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Not yet recruiting NCT07687446

Performance of Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early Triple-Negative Breast Cancer

Observational Breast Cancer (Triple Negative Breast Cancer (TNBC))

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: Non interventional study.
Who it may be relevant to
Registry conditions: Breast Cancer (Triple Negative Breast Cancer (TNBC)). Basic parameters: from 18 years · Female.
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 →

Overview

The goal of this observational, retrospective, non interventional study is to learn about the efficacy of an Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early Triple-Negative Breast Cancer (TNBC). The main question it aims to answer is : \- What is the efficacy of this kind of treatment, by evaluating the pathological complete response (PCR), that is to say, the percentage of patients where no tumor cells remained when they underwent surgery after neoadjuvant treatment. The other points that will be evaluated are: * The treatment regimen * The epidemiological characteristics of the treated population * The efficacy by relapse-free survival ; overall survival * The tolerability and adverse effects The standard treatment for localized TNBC (larger than 2 cm or with lymph node involvement) is neoadjuvant chemoimmunotherapy, which includes anthracyclines. However, in real-world practice, some patients have a contrindication to this treatment because they have received it previously, are too old, or have comorbidities, particularly cardiovascular disease. Currently, there is limited data on the modalities and efficacy of such treatment.

Interventions

  • Other Non interventional study
    Non interventional Study

Primary outcome measures

  • Pathological Complete Response (PCR) [Time frame: At Surgery]
Secondary outcome measures (3)
  • Adverse Effects [Time frame: 6-48 months according to treatment start]
  • Epidemiologic description of the population treated [Time frame: Baseline]
  • Type of treatment anthracycline-free [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Patients over 18 years of age
  • Patients being treated for localized triple-negative breast cancer, who received neoadjuvant chemotherapy with immunotherapy, without anthracycline
  • Patients who have undergone surgery, with an available pathology report.

Exclusion criteria

  • Patient refusal to allow data use
  • Patient who has not undergone surgery
  • Metastatic patients
  • Patients who have received at least one anthracycline-based treatment cycle

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07687446 · APHP260635

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗