CClinicalTrials.gg
Not yet recruitingNCT07687446NEO-AgeTNUpdated Jul 7, 2026

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

An observational study in Breast Cancer (Triple Negative Breast Cancer (TNBC)), sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 100 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

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

    Other: Non interventional study

Interventions

  • OtherNon interventional study

    Non interventional Study

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07687446
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jul 7, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Jul 7, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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