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

NCT07687446 | Not Yet Recruiting

• 1 other identifier: APHP260635
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer (Triple Negative Breast Cancer (TNBC))

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (PCR)

  At Surgery

Secondary Outcomes (3)

• Adverse Effects

  6-48 months according to treatment start

• Epidemiologic description of the population treated

  Baseline

• Type of treatment anthracycline-free

  Baseline

Study Arms (1)

Patients with early TNBC treated with an Anthracycline-Free Neoadjuvant Chemoimmunotherapy

Other: Non interventional study

Interventions

Non interventional study OTHER

Non interventional Study

Patients with early TNBC treated with an Anthracycline-Free Neoadjuvant Chemoimmunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early Triple-Negative Breast Cancer treated with an anthracycline-Free Neoadjuvant Chemoimmunotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07