Breast Cancer
Conditions
Brief summary
In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine
Detailed description
Patients with operable, primary invasive non inflammatory early TNBC of stage I-IIIB and pathologically verified residual cancer cells (no pathological complete response) after neoadjuvant chemotherapy then underwent adjuvant treatment with gemcitabine plus cisplatin Patients will be followed up every 3 month in first year then every 6 month in the second year then followed up yearly Study will be conducted at Assiut University Hospital with sample size calculation BRACA will be done
Interventions
DRUGCisplatin injection and gemcitabine
Patients with operable, primary invasive noninflammatory early TNBC of stage I-IIIB and pathologically verified residual cancer cells (no pathological complete response) after neoadjuvant chemotherapy then underwent adjuvant treatment with gemcitabine plus cisplatin Pt will be followed up every 3 month in first year then every 6 month in the second year then followed up yearly Study will be conducted at Assiut University Hospital with sample size calculation BRACA will be done
DRUGCapecitabine tablets
Patients with operable, primary invasive noninflammatory early TNBC of stage I-IIIB and pathologically verified residual cancer cells (no pathological complete response) after neoadjuvant chemotherapy then underwent adjuvant treatment with capecitabine Pt will be followed up every 3 month in first year then every 6 month in the second year then followed up yearly Study will be conducted at Assiut University Hospital with sample size calculation BRACA will be done
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age: 20 years and older. * Patients with no clinical/radiologic distant metastasis. * Tumor type: Invasive ductal carcinoma or invaive lobular carcinoma. * Tumor subtype: triple negative * patients had operable, primary invasive, noninflammatory early stage I-IIIB TNBC (ER and PR \<1%, HER2 score: 0 or 1) * Patients with a good performance status (0/1) * Patients with adequate hematological, cardiac, renal, and hepatic function
Exclusion criteria
* Patients who achieve pathologic complete response after neoadjuvant chemotherapy * inflammatory breast cancer * Breast cancer patients with distant metastasis * Patient with hormonal receptor positive /HER2 +ve
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy | 2 years | 2 years disease free survival which is calculated since time of surgery till occurance of local or distant recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer | 3 years | Compare if the investigated regimen is superior or same as standard regimen and the investigators will notice and document toxicity of both regimens including gastrointestinal toxicity, neurological toxicity, hematologic toxicity renal toxicity, ototoxicity and skin toxicity according to CTCAE version 4.1 also over all survival will be measured which is calculated from time of diagnosis till death or finishing our study minimum 3 years |
Contacts
Primary Contactsamy Ali, professor
Backup Contactdoaa gamal, lecteure
Outcome results
None listed