Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513540-29-00

Acronym

AFT-38

Enrollment

303

Registered

2024-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

Breast Cancer

Brief summary

Progression-free survival (PFS) as assessed by the Investigator

Detailed description

Overall Survival (OS), 3-year and 5-year survival probabilities, Objective response (OR: CR or PR), Duration of response (DOR), Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks), Incidence of CNS metastasis, Safety: Type, incidence, severity (as graded by the NCI CTCAE v. 4.0), seriousness and attribution to the study medications of AEs and any laboratory abnormalities, Patient Reported Outcomes: Time to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status

Interventions

DRUGIBRANCE 125 mg hard capsules

DRUGIBRANCE 75 mg hard capsules

DRUGTRASTUZUMAB

DRUGTRIPTORELIN

DRUGIBRANCE 100 mg hard capsules

DRUGGOSERELIN

DRUGPERTUZUMAB

DRUGFULVESTRANT

DRUGANASTROZOLE

DRUGLETROZOLE

DRUGEXEMESTANE

DRUGLEUPRORELIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) as assessed by the Investigator	—

Secondary

Measure	Time frame
Overall Survival (OS), 3-year and 5-year survival probabilities, Objective response (OR: CR or PR), Duration of response (DOR), Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks), Incidence of CNS metastasis, Safety: Type, incidence, severity (as graded by the NCI CTCAE v. 4.0), seriousness and attribution to the study medications of AEs and any laboratory abnormalities, Patient Reported Outcomes: Time to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status	—

Measure

Time frame

—

Countries

France, Germany, Italy, Portugal, Spain

Outcome results

None listed

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