PREDIX Luminal B - Neoadjuvant response-guided treatment of estrogen receptor positive tumors with high proliferation or slow proliferation with metastatic nodes. Part of a platform of translational phase II trials based on molecular subtypes.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519019-32-00

Acronym

PREDIX LumB

Enrollment

180

Registered

2024-10-28

Start date

2014-12-05

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

Early breast cancer

Brief summary

Absolute difference in clinical and radiological objective response after completion of the first 12-week period of primary medical treatment

Detailed description

Pathological objective response to primary medical treatment, Sequencing of chemotherapy versus endocrine treatment plus palbociclib, Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer, Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS), Safety, Quality of life, Frequency of breast-conserving surgery

Interventions

DRUGTAMOXIFEN SANDOZ 20 mg

DRUGExemestan Sandoz 25 mg

DRUGfilmdragerade tabletter

DRUGAnastrozol Sandoz 1 mg filmdragerade tabletter

DRUGIBRANCE 125 mg film-coated tablets

DRUGLetrozole Sandoz 2

DRUG5 mg filmdragerade tabletter

DRUGPaclitaxel Accord 6 mg/ml koncentrat till infusionsvätska

DRUGlösning

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute difference in clinical and radiological objective response after completion of the first 12-week period of primary medical treatment	—

Secondary

Measure	Time frame
Pathological objective response to primary medical treatment, Sequencing of chemotherapy versus endocrine treatment plus palbociclib, Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer, Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS), Safety, Quality of life, Frequency of breast-conserving surgery	—

Measure

Time frame

—

Countries

Sweden

Outcome results

None listed

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