Preoperative Image guided Accelerated Partial Breast Irradiation (PAPBI) in elderly women with early stage Breast cancer; defining radiotherapy sensitivity

Preoperative Image guided Accelerated Partial Breast Irradiation (PAPBI) in elderly women with early stage Breast cancer; defining radiotherapy sensitivity - Preoperative partial breast irradiation: defining RT sensitivity

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32678

Enrollment

Registered

2009-02-06

Start date

2010-04-13

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Breast cancer mammary malignancy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients >=60 years of age with proven adenocarcinoma of the breast presenting with an unifocal lesion on mammogram and MRI (no diffuse microcalcifications), tumor size 1.0-3.0 cm.

Exclusion criteria

Exclusion criteria: age

Design outcomes

Primary

Measure	Time frame
mRNA gene expression profiles, miRNA expression profiles and DNA copy number changes associated with response to radiotherapy defined as pathologic response assessed in the lumpectomy 6 weeks after radiotherapy will be identified. 60 Patients will be studied as a test set to identify predictive profiles. Responders are defined as Complete Respons and >50% Partial Response 6 weeks after radiotherapy. It is estimated, based on literature, that 50% of the patients will be defined responders. 60 Patients will be studied as a test set to identify predictive profiles; 60 patients will be used as a validation set.	—

Measure

Time frame

mRNA gene expression profiles, miRNA expression profiles and DNA copy number changes associated with response to radiotherapy defined as pathologic response assessed in the lumpectomy 6 weeks after radiotherapy will be identified. 60 Patients will be studied as a test set to identify predictive profiles. Responders are defined as Complete Respons and >50% Partial Response 6 weeks after radiotherapy. It is estimated, based on literature, that 50% of the patients will be defined responders. 60 Patients will be studied as a test set to identify predictive profiles; 60 patients will be used as a validation set.

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Secondary

Measure	Time frame
Cosmetic evaluation will take place including digital photographs which will be analyze using computer software as well as questionnaires for the patient and treating physician. Quality of life questionnaires.	—

Countries

Netherlands

Outcome results