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Trial Title:
Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy
NCT ID:
NCT06268327
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Gemcitabine
Capecitabine
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cisplatin injection and gemcitabine
Description:
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
Arm group label:
cisplatin and gemicitabine
Intervention type:
Drug
Intervention name:
Capecitabine tablets
Description:
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
Arm group label:
capecitabine
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
April 30, 2024
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06268327
