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

Assiut University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Capecitabine tablets; Drug: Cisplatin injection and gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT06268327

Adjuvant treatment in BC

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

cisplatin and gemicitabine

Experimental group

Description:

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

Treatment:

Drug: Cisplatin injection and gemcitabine

capecitabine

Experimental group

Description:

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

Treatment:

Drug: Capecitabine tablets