Triple -Negative Breast Cancer
Conditions
Keywords
early stage breast cancer triple negative
Brief summary
Eligible patients was assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy.
Detailed description
Eligible patients will randomly open label assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy. The capecitabine maintenance group will receive oral capecitabine at 650 mg/m2, twice daily continuously for 1 year. Total follow up of the study is 2 years, one year for drug receving with monthy follow up for adverse effect and the other year for every 3 months follow up to asses DFS and OS. Collection of capecitabine dose will receive and adverse events will assessed monthly during capecitabine maintenance in the capecitabine group. In both groups, physical examination, assessment of menopausal status, breast ultrasound, and abdominal ultrasound were performed every 3 months during 2 years of follow up; mammography and chest x-ray were performed yearly. Patients who has not experienced recurrence or death at the time of data analysis will censored as alive and event-free at the date of last follow-up.
Interventions
DRUGcapecitabine
capecitabine 650 mg / m2 twice per day for one year
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible trial participants will women who has pathologically confirmed invasive breast ductal carcinoma Hormone receptor negative (\<1% positive cells by immunohistochemistry staining) and ERBB2 negative. Participants had early-stage tumors that were stage T1b-3N0-3cM0, without positive supraclavicular or internal mammary lymph node. They received standard treatments, including modified radical mastectomy or breast-conserving surgery, neo-/adjuvant chemotherapy, and radiotherapy according to institutional guidelines. * patients were able to swallow tablets * performance status 0 - 1
Exclusion criteria
* Key
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse effents of capictabine | assess the adverse effects of the Capecitabine 6 months after starting treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| distant disease-free survival | up to 24 months from diagnosis | defined as the time from randomization to the first occurrence of the following events: local relapse, distant metastasis or contralateral breast cancer. |
| overall survival | 24 months from diagnosis | the time from randomization to death from any cause |
Countries
Egypt
Outcome results
None listed