Phase II trial of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients

Phase II trial of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients - AIR-EE2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015698

Enrollment

Registered

2014-11-17

Start date

2014-12-01

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

aromatase inhibitor-resistant advanced/recurrent breast cancer

Interventions

Ethinylestradiol 3mg will be given orally everyday for 28 days. Three cycle of ethinylestradiol will be given.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed breast cancer 2. Postmenopausal women with ER positive or PgR positive breast cancer 3. Measurable primary/metastatic lesion 4. Inoperable or metastatic breast cancer 5. Performance status 0, 1 or 2 6. Aromatase inhibitor-resistant 7. A case without severe complications and also meets the requirements below 1) WBC; more than 3,500/mm3, less than 10,000/mm3, Plt; more than 100,000/mm3, Hb; more than 10g/dl 2) T-Bil.; less than 1mg/dl, GOT; less than 60 IU/L, GPT; less than 60 IU/L 8. With written informed consent

Exclusion criteria

Exclusion criteria: 1. Inflammatory breast cancer 2. Any malignant neoplasms 3. Severe cardiac disease(e.g. myocardial infarction, valvular disease, heart failure) 4. Liver cirrhosis 5. Thrombosis 6. Judged inappropriate by physicians

Design outcomes

Primary

Measure	Time frame
Response Rate; RR	—

Secondary

Measure	Time frame
Clinical Benefit Rate; CBR Adverse Drug Reaction; ADR Progression-Free Survival; PFS	—

Countries

Japan

Contacts

Public ContactTakamichi Yokoe

Keio University School of Medicine Department of Surgery

yokoe@z2.keio.jp03-3353-1211

Outcome results

None listed

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