ClinicalTrials.gg
RecruitingNCT04133077XenoBreastUpdated Mar 19, 2026

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

An interventional study of blood samples collection in Breast Cancer Female, sponsored by Centre Jean Perrin. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Centre Jean Perrin · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Nov 2021; still recruiting 4 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Breast Neoplasms by Centre Jean Perrin — 2 open to participants now, 3 under way, none of them phase 3. Breast Neoplasms · Centre Jean Perrin.

Planned enrollment
4th of 21
85 · median 36
Started
2021
with 2 others
No phase
13 of 24
2 open now
Registered
19th of 24
by date

Among the 24 studies in Breast Neoplasms by Centre Jean Perrin, this one is the 4th largest by planned enrollment of the 21 interventional ones that give a count, is one of 3 that started in 2021, is one of 13 with no phase, and was the 19th registered.

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

2 of the 24 studies in Breast Neoplasms by Centre Jean Perrin are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Breast Neoplasms by Centre Jean Perrin, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Breast Cancer Female

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Keywords

  • PDX
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (Eastern Cooperative Oncology Group) performance status ≤ 2
  • Signature of the participation consent to the study,
  • Affiliation to a social security scheme
  • Major woman with:

    • triple-negative (TN) breast cancer, proven before treatment and high grade, receiving 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.
    • 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.

Exclusion criteria

Exclusion Criteria:

  • Pregnant woman
  • Patient deprived of liberty by court or administrative decision
  • In situation: no neoadjuvant treatment by radiotherapy or hormone therapy
  • Refusal to participate in the study
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (estimated)

Study arms

  • Other
    Succeed PDX

    Genetic analysis will be performed in patients who got a successful PDX

    Biological: blood samples collection

Interventions

  • Biologicalblood samples collection

    Serology and genetic analyses will be performed in patients blood samples

06

What researchers measure

Primary outcomes

  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.

    Time frame: 2 years

Secondary outcomes

  1. Histological subtype

    Comparaison of initial tumor histological subtype with PDX histological subtype

    Time frame: 2 years and 4 months

  2. expression of estrogen receptors

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

    Time frame: 2 years and 4 months

  3. expression of progesterone receptors

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

    Time frame: 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

    Time frame: 2 years and 4 months

  5. expression of androgen receptors

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

    Time frame: 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)

    Time frame: 2 years and 4 months

  7. Exome sequencing

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

    Time frame: 2 years and 4 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2021 (actual). Primary completion is estimated for Aug 2030, 105 months after the start.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 105 months is above that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2019
First posted
Oct 21, 2019
StartActual
Nov 19, 2021
Primary completionEst.
Aug 31, 2030
CompletionEst.
Aug 31, 2030
Last update
Mar 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04133077
Lead sponsor
Centre Jean Perrin
Responsible party
Sponsor
First posted
Oct 21, 2019
Start date
Nov 19, 2021
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
Mar 19, 2026

Study contacts

Judith PASSILDAS, PhD
Contact
judith.passildas@clermont.unicancer.fr
+33463663337
Xavier DURANDO, Professor
principal investigator · Centre Jean Perrin

Oversight

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

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