AzTrials
AzTrials

Breast CancerNCT04033965

Corellation of Mutations, TILs and Age in Breast Cancer

An observational study of Breast Cancer, run by Hellenic Cooperative Oncology Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Age may pertain to different tumor genotype characteristics which may interfere with treatment efficacy and prognosis. The investigators investigated the distribution and prognostic effect of mutations (mut) and tumor infiltrating lymphocyte (TILs) in young and elderly early breast cancer patients (pts). 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?
Corellation of Mutations, TILs and Age in Breast Cancer
How many people
345 participants
Where
No sites listed yet
Study dates
3 Sep 1997to 1 Oct 2010
Phase
Observational
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

Study population: women with early breast cancer <35 years old or >65 years old

Who may be able to join

  • women with early breast cancer <35 years old or >65 years old

Who cannot join

  • NA

About this study

Official title: Tumor Mutational Patterns and Infiltrating Lymphocyte Density in Young and Old Patients With Breast Cancer

Age may pertain to different tumor genotype characteristics which may interfere with treatment efficacy and prognosis. The investigators investigated the distribution and prognostic effect of mutations (mut) and tumor infiltrating lymphocyte (TILs) in young and elderly early breast cancer patients (pts).

Conditions
Breast Cancer
Being tested
Corellation of Mutations, TILs and Age in Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Corellation of Mutations, TILs and Age in Breast CancerGenetic

Study groups in NCT04033965
Study groupRoleWhat they receive
women <35 with early breast cancerNot described
Receives: Genetic: Corellation of Mutations, TILs and Age in Breast Cancer
women>65 years old with early breast cancerNot described
Receives: Genetic: Corellation of Mutations, TILs and Age in Breast Cancer

What is being measured

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

  1. Assessment of the prevalence of gene mutations in women <=35 years old with early breast cancer.

    Measured: Up to 13 years

  2. Assessment of the prevalence of gene mutations in women >65years old with early breast cancer.

    Measured: Up to 13 years

  3. Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women <=35 years old with early breast cancer.

    Measured: Up to 13 years

  4. Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women >65 years old with early breast cancer.

    Measured: Up to 13 years

  5. Evaluation of the prognostic effect of gene mutations and Tumor Infiltrating Lymphocytes with respect to Overall Survival in women <=35 years old with early breast cancer

    Measured: Up to 13 years

  6. Evaluation of the prognostic effect of gene mutations and Tumor Infiltrating Lymphocytes with respect to Overall Survival in women >65 years old with early breast cancer.

    Measured: Up to 13 years

Timeline

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

  1. First posted26 Jul 2019
  2. Study start3 Sep 1997
  3. Primary completion1 Oct 2010
  4. Study completion1 Oct 2010

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04033965
Sponsor's protocol ID
HE10/mut
Status last verified
Jul 2019
First submitted
16 Jul 2019
Last updated
26 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gnerlich JL, Deshpande AD, Jeffe DB, Sweet A, White N, Margenthaler JA. Elevated breast cancer mortality in women younger than age 40 years compared with older women is attributed to poorer survival in early-stage disease. J Am Coll Surg. 2009 Mar;208(3):341-7. doi: 10.1016/j.jamcollsurg.2008.12.001. Epub 2009 Jan 21.

    PubMed 19317994

  • Stickeler E. Prognostic and Predictive Markers for Treatment Decisions in Early Breast Cancer. Breast Care (Basel). 2011;6(3):193-198. doi: 10.1159/000329471. Epub 2011 Jun 14.

    PubMed 21779224

  • Bonnier P, Romain S, Charpin C, Lejeune C, Tubiana N, Martin PM, Piana L. Age as a prognostic factor in breast cancer: relationship to pathologic and biologic features. Int J Cancer. 1995 Jul 17;62(2):138-44. doi: 10.1002/ijc.2910620205.

    PubMed 7622286

  • Sweeney C, Blair CK, Anderson KE, Lazovich D, Folsom AR. Risk factors for breast cancer in elderly women. Am J Epidemiol. 2004 Nov 1;160(9):868-75. doi: 10.1093/aje/kwh276.

    PubMed 15496539

  • Gomez-Flores-Ramos L, Castro-Sanchez A, Pena-Curiel O, Mohar-Betancourt A. Molecular Biology In Young Women With Breast Cancer: From Tumor Gene Expression To DNA Mutations. Rev Invest Clin. 2017 Jul-Aug;69(4):181-192. doi: 10.24875/ric.17002225.

    PubMed 28776603

  • Azim HA Jr, Partridge AH. Biology of breast cancer in young women. Breast Cancer Res. 2014 Aug 27;16(4):427. doi: 10.1186/s13058-014-0427-5.

    PubMed 25436920

  • Aebi S, Gelber S, Castiglione-Gertsch M, Gelber RD, Collins J, Thurlimann B, Rudenstam CM, Lindtner J, Crivellari D, Cortes-Funes H, Simoncini E, Werner ID, Coates AS, Goldhirsch A. Is chemotherapy alone adequate for young women with oestrogen-receptor-positive breast cancer? Lancet. 2000 May 27;355(9218):1869-74. doi: 10.1016/s0140-6736(00)02292-3.

    PubMed 10866443

  • Arriagada R, Le MG, Dunant A, Tubiana M, Contesso G. Twenty-five years of follow-up in patients with operable breast carcinoma: correlation between clinicopathologic factors and the risk of death in each 5-year period. Cancer. 2006 Feb 15;106(4):743-50. doi: 10.1002/cncr.21659.

    PubMed 16411216

  • Goldhirsch A, Gelber RD, Yothers G, Gray RJ, Green S, Bryant J, Gelber S, Castiglione-Gertsch M, Coates AS. Adjuvant therapy for very young women with breast cancer: need for tailored treatments. J Natl Cancer Inst Monogr. 2001;(30):44-51. doi: 10.1093/oxfordjournals.jncimonographs.a003459.

    PubMed 11773291

  • Kroman N, Jensen MB, Wohlfahrt J, Mouridsen HT, Andersen PK, Melbye M. Factors influencing the effect of age on prognosis in breast cancer: population based study. BMJ. 2000 Feb 19;320(7233):474-8. doi: 10.1136/bmj.320.7233.474.

    PubMed 10678859

  • Encinas G, Sabelnykova VY, de Lyra EC, Hirata Katayama ML, Maistro S, de Vasconcellos Valle PWM, de Lima Pereira GF, Rodrigues LM, de Menezes Pacheco Serio PA, de Gouvea ACRC, Geyer FC, Basso RA, Pasini FS, Del Pilar Esteves Diz M, Brentani MM, Guedes Sampaio Goes JC, Chammas R, Boutros PC, Koike Folgueira MAA. Somatic mutations in early onset luminal breast cancer. Oncotarget. 2018 Apr 27;9(32):22460-22479. doi: 10.18632/oncotarget.25123. eCollection 2018 Apr 27.

    PubMed 29854292

  • Kotoula V, Karavasilis V, Zagouri F, Kouvatseas G, Giannoulatou E, Gogas H, Lakis S, Pentheroudakis G, Bobos M, Papadopoulou K, Tsolaki E, Pectasides D, Lazaridis G, Koutras A, Aravantinos G, Christodoulou C, Papakostas P, Markopoulos C, Zografos G, Papandreou C, Fountzilas G. Effects of TP53 and PIK3CA mutations in early breast cancer: a matter of co-mutation and tumor-infiltrating lymphocytes. Breast Cancer Res Treat. 2016 Jul;158(2):307-21. doi: 10.1007/s10549-016-3883-z. Epub 2016 Jul 1.

    PubMed 27369359

  • Papaxoinis G, Kotoula V, Alexopoulou Z, Kalogeras KT, Zagouri F, Timotheadou E, Gogas H, Pentheroudakis G, Christodoulou C, Koutras A, Bafaloukos D, Aravantinos G, Papakostas P, Charalambous E, Papadopoulou K, Varthalitis I, Efstratiou I, Zaramboukas T, Patsea H, Scopa CD, Skondra M, Kosmidis P, Pectasides D, Fountzilas G. Significance of PIK3CA Mutations in Patients with Early Breast Cancer Treated with Adjuvant Chemotherapy: A Hellenic Cooperative Oncology Group (HeCOG) Study. PLoS One. 2015 Oct 9;10(10):e0140293. doi: 10.1371/journal.pone.0140293. eCollection 2015.

    PubMed 26452060

  • Kotoula V, Chatzopoulos K, Lakis S, Alexopoulou Z, Timotheadou E, Zagouri F, Pentheroudakis G, Gogas H, Galani E, Efstratiou I, Zaramboukas T, Koutras A, Aravantinos G, Samantas E, Psyrri A, Kourea H, Bobos M, Papakostas P, Kosmidis P, Pectasides D, Fountzilas G. Tumors with high-density tumor infiltrating lymphocytes constitute a favorable entity in breast cancer: a pooled analysis of four prospective adjuvant trials. Oncotarget. 2016 Jan 26;7(4):5074-87. doi: 10.18632/oncotarget.6231.

    PubMed 26506242

  • Kotoula V, Lyberopoulou A, Papadopoulou K, Charalambous E, Alexopoulou Z, Gakou C, Lakis S, Tsolaki E, Lilakos K, Fountzilas G. Evaluation of two highly-multiplexed custom panels for massively parallel semiconductor sequencing on paraffin DNA. PLoS One. 2015 Jun 3;10(6):e0128818. doi: 10.1371/journal.pone.0128818. eCollection 2015.

    PubMed 26039550

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Hellenic Cooperative Oncology Group.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assessment of the prevalence of gene mutations in women <=35 years old with early breast cancer. (time frame: Up to 13 years). The study lists 6 primary outcomes in all. 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 NCT04033965, which also lists 32 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 26 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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