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Prospective study of NEOadjuvant Anastrozole and RadioTherapy for hormone-responsive postmenopausal breast cancer (NEO-A-RT)

Prospective study of NEOadjuvant Anastrozole and RadioTherapy for hormone-responsive postmenopausal breast cancer (NEO-A-RT) - Prospective study of NEOadjuvant Anastrozole and RadioTherapy for hormone-responsive postmenopausal breast cancer (NEO-A-RT)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002266
Enrollment
35
Registered
2009-07-29
Start date
2009-07-21
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

early breast cancer

Interventions

Patients will receive anastrozole 1mg daily for 24 weeks and receive radiotherapy (50Gy / 25 fr) at 13 weeks from the start of anastrozole. Patients will receive surgery at 24 weeks.

Sponsors

Osaka Medical Center for Cancer and Cardiovascular Diseases
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Postmenopausal patients with biopsy-proven invasive breast cancer 2) TNM classification: T2 (3cm and larger)-T4, N0-2, M0 3) ER-positive tumor (10% or more positively staining by immunohistochemistry) 4) PS (ECOG): 0 or 1 5) Normal bone marrow, liver and renal function 6) Patients who have never received any treatment for breast cancer 7) Written informed consent is obtained

Exclusion criteria

Exclusion criteria: 1) past history of any invasive malignancy within the previous 5 years 2) past history of breast cancer or synchronous bilateral breast cancer 3) past history of radiotherapy for ipsilateral breast 4) Suspicious of allergy for radiotherapy 5) Past use of aromatase inhibitors 6) Suspicious of allergy for aromatase inhibitors 7) Patients who had received or are receiving any steroids, estrogens or selective estrogen receptor modulators 8) Any reason the physician believes that the patient is not appropriate to participate in the study

Design outcomes

Primary

MeasureTime frame
Clinical response rate

Countries

Japan

Contacts

Public ContactMakoto Ishitobi

Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Breast and Endocrine Surgery

isitobi-ma@mc.pref.osaka.jp06-6972-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026