Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy

Phase 2

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Capecitabine tablets; Drug: Cisplatin injection and gemcitabine

• Registration Number: NCT06268327
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2023-11-19
• Status Verified: 2024-01
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Study Start: 2024-04-30
• Primary Completion: 2025-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
capecitabine	Capecitabine tablets	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
cisplatin and gemicitabine	Cisplatin injection and gemcitabine	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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