Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)
- Conditions
- Estrogen Receptor-positive Breast CancerMetastatic Breast CancerBreast Cancer
- Interventions
- Registration Number
- NCT04571437
- Lead Sponsor
- Cairo University
- Brief Summary
A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.
- Detailed Description
This is a randomized clinical trial that assigns patients with female breast cancer in the metastatic entity or advanced -beyond local disease treatment - entity into two arms. Arm A contains Letrozole with metronomic Capecitabine versus arm B that contains Letrozole alone. This is to be applied on ER positive HER2 negative tumours.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 204
- Female sex
- Age 18-70
- ECOG-PS 0-II.
- Histopathological proof of breast cancer
- ER positive (Allred score of ≥3 out of 8), and HER2 negative by IHC (or ISH if HER2 +2).
- Metastatic/recurrent disease as proven by CT scan, bone scan or clinical examination (for skin lesions). Biopsy of the recurrent lesions is encouraged but not mandatory.
- Either hormone sensitive setting (Denovo metastatic disease or disease progression after more than 1 year of ending adjuvant endocrine therapy) or secondary resistance to tamoxifen therapy (disease relapse after more than 2 years of starting and less than 1 year of ending adjuvant endocrine therapy, or DP of metastatic disease after more than 6 months of first line tamoxifen).
- Adequate organ function.
- Signed informed consent
Exclusion criteria:
- Inadequate organ functions.
- Disease progression while on prior aromatase inhibitor therapy.
- Primary endocrine resistance.
- Double primary cancer (history of other malignancy apart from a non melanoma skin cancer).
- Refusal to sign consent.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endocrine treatment only (B) Letrozole 2.5mg Letrozole 2.5mg PO daily Chemo endocrine treatment (A) Letrozole 2.5mg Letrozole 2.5mg PO daily + Capecitabine 500mg/m2 bid PO continously Chemo endocrine treatment (A) Capecitabine Letrozole 2.5mg PO daily + Capecitabine 500mg/m2 bid PO continously
- Primary Outcome Measures
Name Time Method 6 months Progression free survival rate 6 months from the start of treatment Percentage of patients alive and progression-free at 6 months
- Secondary Outcome Measures
Name Time Method Quality of life assessment using FACIT-B questionnare 6 months FACIT-B questionnare will be completed by each patient at baseline and 6 months after randomization
Time to treatment failure 18 months Time from start treatment to progression, death or treatment discontinuation from any cause
Overall survival 24 months Percentage of patients alive at 24 months
Time to chemotherapy adminstration 18 months Time from randomization to the first chemotherapy administration
Overall response rate 6 months from the start of treatment Rate of CR+PR as assessed by the investigator using RECIST 1.1 criteria
Adverse events rates in both groups 6 months from the start of treatment Rates of all grade (grade 1-4) and high grade (grade 3+4) adverse events as assessed by NCI-CTAE v4.0
Median progression free survival 18 months comparison of estimated median PFS between both groups
Clinical benefit rate After 6 months of treatment Complete response + partial response + stable disease for 6 months
Trial Locations
- Locations (1)
Faculty of Medicine, Cairo University
🇪🇬Cairo, Egypt