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NCT Number: NCT07687446

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

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.

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Key information

Conditions

Breast Cancer (Triple Negative Breast Cancer (TNBC)) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non interventional study

Other

Non interventional Study

Primary outcomes

  1. Pathological Complete Response (PCR)

    Time frame: At Surgery

Secondary outcomes

  1. Adverse Effects

    Time frame: 6-48 months according to treatment start

  2. Epidemiologic description of the population treated

    Time frame: Baseline

  3. Type of treatment anthracycline-free

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: NEO-AgeTN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

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.

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