Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06268327

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

    Time frame: 2 years

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

Secondary outcomes

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

doaa gamal, lecteure

CONTACT

01118118806

samy Ali, professor

CONTACT

[email protected]

01029639637

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.