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Breast CancerBREAST IMMUNNCT01440413

Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer

A study testing Blood and tumor sample in people with Breast Cancer, run by Centre Leon Berard at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, non-randomized study which aims to evaluate the response to a neoadjuvant chemotherapy according to the the antitumor immune response in localized breast cancer. 40 patients will be enrolled in the study. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Blood and tumor sample
Type of treatment
Injection or infusion
How many people
40 participants
Where
2 sitesFrance
Study dates
Dec 2011to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

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

  • Histologically proven localized breast cancer required anthracycline chemotherapy +/- trastuzumab before surgery
  • Age > 18 years
  • Chemotherapy with 3 anthracycline cycles to begin (doxorubicin or epirubicin)
  • Any previous treatment for this cancer
  • Performance Status <= 1
  • Agreement for the conservation of biological samples
Show all 9Show fewer
  • Covered by an medical insurance
  • Signed written informed consent form
  • Availability of tumoral sample collected at diagnosis

Who cannot join

  • Previous surgery for the breast cancer
  • Already under chemotherapy before the first blood sample
  • Previous Antitumoral treatment
  • Under immunosuppressive treatment
  • Under corticoids during the 15 days before enrollment
  • History of concomitant cancer except if it has been cured for at least 5 years
Show all 11Show fewer
  • History of lymphoma or breast sarcoma
  • History of chronic inflammatory disease or autoimmune disease, hepatitis B or C or immune dysfunction disease (including HIV-positive stage AIDS) known
  • History of other disease which is discrepant with this study
  • Deprived of liberty by court or administrative decision
  • Pregnant or breastfeeding women or with no use of effective birth control methods for women of childbearing potential

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Leon Berard

    Lyon, 69373

Other trials in France

About this study

This is a prospective, non-randomized study which aims to evaluate the response to a neoadjuvant chemotherapy according to the the antitumor immune response in localized breast cancer.

40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4 anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles.

Read more

Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated and receive an adjuvant treatment which will both depend on the investigator's appreciation.

Blood sample will be collected on the first day of the first chemotherapy cycle, on the first day of the third cycle, on surgery, 6 months after the surgery and in case of relapse.

Tumor sample will be collected on diagnosis as much as possible and on surgery.

Patients will be followed during 5 years.

Conditions
Breast Cancer
Being tested
Blood and tumor sample
Keywords
anti-tumor immune response, neo-adjuvant chemotherapy, relapse, long term survival, histo-pathological response, tumor cell death, tumor associated antigens, Calreticulin, Localized breast cancer
Medical subject headings
Breast Neoplasms, Recurrence

What participants receive

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

  • Blood and tumor sampleBiological

    Blood samples will be collected on the first day of the first cycle of chemotherapy (before injection of chemotherapy), on the first day of the third cycle (before injection of chemotherapy), on day of surgery and 6 months after surgery and in case of relapse.

    Tumor samples will be collected on diagnosis, on surgery and on the first day of the third chemotherapy course (optional).

What is being measured

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

  1. Determine the correlation between histopathological response (pCR) and induction of tumor immunity in response to neoadjuvant chemotherapy

    Rate of histopathologic response (IHC). Analysis of lymphocyte subpopulations (whole blood - flow cytometry). Analysis of the frequency of immune cells, the phenotype and functional status on the site of the tumor (fixed tissue - IHC). Analysis of the functional status of sub-populations of DC and lymphocytes of innate immunity (fresh whole blood - flow cytometry). Analysis of BCR and TCR repertoires (mononuclear cells - PCR). Identification of TAA expressed by the tumor (plasma, tumor - ELISA, IHC).Analysis of the humoral response against TAA (plasma - ELISA).

    Measured: Day (D) 1 chemotherapy (CT) n°1, D1 CT n°3, Surgery, 6 month post surgery

Secondary outcomes (4)

  1. Evolution of the immune profile during management of localized breast cancer

    Analysis in plasma of the rate of apoptotic tumor cells, of TAA (CEA and MUC1 ELISA), of tumor DNA and endogenous ligands of TLR (HMGB1 ELISA) Assay of cytokines and chemokines in plasma Analysis of the expression of proteins involved in the translocation of CRT to the cell surface (fixed-frozen tissue - IHC or immunoblotting) Analysis on the tumor (IHC or immunoblotting) of degradation of BAP31, activation of caspase 8/Bax/Bak, phosphorylation of eIF2 and exposure of surface CRT, KDEL receptor and ERp57

    Measured: D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery

  2. Analysis of genetic polymorphisms

    Analysis of P2X7 and TLR4 polymorphisms on circulating cells (plasma)

    Measured: D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery

  3. Determination of relapse risk based on biological characteristics identified

    Progression-free survival

    Measured: At the end of the study (5 years of follow-up)

  4. Determining the risk of death based on biological characteristics identified

    Overall survival

    Measured: At the end of the study (5 years of follow-up)

Timeline

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

  1. First posted26 Sep 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionDec 2018
  4. Study completionDec 2020 (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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01440413
Sponsor's protocol ID
BREAST IMMUN
Other IDs
ET11-059
Acronym
BREAST IMMUN
Status last verified
Mar 2020
First submitted
14 Sep 2011
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Apetoh L, Ghiringhelli F, Tesniere A, Obeid M, Ortiz C, Criollo A, Mignot G, Maiuri MC, Ullrich E, Saulnier P, Yang H, Amigorena S, Ryffel B, Barrat FJ, Saftig P, Levi F, Lidereau R, Nogues C, Mira JP, Chompret A, Joulin V, Clavel-Chapelon F, Bourhis J, Andre F, Delaloge S, Tursz T, Kroemer G, Zitvogel L. Toll-like receptor 4-dependent contribution of the immune system to anticancer chemotherapy and radiotherapy. Nat Med. 2007 Sep;13(9):1050-9. doi: 10.1038/nm1622. Epub 2007 Aug 19.

    PubMed 17704786

  • Banchereau J, Briere F, Caux C, Davoust J, Lebecque S, Liu YJ, Pulendran B, Palucka K. Immunobiology of dendritic cells. Annu Rev Immunol. 2000;18:767-811. doi: 10.1146/annurev.immunol.18.1.767.

    PubMed 10837075

  • Bates GJ, Fox SB, Han C, Leek RD, Garcia JF, Harris AL, Banham AH. Quantification of regulatory T cells enables the identification of high-risk breast cancer patients and those at risk of late relapse. J Clin Oncol. 2006 Dec 1;24(34):5373-80. doi: 10.1200/JCO.2006.05.9584.

    PubMed 17135638

  • Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. doi: 10.1200/JCO.2005.04.1665. Epub 2006 Apr 10.

    PubMed 16606972

  • Blay JY, Chauvin F, Le Cesne A, Anglaret B, Bouhour D, Lasset C, Freyer G, Philip T, Biron P. Early lymphopenia after cytotoxic chemotherapy as a risk factor for febrile neutropenia. J Clin Oncol. 1996 Feb;14(2):636-43. doi: 10.1200/JCO.1996.14.2.636.

    PubMed 8636781

  • Borg C, Ray-Coquard I, Philip I, Clapisson G, Bendriss-Vermare N, Menetrier-Caux C, Sebban C, Biron P, Blay JY. CD4 lymphopenia as a risk factor for febrile neutropenia and early death after cytotoxic chemotherapy in adult patients with cancer. Cancer. 2004 Dec 1;101(11):2675-80. doi: 10.1002/cncr.20688.

    PubMed 15503313

  • Chapman C, Murray A, Chakrabarti J, Thorpe A, Woolston C, Sahin U, Barnes A, Robertson J. Autoantibodies in breast cancer: their use as an aid to early diagnosis. Ann Oncol. 2007 May;18(5):868-73. doi: 10.1093/annonc/mdm007. Epub 2007 Mar 7.

    PubMed 17347129

  • Disis ML, Knutson KL, Schiffman K, Rinn K, McNeel DG. Pre-existent immunity to the HER-2/neu oncogenic protein in patients with HER-2/neu overexpressing breast and ovarian cancer. Breast Cancer Res Treat. 2000 Aug;62(3):245-52. doi: 10.1023/a:1006438507898.

    PubMed 11072789

  • Domschke C, Schuetz F, Ge Y, Seibel T, Falk C, Brors B, Vlodavsky I, Sommerfeldt N, Sinn HP, Kuhnle MC, Schneeweiss A, Scharf A, Sohn C, Schirrmacher V, Moldenhauer G, Momburg F, Beckhove P. Intratumoral cytokines and tumor cell biology determine spontaneous breast cancer-specific immune responses and their correlation to prognosis. Cancer Res. 2009 Nov 1;69(21):8420-8. doi: 10.1158/0008-5472.CAN-09-1627. Epub 2009 Oct 20.

    PubMed 19843863

  • Fan C, Oh DS, Wessels L, Weigelt B, Nuyten DS, Nobel AB, van't Veer LJ, Perou CM. Concordance among gene-expression-based predictors for breast cancer. N Engl J Med. 2006 Aug 10;355(6):560-9. doi: 10.1056/NEJMoa052933.

    PubMed 16899776

  • Guckel B, Rentzsch C, Nastke MD, Marme A, Gruber I, Stevanovic S, Kayser S, Wallwiener D. Pre-existing T-cell immunity against mucin-1 in breast cancer patients and healthy volunteers. J Cancer Res Clin Oncol. 2006 Apr;132(4):265-74. doi: 10.1007/s00432-005-0064-6. Epub 2005 Dec 22.

    PubMed 16374613

  • Loprinzi CL, Thome SD. Understanding the utility of adjuvant systemic therapy for primary breast cancer. J Clin Oncol. 2001 Feb 15;19(4):972-9. doi: 10.1200/JCO.2001.19.4.972.

    PubMed 11181659

  • Ray-Coquard I, Ghesquiere H, Bachelot T, Borg C, Biron P, Sebban C, LeCesne A, Chauvin F, Blay JY; ELYPSE Study Group. Identification of patients at risk for early death after conventional chemotherapy in solid tumours and lymphomas. Br J Cancer. 2001 Sep 14;85(6):816-22. doi: 10.1054/bjoc.2001.2011.

    PubMed 11556830

  • Remontet L, Esteve J, Bouvier AM, Grosclaude P, Launoy G, Menegoz F, Exbrayat C, Tretare B, Carli PM, Guizard AV, Troussard X, Bercelli P, Colonna M, Halna JM, Hedelin G, Mace-Lesec'h J, Peng J, Buemi A, Velten M, Jougla E, Arveux P, Le Bodic L, Michel E, Sauvage M, Schvartz C, Faivre J. Cancer incidence and mortality in France over the period 1978-2000. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):3-30.

    PubMed 12684578

  • Rentzsch C, Kayser S, Stumm S, Watermann I, Walter S, Stevanovic S, Wallwiener D, Guckel B. Evaluation of pre-existent immunity in patients with primary breast cancer: molecular and cellular assays to quantify antigen-specific T lymphocytes in peripheral blood mononuclear cells. Clin Cancer Res. 2003 Oct 1;9(12):4376-86.

    PubMed 14555509

Questions about this trial

What is this clinical trial studying?

A study testing Blood and tumor sample in people with Breast Cancer, run by Centre Leon Berard at 2 sites 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the correlation between histopathological response (pCR) and induction of tumor immunity in response to neoadjuvant chemotherapy (time frame: Day (D) 1 chemotherapy (CT) n°1, D1 CT n°3, Surgery, 6 month post surgery). 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 NCT01440413, which also lists 24 linked publications.

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 24 Mar 2020.

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