Performance of Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early Triple-Negative Breast Cancer (NEO-AgeTN)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with early TNBC treated with an Anthracycline-Free Neoadjuvant Chemoimmunotherapy
|
Non interventional Study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pathological Complete Response (PCR)
Time Frame: At Surgery
|
At Surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adverse Effects
Time Frame: 6-48 months according to treatment start
|
6-48 months according to treatment start
|
|
Epidemiologic description of the population treated
Time Frame: Baseline
|
Baseline
|
|
Type of treatment anthracycline-free
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP260635
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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