AzTrials
AzTrials

Breast Cancer FemaleXenoBreastNCT04133077

Xenografts Development From Surgical Tumor Samples of Patients With Triple Negative or Luminal B Breast Cancer

A study testing blood samples collection in people with Breast Cancer Female, run by Centre Jean Perrin at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Patient derived xenografts (PDX) from mammary tumors are usually made from metastatic tumors. Indeed, PDX from primitive mammary tumors or after neoadjuvant treatment are still rare. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
blood samples collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteFrance
Study dates
19 Nov 2021to 31 Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  • Signature of the participation consent to the study,
  • Affiliation to a social security scheme
  • Major woman with:
  • metastatic triple-negative (TN) breast cancer, histologically proven before treatment and high grade, receiving neoadjuvant chemotherapy and having, after treatment, a breast residue of at least 15 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of neoadjuvant treatment
  • metaplastic triple-negative (TN) breast cancer, histologically proven before treatment and high grade, treated by primary surgery with a tumor size of at least 15 mm on the specimen.
Show all 11Show fewer
  • an inflammatory TN breast cancer (T4d), histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a breast residue of at least 15 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment.
  • non-metaplastic or inflammatory TN breast cancer, histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a mammary residue of at least 30 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment.
  • Luminal B breast cancer (LB), histologically proven prior to treatment, receiving neoadjuvant chemotherapy and having, after treatment, a mammary residue of at least 30 mm on the specimen. The mammary residue will measure at least 15 mm on the mammography performed at the end of the neoadjuvant treatment.
  • histologically proven metastatic TN or metastatic breast cancer with an operable metastasis whose residual size, after chemotherapy, is at least 10 mm on the specimen. Residual metastasis will be at least 15 mm on imaging.
  • Patients in a metastatic situation can be included regardless of the therapeutic line.

Who cannot join

  • Pregnant woman
  • Patient deprived of liberty by court or administrative decision
  • In neoadjuvant situation: no neoadjuvant treatment by radiotherapy or hormone therapy
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Judith PASSILDAS, PhD contact

+33463663337

judith.passildas@clermont.unicancer.fr

France1 site, 1 recruiting

  • Centre Jean PERRIN

    Clermont-Ferrand, Puy-de-Dôme, 63011

    Judith PASSILDAS JAHANMOHAN, PhD, 0473270805, judith.passildas@clermont.unicancer.fr

    Recruiting

Other trials in France

About this study

Official title: A Prospective Study of Xenografts Development From Samples Taken From Surgical Specimens of Patients With Triple Negative or Luminal B Breast Cancer

Patient derived xenografts (PDX) from mammary tumors are usually made from metastatic tumors. Indeed, PDX from primitive mammary tumors or after neoadjuvant treatment are still rare. However, the realization of such PDX (from primitive mammary tumors or after neoadjuvant treatment) would make it possible to have a better knowledge of the tumor heterogeneity to the therapeutic response, to explore the models of tumor evolution during metastatic progression and also observe the mechanisms of tumor resistance in the case of non-metastatic tumors. It therefore seems necessary to develop PDX from primitive tumors in order to observe firstly the success rate of PDX; on the other hand, the drift of the initial heterogeneity, measured by comparison of the histomolecular profile of the tumors with that of the PDXs. It aims to develop xenografts from tumor samples from surgical specimens of patients with triple negative or luminal B breast cancer.

Being tested
blood samples collection
Keywords
PDX

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood samples collectionBiological

    Serology and genetic analyses will be performed in patients blood samples

Study groups in NCT04133077
Study groupRoleWhat they receive
Succeed PDXOtherGenetic analysis will be performed in patients who got a successful PDX
Receives: Biological: blood samples collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of successfull PDX

    PDX will be realized from patient tumor by transplanting a small fragment in a nude mouse. Once the tumor is enough grown up, the tumor is extracted to repeat this step 3 times until we get the fourth PDX with a successful tumor growth.

    Measured: 2 years

Secondary outcomes (7)

  1. Histological subtype

    Comparaison of initial tumor histological subtype with PDX histological subtype

    Measured: 2 years and 4 months

  2. expression of estrogen receptors

    Comparaison of initial tumor expression of estrogen receptors with PDX expression of estrogen receptors

    Measured: 2 years and 4 months

  3. expression of progesterone receptors

    Comparaison of initial tumor expression of progesterone receptors with PDX expression of progesterone receptors

    Measured: 2 years and 4 months

  4. status of the amplification of the ERBB2 gene

    Comparaison of initial tumor's ERBB2 gene amplification status with PDX's ERBB2 gene amplification status

    Measured: 2 years and 4 months

  5. expression of androgen receptors

    Comparaison of initial tumor expression of androgen receptors with PDX expression of androgen receptors

    Measured: 2 years and 4 months

  6. tumor molecular classification

    Comparaison of initial tumor molecular expression with PDX molecular classification (luminal A, luminal B, HER2 enriched or triple negative)

    Measured: 2 years and 4 months

  7. Exome sequencing

    Comparaison of genetic alterations between intial tumor, PDX and blood sample

    Measured: 2 years and 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start19 Nov 2021
  3. Primary completion31 Aug 2030 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
The intervention consists in the realization of additional blood samples to carry out serologies and genetic analyses
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133077
Sponsor's protocol ID
2020-A00398-31
Acronym
XenoBreast
Status last verified
Mar 2026
First submitted
16 Oct 2019
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Veyssiere H, Passildas J, Ginzac A, Lusho S, Bidet Y, Molnar I, Bernadach M, Cavaille M, Radosevic-Robin N, Durando X. XENOBREAST Trial: A prospective study of xenografts establishment from surgical specimens of patients with triple negative or luminal b breast cancer. F1000Res. 2020 Oct 9;9:1219. doi: 10.12688/f1000research.26873.3. eCollection 2020.

    PubMed 34249349

Questions about this trial

What is this clinical trial studying?

A study testing blood samples collection in people with Breast Cancer Female, run by Centre Jean Perrin at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Judith PASSILDAS, PhD (+33463663337, judith.passildas@clermont.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of successfull PDX (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133077, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in