Phase II study of efficacy of letrozole in postmenopausal patients with endocrine-responsive, HER2-negative metastatic breast cancer resistant to exemestane or anastrozole.

Phase II study of efficacy of letrozole in postmenopausal patients with endocrine-responsive, HER2-negative metastatic breast cancer resistant to exemestane or anastrozole. - SBP-02

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006667

Enrollment

Registered

2011-11-04

Start date

2011-11-01

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

Metastatic breast cancer

Interventions

EL: Letrozole(2.5 mg Tablet) is administered orally once a day for endocrine-responsive, HER2-negative metastatic breast cancer patients in postmenopausal women with tumor which has relapsed or progre

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients who provided written informed consent by themselves in principle to participate in this trial. 2. Patients with a performance status (ECOG) of 2-0. 3. Patients who confirmed to be Amenorrhea past 1 year. 4. Patients whom the primary or metastatic lesion was confirmed to be breast cancer by histological examination. 5. Patients whom the primary or metastatic lesion was confirmed to be ER-positive and HER2-negative.Except for IHC 2+/not tested FISH 6. Patients with measurable metastatic by RECIST ver1.1 7. Patients who showed recurrence during or after treatment within 1 year of exemestane or anastrozole. 8. Patients with no history of treatment by letrozole.EL: Patients with no history of treatment by anastrozole.(AL: Does not matter for history of treatment by exemestane.) 9. Patients expected to survive for 3 months or more. 10. Patients who satisfies the following organ function. (Using the latest Laboratory parameters within 30 days prior to enrollment.) WBC: >= 2,000/mm3 or Neu: >= 1,000/mm3 Hb: >= 9.0g/dL Plt: >= 100,000/mm3 T-Bil: <= 2 times ULN(upper limit of normal) AST and ALT: <= 2 times ULN Creatinin: <= 2 times ULN

Exclusion criteria

Exclusion criteria: 1. Patients with active other malignancies.(other simultaneity malignancies and other heterochrony malignancies within 5 years disease-free interval) *Except patients who cured carcinoma in situ or intramucosal carcinoma by local treatment. 2. Patients with brain metastasis with symptom. 3. Patients who confirmed to be unstable angina pectoris, congestive heart failure, myocardial infarction, myocardial infarction, ventricular arrhythmia that need treat within 6 months before register. 4. Patients who confirmed to be uncontrollable hypertension, diabetes when you register. 5. Patients with severe infectious disease. 6. Patients with severe complications 7. Patients who are receiving bisphosphonates for hypercalcemia by malignancy.(Except patients who had receiving bisphosphonates for osteoporosis, bone metastases.) 8. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.

Design outcomes

Primary

Measure	Time frame
Clinical benefit rate	—

Secondary

Measure	Time frame
Response rate, Time to progression, Overall survival, Safety	—

Countries

Japan

Contacts

Public ContactTadahiko Shien

Setouchi Breast Project Comprehensive Organization Clinical Research Group

086-235-7265

Outcome results

None listed

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