Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)

Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05) - JBCRG-05

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001214

Enrollment

Registered

2008-06-27

Start date

2007-08-01

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 and Docetaxel 75mg/m2 x 4 courses

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. 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 5. Postmenopausal women when receiving the anthracycline-containing chemotherapy 6. Measurable region 7. 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 EF >= 60% 8. ECOG preformance status (P.S.): 0 and 1 9. Age: <= 70 10. Possible to provide the biopsy specimens, isolated tissues and blood samples for this study. 11. 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. Neuropathy 7. Edema 8. Inflammatory breast cancer 9. Bilateral breast cancer 10. History of drug-hypersensitivity 11. Under treatment of continuous systematic steroids, estrogen and raloxifene 12. Serious mental disease 13. 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