Biopsy (optional) / Triple Negative Breast Neoplasm / Biopsy · Interventional Study

Tracking Triple-negative Breast Cancer Evolution Through Therapy

ClinicalTrials.gov · August 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is an active prospective multicentre study investigating the relationship between intratumour heterogeneity and pathological complete response in triple-negative breast cancer patients undergoing neoadjuvant chemotherapy. The registry record documents planned enrollment and primary outcome but contains no efficacy or safety results.

What was studied

Interventional, Single Group, Open label, Diagnostic purpose. Triple-Negative Breast Neoplasm; age from 18 Years. Intervention: All included patients. n = 149. 10 sites: France.

Key findings

Safety

This is a registry record only; no efficacy, safety, or outcome results are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active clinical trial registry record with no reported results; enrollment is complete but outcome data are not yet published in this registry entry.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Rate of pathological complete response (pCR) (assessed at pCR will be defined at the time of surgery on the tumor specimen)

DesignInterventional, Single Group, Open label, Diagnostic purpose

PopulationTriple-Negative Breast Neoplasm; age from 18 Years

Sample size149

InterventionAll included patients

Setting10 sites: France

Reported figures

Quoted from the source exactly as published.

Planned enrollment149

Primary outcome measureRate of pathological complete response (pCR), defined at time of surgery on the tumor specimen

Caveats

This is a registry record only; no efficacy, safety, or outcome results are reported.
Study phase is listed as 'NA'; regulatory phase classification is unclear from this record.
No information on primary outcome results, effect sizes, or comparators is available.
Blinding, randomization, and risk-of-bias mitigation strategies are not described in this registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective multicentre interventional design with biopsy procedures specified.

Directness

strong

Directly examines intratumour heterogeneity and pathological response to neoadjuvant chemotherapy.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or other bias mitigation.

Sample adequacy

moderate

149 participants enrolled; sample size appears adequate but justification not stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT03077776). This is a study registration, not published results. Lead sponsor: UNICANCER. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 149 participants (ACTUAL). Conditions: Triple-Negative Breast Neoplasm. Interventions: PROCEDURE: Biopsy; PROCEDURE: Biopsy (optional); PROCEDURE: Biopsy (metastatic). Primary outcome measures: Rate of pathological complete response (pCR) , pCR will be defined at the time of surgery on the tumor specimen. Brief summary: A prospective multicentre study which aims to examine the relationship between intratumour heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with histological confirmation of triple-negative breast cancer (TNBC) who are eligible for neoadjuvant chemotherapy.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Biopsy (optional)NCT03077776Triple Negative Breast NeoplasmUNICANCERBiopsyBiopsy (metastatic)