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Breast Cancer MetastaticQiluElderHopeNCT06891651

21-gene in Elder Breast Cancer Patients With Lymph Node Metastasis

An observational study of Breast Cancer Metastatic and Breast Cancer Survival, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

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

Sites and contacts
Official record
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Trial summary

This study is a single-center, bidirectional cohort study. It aims to include 35 elderly (≥65 years old) Luminal A type breast cancer patients with axillary lymph node metastasis after surgery as the research subjects. Read more about this study

Who is it for?
Ages 65 years and older, women only
How many people
35 participants
Where
1 siteChina
Study dates
1 Dec 2024to 31 Dec 2034
How long will I take part?
10 Years
Phase
Observational
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 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Study population: Qilu hospital of Shandong University or its medical alliance hospital

Who may be able to join

  • Sign a written informed consent；
  • Female, age ≥ 65 years old；
  • Patients who have undergone radical surgery for breast cancer (radical surgery refers to modified radical mastectomy, radical mastectomy or simple mastectomy + axillary lymph node dissection), and have been histologically confirmed to have axillary lymph node metastasis after surgery；
  • Postoperative immunohistochemical typing and pTNM staging meet the following criteria:
  • Luminal A type (ER and PR positive with a positive rate ≥ 20%, Her-2 gene negative, Ki67 < 15%), with pTNM staging of pTanyNanyM0.
  • Or Luminal B, Her-2 gene negative type, with ER and PR positive and a positive rate ≥ 20%, Ki67 ≤ 30%, and pTNM staging of pTanyN1M0.
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  • Or age ≥ 70 years old, Luminal B, Her-2 gene negative type, with ER and PR positive and a positive rate ≥ 20%, Ki67 ≤ 30%, and pTNM staging of pTanyNanyM0.
  • Or age ≥ 70 years old, but refuse or are unable to tolerate chemotherapy treatment, ER or PR positive, with pTNM staging of pTanyNanyM0；
  • ECOG score 0-1；
  • Expected survival time > 6 months.

Who cannot join

  • Patients who have received preoperative neoadjuvant therapy in the past;
  • Patients with bilateral breast cancer;
  • Patients whose paraffin tissue specimens have been stored for more than 3 years at the start of the project;
  • Patients with mental disorders who are unable to cooperate with subsequent treatment and follow-up;
  • Patients with a history or evidence of disease, treatment or abnormal laboratory test values that may interfere with the trial results or prevent full participation in the study, or other situations deemed unsuitable for inclusion by the researcher, or those considered to have other potential risks and thus not suitable for participation in this study.

Trial locations and contacts

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

Jiang Zhu, M.D. & Ph.D. contact

（+86）18560085173

zhujiang@qiluhospital.com

Xiao Wang, M.D. & Ph.D. contact

（+86）18560081170

wangxiao08@sdu.edu.cn

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Siqi Cui, （+86）18560085451, cuisiqi10135@qiluhospital.com

    Song Zhao, M.D. & Ph.D.

    Recruiting

Other trials in China

About this study

Official title: Clinical Cohort Study of 21-gene Assay in Predicting the Prognosis of Elder Luminal-A Breast Cancer Patients With Axillary Lymph Node Metastasis

This study is a single-center, bidirectional cohort study. It aims to include 35 elderly (≥65 years old) Luminal A type breast cancer patients with axillary lymph node metastasis after surgery as the research subjects. After signing the informed consent, the patients who meet the inclusion criteria will have their various clinical and pathological data collected (preoperative imaging examinations, clinical and pathological information of the patients, basic disease conditions and medication strategies, surgical records, postoperative planned treatment plans and actual treatment situations, etc.), and their real adjuvant treatment situations (whether chemotherapy, radiotherapy, endocrine therapy, targeted therapy, etc. were performed after surgery) will be followed up and recorded. At the same time, paraffin tissues of breast cancer and metastatic lymph nodes of the patients will be collected from the pathology department of our hospital for 21-gene assay, and the recurrence risk index of the primary lesion and metastatic lymph nodes will be obtained using the risk index calculation logic of Amoy Diagnostics Company. An assessment will be conducted every 12 months after surgery until disease recurrence. After disease recurrence, survival follow-up will be conducted every three months until the patient's death. The predictive value of 21-gene assay for patient survival and whether chemotherapy is beneficial will be evaluated based on the follow-up data of the patients.

Keywords
Breast cancer, 21-gene assay, Axillary lymph node metastasis
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT06891651
Study groupRoleWhat they receive
21-gene assay in elder breast cancer with axillary lymph node metastasis21-gene assay will be performed not only in primary cancer site in breast but also in metastatic lymph nodes.

What is being measured

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

  1. Whether elderly Luminal-A breast cancer patients with axillary lymph node metastasis could benefit from 21-gene assay.

    All analyses will be conducted using SPSS 22.0. Comparisons between groups will be reported with 95% confidence intervals and p-values. Continuous variables will be presented as mean ± SD or median (min, max) based on distribution normality. Categorical variables will be described using frequencies (%).

    Disease-Free Survival (DFS) Unit of measure: Months from postoperative baseline Assessment: Time to first radiological recurrence (RECIST v1.1) or death Method: Kaplan-Meier analysis with log-rank test

    Measured: From enrollment to 80 years old（Average life expectancy）or mortality.

Secondary outcomes (1)

  1. Whether elderly Luminal-A breast cancer patients with axillary lymph node metastasis could benefit from 21-gene assay

    Overall Survival (OS) Unit of measure: Months from enrollment Assessment: Time to all-cause mortality Method: Kaplan-Meier analysis

    Measured: From enrollment to 80 years old（Average life expectancy）or mortality.

Timeline

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

  1. First posted24 Mar 2025
  2. Study start1 Dec 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2034 (estimated)

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
Other
Enrolment
35 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06891651
Sponsor's protocol ID
KYLL-202407-026-1
Other IDs
26010112002346
Acronym
QiluElderHope
Status last verified
Oct 2024
First submitted
21 Feb 2025
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bertagnolli MM, Singh H. Treatment of Older Adults with Cancer - Addressing Gaps in Evidence. N Engl J Med. 2021 Sep 16;385(12):1062-1065. doi: 10.1056/NEJMp2106089. Epub 2021 Sep 11. No abstract available.

    PubMed 34506087

  • Lin J, Guo Z, Wang S, Zheng X. Omission of Chemotherapy in HR+/HER2- Early Invasive Breast Cancer Based on Combined 6-IHC Score? Clin Breast Cancer. 2021 Oct;21(5):e565-e574. doi: 10.1016/j.clbc.2021.01.011. Epub 2021 Jan 23.

    PubMed 33674187

  • Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin PM, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW Jr. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):111-121. doi: 10.1056/NEJMoa1804710. Epub 2018 Jun 3.

    PubMed 29860917

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.

    PubMed 35020204

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Metastatic and Breast Cancer Survival, run by Qilu Hospital of Shandong University at 1 site in China.

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 10 inclusion and 5 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 24 Mar 2025. 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 China. 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 Jiang Zhu, M.D. & Ph.D. (（+86）18560085173, zhujiang@qiluhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whether elderly Luminal-A breast cancer patients with axillary lymph node metastasis could benefit from 21-gene assay. (time frame: From enrollment to 80 years old（Average life expectancy）or mortality.). 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 NCT06891651, which also lists 4 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 2025.

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