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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07687446
Acronym
NEO-AgeTN
Enrollment
100
Registered
2026-07-07
Start date
2026-11-01
Completion date
2027-05-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer (Triple Negative Breast Cancer (TNBC))

Brief summary

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

OTHERNon interventional study

Non interventional Study

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pathological Complete Response (PCR)At Surgery

Secondary

MeasureTime frame
Adverse Effects6-48 months according to treatment start
Epidemiologic description of the population treatedBaseline
Type of treatment anthracycline-freeBaseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026