Phase II study of Neoadjuvant Letrozole for Postmenopausal Women with Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-06)

Phase II study of Neoadjuvant Letrozole for Postmenopausal Women with Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-06) - JBCRG-06

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001325

Enrollment

Registered

2008-09-01

Start date

2007-10-01

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

Postmenopausal, hormone-receptor positive and primary breast cancer

Interventions

Letrozole 2.5mg daily for 12 weeks to 18 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Operable primary breast cancer(T1c-3 N0 M0 / T1-3 N1 M0: at first diagnosis). 2. Histological confirmed invasive breast cancer by biopsy. 3. Estorogen receptor(ER) and/or Progesterone receptor(PgR) positive by Immunohistochemistry(IHC; >=10%). 4. HER2 <= 2+ or FISH negative 5. All of the following patients that received 2-4 cycles of anthracycline-containing regimen. i) SD/PD on CT/MRI confirmed by RECIST ii) >=75% relative dose intensity in one of the following regimens; FEC75-100, AC 60/600, EC 75-90/600 iii) SD >= 3 cycles, PD >= 2 cycles 6. Postmenopausal women when receiving the anthracycline-containing chemotherapy 7. Measurable region 8. Adequate major organ function; WBC >= 3,000/mm3 <= 12,000/mm3 or ANC >= 1,500/mm3 PLT >= 100,000/mm3 Hb >= 9.6 g/dl AST, ALT <= 1.5 x ULN T. Bil <= 1.25 x ULN Serum Cr. <= 1.5 Nomal ECG 9. ECOG preformance status (P.S.): 0 and 1 10. Age: <= 75 11. Possible to provide the biopsy specimens, isolated tissues and blood samples for this study. 12. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Unmanageable serious complications 2. HCV 3. Unmanageable diabetes 4. Suspicious infection with fever 5. Active double cancer 6. Inflammatory breast cancer 7. Bilateral breast cancer 8. 10. History of drug-hypersensitivity 9. Receiving continuous systematic steroids, estrogen and Raloxifene 10. Mental disease 11. Patient judged inappropriate for this study by the physicians

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Pathological CR rate, Breast Conserving Surgery rate, Safety, Disease- free survival and Overall survival	—

Countries

Japan

Contacts

Public ContactKatsumasa Kuroi

Japan Breast Cancer Research Group (JBCRG) Head Office

office@jbcrg.jp03-6264-8873

Outcome results

None listed

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