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

February 12, 2024 updated by: Sohaila Essam Mohamed, Assiut University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: doaa gamal, lecteure
  • Phone Number: 01118118806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cisplatin and gemicitabine
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
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
Experimental: capecitabine
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adjuvant treatment in BC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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