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Not yet recruiting NCT06268327

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

Phase II / Phase III Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cisplatin injection and gemcitabine, Capecitabine tablets.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug Cisplatin injection and gemcitabine
    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
  • Drug Capecitabine tablets
    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

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer [Time frame: 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06268327 · Adjuvant treatment in BC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗