NCT06965361

Brief Summary

The goal of this observational study is to learn about the effects of neoadjuvant chemotherapy (NACT) anthracycline-containing, taxane- (Intervention A +T) and anthracycline/taxane /carboplatin (Intervention A+T+C) treatment in young (age; 24-45 years) Triple Negative Breast Cancer (TNBC) female Patients by evaluating Stromal tumor-infiltrating lymphocytes (TILs) Programmed cell death-1 (PD-1), its ligand (PD-L1) and lymphocyte activation gene-3 (LAG-3) checkpoint proteins within tumor. The main question it aims to answer is: Does TILs are the most reliable immune markers and are significantly associated with PD-1, PD-L1 and LAG-3 in carboplatin based NACT treated (Intervention A+T+C) group of TNBC patients? Participants (TNBC Patients) already taking intervention A+T and A+T+C as part of their regular medical care for TNBC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

April 23, 2025

Last Update Submit

May 12, 2025

Conditions

Triple Negative Breast Cancer

Keywords

carboplatin-based NACT regimentumor-infiltrating lymphocytesProgrammed cell death-1Programmed cell death Ligand-1lymphocyte activation gene-3Triple-negative breast cancer

Outcome Measures

Primary Outcomes (1)

  • Stromal tumor-infiltrating lymphocyte levels are associated with immune checkpoint proteins in triple negative breast cancer patients receiving neoadjuvant chemotherapy

    The TILs levels were evaluated on Hematoxylin-eosin-stained (H\&E) tissue sections as percentages and three predefined categories were used: Low TIL scores of 0-10%, intermediate 11-40% and high TIL \> 40%.

    From enrollment to the end of treatment received at least four cycles of NACT regimens. One cycle last for 21 days.

Secondary Outcomes (1)

  • Evaluation of PD-1, PD-L1 and LAG-3 in triple negative breast cancer patients receiving neoadjuvant chemotherapy

    From enrollment to the end of treatment received at least four cycles of NACT regimens. One cycle last for 21 days.

Study Arms (1)

A+T group and A+T+C group

All TNBC patients included in the study received at least four cycles of NACT regimens and were classified into two groups: anthracycline-containing, taxane- (A+T group) and anthracycline/taxane/carboplatin (A+T+C group) combinations

Drug: carboplatinDevice: carboplatin

Interventions

carboplatinDRUG

carboplatin use due to its effectiveness in increasing pathological complete remission (pCR) rates and improving survival outcomes

Also known as: Doxorubicin
A+T group and A+T+C group

Eligibility Criteria

Age24 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with diagnosed TNBC (Age;24-45 years)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Karachi subset of population

You may qualify if:

  • Female (aged 24-45 years) TNBC patients
  • Diagnosed TNBC Patients with immunohistochemistry (IHC) negative test for estrogen receptor (ER), progesterone receptor (PR), and HER-2
  • Patients with and without metastases

You may not qualify if:

  • Patients who had a history of other malignant tumors
  • Patients who did not complete NAC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shamim

Karachi, Sindh, 75270, Pakistan

Location

Related Publications (1)

  • Loibl S, Weber KE, Timms KM, Elkin EP, Hahnen E, Fasching PA, Lederer B, Denkert C, Schneeweiss A, Braun S, Salat CT, Rezai M, Blohmer JU, Zahm DM, Jackisch C, Gerber B, Klare P, Kummel S, Schem C, Paepke S, Schmutzler R, Rhiem K, Penn S, Reid J, Nekljudova V, Hartman AR, von Minckwitz G, Untch M. Survival analysis of carboplatin added to an anthracycline/taxane-based neoadjuvant chemotherapy and HRD score as predictor of response-final results from GeparSixto. Ann Oncol. 2018 Dec 1;29(12):2341-2347. doi: 10.1093/annonc/mdy460.

    PMID: 30335131BACKGROUND

Related Links

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

CarboplatinDoxorubicin

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Shamim Mushtaq, PhD

    Ziauddin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2025

First Posted

May 11, 2025

Study Start

January 2, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations

PA(1)