Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

May 24, 2023 updated by: Mohammad Jahan Shams, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
In this study, individuals with triple-negative breast cancer will receive either a platinum-based or non-platinum-based preoperative chemotherapy treatment. This study will help us identify which option is the most effective and safe.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is a significant health concern, and triple-negative breast cancer (TNBC) is a particularly aggressive and lethal subtype. Chemotherapy is currently the only recommended systemic treatment for TNBC, with the standard regimen being a combination of anthracyclines and taxanes. Platinum agents have shown promising results in TNBC neoadjuvant chemotherapy due to their ability to damage DNA and be more effective in tumors with dysfunctional DNA repair mechanisms. However, there is still a lack of consensus on the optimal neoadjuvant chemotherapy regimen for TNBC. This study will be conducted to compare the responses and toxicities of platinum-based versus non-platinum-based neoadjuvant chemotherapy in TNBC patients receiving neoadjuvant chemotherapy in the Department of Clinical Oncology of Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbagh, Dhaka. After pretreatment evaluation, a total of 82 patients who fulfill the inclusion and exclusion criteria will be divided into Arm A and Arm B by simple random sampling. After the completion of the chemotherapy, all patients will undergo surgical management. A postoperative histopathology report will be collected and assessed by the investigator. During the treatment, the patients will be monitored before each cycle of chemotherapy, including physical examinations and laboratory investigations. All the relevant data will be compiled on a master chart first, and then statistical analysis of the results will be obtained by using Windows-based computer software facilities with Statistical Packages for Social Sciences. The data will be analyzed using the Chi-square test and the "T' test. The results will be presented in tables, figures, and diagrams. A significant value of 'p' will be decided at a level of 0.05 in two-tailed tests.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 2

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

  • Name: Mohammad J Shams, MBBS, MD
  • Phone Number: +8801911177774
  • Email: jsnitol@gmail.com

Study Contact Backup

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Bangabandhu Sheikh Mujib Medical University
        • Contact:
        • Principal Investigator:
          • Mohammad J Shams, MBBS, MD
        • Sub-Investigator:
          • Sajib K Talukdhar, MBBS, MD

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

No

Description

Inclusion Criteria:

  • Triple-negative breast cancer
  • Stage II and III

Exclusion Criteria:

  • Double primaries
  • Male breast cancer
  • Pregnant or lactating women
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status more than two
  • Patients below 18 years old
  • Initial surgery of the primary site (excluding diagnostic biopsy)
  • Serious concomitant medical illness including clinically significant cardiovascular disease
  • Major surgery or trauma in the previous four weeks

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platinum-based regimen
Patients will be treated with doxorubicin 60 mg/m2 IV on day 1 and cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 IV weekly for 12 weeks concurrently with carboplatin (area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles).
Drug: Doxorubicin
60 mg/m2 IV bolus on day 1 every three weeks for four cycles.
Other Names:
  • Adriamycin
Drug: Cyclophosphamide
600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.
Other Names:
  • Cytoxan
Drug: Paclitaxel
80 mg/m2 IV over 1 hour weekly for 12 weeks
Other Names:
  • Taxol
Drug: Carboplatin
Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles
Other Names:
  • Paraplatin
Active Comparator: Non-platinum based regimen
Patients will be treated with doxorubicin 60 mg/m2 IV on day 1 and cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 IV weekly for 12 weeks.
Drug: Doxorubicin
60 mg/m2 IV bolus on day 1 every three weeks for four cycles.
Other Names:
  • Adriamycin
Drug: Cyclophosphamide
600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.
Other Names:
  • Cytoxan
Drug: Paclitaxel
80 mg/m2 IV over 1 hour weekly for 12 weeks
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response rate
Time Frame: 1 year
Pathological complete response: Post-operative pathology revealed no residual invasive cancer in the breast or lymph nodes.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: 1 year
Clinical response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which rely on a history, clinical exam, and imaging.
1 year
Treatment related acute toxicity
Time Frame: 1 year
The American National Cancer Institute's "Common Terminology Criteria for Adverse Events" will be utilized to assess toxicity.
1 year

Collaborators and Investigators

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

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Principal Investigator: Mohammad J Shams, MBBS, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

May 14, 2023

First Submitted That Met QC Criteria

May 14, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU/2023/6669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Triple Negative Breast Cancer

Clinical Trials on Doxorubicin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe