Breast Cancer, Estrogen Receptor-positive Breast Cancer, Metastatic Breast Cancer
Conditions
Keywords
Advanced breast cancer, chemo-hormonal, hormone positive, metronomic capecitabine
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.
Interventions
DRUGCapecitabine
Capecitabine metronomic combined with Letrozole
DRUGLetrozole 2.5mg
Letrozole daily alone
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are assigned into two arms of treatment, arm A contains Letrozole and metronomic Capecitabine while arm B contains Letrozole alone.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 months Progression free survival rate | 6 months from the start of treatment | Percentage of patients alive and progression-free at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Median progression free survival | 18 months | comparison of estimated median PFS between both groups |
| Overall response rate | 6 months from the start of treatment | Rate of CR+PR as assessed by the investigator using RECIST 1.1 criteria |
| Clinical benefit rate | After 6 months of treatment | Complete response + partial response + stable disease for 6 months |
| 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 |
| Time to treatment failure | 18 months | Time from start treatment to progression, death or treatment discontinuation from any cause |
Countries
Egypt
Contacts
Primary ContactMariam Saleh, M.D
Backup ContactLoay Kassem, M.D
Outcome results
None listed