Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy
Overview
- Phase
- Phase 2
- Intervention
- Cisplatin injection and gemcitabine
- Conditions
- Breast Cancer
- Sponsor
- Assiut University
- Enrollment
- 30
- Primary Endpoint
- Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Sohaila Essam Mohamed
Assiut university Hospital
Assiut University
Eligibility Criteria
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
Arms & Interventions
cisplatin and gemicitabine
patients with triple negative breast cancer will recieve adjuvant cisplatin and gemicitabine in non pathological complete response after neo-adjuvant standard chemotherapy with dose of cisplatin 70mg/m2 at day one and gemicitabine 1000mg/m2 day one and day eight every 21 day for six cycle
Intervention: Cisplatin injection and gemcitabine
capecitabine
patients with triple negative breast cancer will recieve adjuvant capecitabin in non pathological complete response after neo-adjuvant standard chemotherapy with dose of capecitabine 1000-1250 mg/m2 every 21 day for six cycle
Intervention: Capecitabine tablets
Outcomes
Primary Outcomes
Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy
Time Frame: 2 years
2 years disease free survival which is calculated since time of surgery till occurance of local or distant recurrence
Secondary Outcomes
- Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer(3 years)