primary endpoint in this study is the 3-year distant recurrence-free interval rate in the experimental arm.

Detailed description

Distant recurrence-free interval at 3 years in the control arm., Breast cancer specific survival at 3 years in both arms., Overall survival at 3 years in both arms., Adverse events according to CTCAE v5.0 recorded at every patient visit in both arms., Treatment discontinuation and dose reduction rates in both arms., Reason for treatment discontinuation., HRQoL questionnaires (modified QLQ-C30, ELD-14, and selected items from the BR45 module) at 3 months, 6 months, 1 year, 2 years, and 3 years in both arms., Geriatric assessment tools (G8, iADL, ADL, Gait speed, CCI, social situation) at 3 months, 6 months, 1 year, 2 years, and 3 years in both arms.

Interventions

DRUGIBRANCE 125 mg hard capsules

DRUGTAMOXIFEN

DRUGIBRANCE 75 mg hard capsules

DRUGIBRANCE 100 mg hard capsules

DRUGDOCETAXEL

DRUGANASTROZOLE

DRUGIBRANCE 100 mg film-coated tablets

DRUGEXEMESTANE

DRUGIBRANCE 125 mg film-coated tablets

DRUGEPIRUBICIN HYDROCHLORIDE

DRUGPACLITAXEL

DRUGLETROZOLE

DRUGDOXORUBICIN

DRUGCYCLOPHOSPHAMIDE

DRUGIBRANCE 75 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint in this study is the 3-year distant recurrence-free interval rate in the experimental arm.	—

Secondary

Measure	Time frame
Distant recurrence-free interval at 3 years in the control arm., Breast cancer specific survival at 3 years in both arms., Overall survival at 3 years in both arms., Adverse events according to CTCAE v5.0 recorded at every patient visit in both arms., Treatment discontinuation and dose reduction rates in both arms., Reason for treatment discontinuation., HRQoL questionnaires (modified QLQ-C30, ELD-14, and selected items from the BR45 module) at 3 months, 6 months, 1 year, 2 years, and 3 years in both arms., Geriatric assessment tools (G8, iADL, ADL, Gait speed, CCI, social situation) at 3 months, 6 months, 1 year, 2 years, and 3 years in both arms.	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Italy, Poland, Portugal, Spain

Outcome results

None listed

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