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

NCT06268327 | Not Yet Recruiting Phase 2

• 1 other identifier: Adjuvant treatment in BC
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy

  2 years disease free survival which is calculated since time of surgery till occurance of local or distant recurrence

  2 years

Secondary Outcomes (1)

• Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer

  3 years

Study Arms (2)

cisplatin and gemicitabine

EXPERIMENTAL

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

Drug: Cisplatin injection and gemcitabine

capecitabine

EXPERIMENTAL

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

Drug: Capecitabine tablets

Interventions

Cisplatin injection and gemcitabine DRUG

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

cisplatin and gemicitabine

Capecitabine tablets DRUG

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

capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cisplatin; Gemcitabine; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

samy Ali, professor

CONTACT

01029639637; samyalgiz@yahoo.com

doaa gamal, lecteure

CONTACT

01118118806

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut university Hospital

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: February 20, 2024
• Study Start: April 30, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-01