Observational study for evaluation of effecacy and safety of ethinylestradiol therapy for postmenopausal hormone receptor-positive metastatic breast cancer patients heavily pre-treated with endocrine treatment

Observational study for evaluation of effecacy and safety of ethinylestradiol therapy for postmenopausal hormone receptor-positive metastatic breast cancer patients heavily pre-treated with endocrine treatment - EE2 Observational Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010492

Enrollment

Registered

2013-04-14

Start date

2012-11-13

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

Breast Cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. The case from which informed consent is obtained in written form 2. Primary lesion was histologically diagnosed by biopsy and/or cytology 3. Postmenopausal patient 4. Heavily pre-treated with several endocrine treatment a. Heavily pre-treated with several aromatase inhibitors in adjuvant and metastatic setting b. Heavily pre-treated with several aromatase inhibitors and anti-estrogens in adjuvant and metastatic setting c. whether or not used chemotherapy during prior treatemt in above case a and b 5. Not used chemotherapy before entry this observational study after the latest endocrine therapy 6. The case which has meaurable lesion or osteolytic/mixed bone metastasis 7. Estrogen receptor-positive breast cancer 8. The case from which the survival for six months or more is expected 9. Performance status is 0 or 1. If the patients have bone metastasis, PS 2 are acceptable 10. The case with which the organs function is held enough and the case by which the following conditions are fulfilled a. Hemogrobine: 8 g/dl or more b. AST/ALT: 2.5 or less times of the normal value maximum in participating institution c. BUN: 25 mg/dl or less d. serum creatinin: 1.5mg/dl or less

Exclusion criteria

Exclusion criteria: 1. History of deep vain thrombosis, myocardial infarction and brain infarction 2. Active double cancer, history of endometrial cancer and History of other cancer within 5 years (exclued in-situ cervical cancer, basal cell carcinoma and squamous cell carcinoma of the skin) 3. HER2-positive breast cancer 4. Bilateral breast cancer 5. inflamatory breast cancer 6. History of sever drug hypersensitivity 7. pregnant or nursing female 8. life-threatening metastatic breast cancer 9. The case which the family doctor judged to be unsuitable for the object of the study

Design outcomes

Primary

Measure	Time frame
Clinical benefit rate	—

Secondary

Measure	Time frame
Objective response rate, progression-free survival, adverse events, endocrine-related symptoms	—

Countries

Japan

Contacts

Public ContactYutaka Yamamoto

Kumamoto University Hospital Department of Molecular-Targeting Therapy for Breast Cancer

ys-yama@triton.ocn.ne.jp096-373-5521

Outcome results