Phase II study of Letrozole combined with Cyclophosphamide and Capecitabine(LCX) for Hormone-Sensitive advanced breast cancer(age over 65) (JBCRG-14)

Phase II study of Letrozole combined with Cyclophosphamide and Capecitabine(LCX) for Hormone-Sensitive advanced breast cancer(age over 65) (JBCRG-14) - JBCRG-14

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006708

Enrollment

Registered

2011-11-18

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

Postmenopausal, ER positive and HER2 negative advanced breast cancer

Interventions

Letrozole 2.5mg p.o. daily and Cyclophosphamide 50mg p.o. daily and Capecitabine 1000mg/m2 p.o. daily for 24 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Advanced breast cancer 2. Stage:IIA, IIB, IIIA 3. Histological confirmed invasive breast cancer by biopsy 4. Estorogen receptor(ER) positive by Immunohistochemistry(IHC; => 10% or Allred score => 3). 5. HER2 negative (IHC: 1+ or 0, or FISH: negative) 6. The patient is aged 65 to 79. 7. One of the following cases 1) Histologic grade: => Grade2 2) tumor size => 5cm 3) lymph node-positive 4) Ki67 => 15% 8. Measurable region 9. Principal organs (bone marrow, heart, liver, kidneys, etc.) are functionally preserved. 1)White blood cell count => 3,000/mm3 or Neutrophil count => 1,500/mm3 2)Platelet count => 100,000/mm3 3)Hemoglobin => 9.0 g/dL 4)AST, ALT <= 1.5 x Upper limit of facility reference 5)Total bilirubin <= 1.25 x Upper limit of facility reference 6)ALP <= 1.25 x Upper limit of facility reference 7)Serum creatinine <= 1.5 x Upper limit of facility reference 10. ECOG preformance status (P.S.): 0 and 1 11. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Prior chemotherapy or endocrine therapy 2. Need for treatment with taxanes and anthracycline drug 3. need of Treatment with hormone therapy alone 4. Medication that may affect the sex hormone status (hormone replacement therapy, raloxifene, etc.) 5. History or complications of uncontrolled hypertension, severe heart disease (heart failure, ischemic heart disease, endocarditis, valvular heart disease, pericarditis, and congenital heart disease) 6. Active double cancer 7. Inflammatory breast cancer 8. Bilateral breast cancer 9. Medication of investigational new drug 10. Cases in which study participation is considered difficult due to the coexistence of psychosis or psychiatric symptoms 11. Cases considered ineligible by the attending physician for other reasons

Design outcomes

Primary

Measure	Time frame
Overall Response Rate: ORR	—

Secondary

Measure	Time frame
Pathological Complete Response: pCR Safety Breast Conserving Rate: BCR Disease-free Survival: DFS	—

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