Breast CancerNCT04972448
RecurIndex Predicts Risk of Recurrence in Early-stage Luminal Breast Cancer
An observational study of Breast Cancer and Recurrence, run by Zhejiang Cancer Hospital.
Trial summary
This study will conduct a multicenter, open, prospective clinical trial to observe the RecurIndex to assist in predicting the risk of recurrence in patients with early-stage Luminal-type breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Recurrence
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Nov 2025
- 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 to 70 years
- Women only
- Adult, Older adult
Study population: Women with breast cancer
Who may be able to join
- Age ≥ 18 years old, ≤ 70 years old.
- Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- Postoperative pathology is clearly diagnosed as invasive breast cancer.
- Estrogen receptor (ER) or progesterone receptor (PR) positive, HER2 negative.
- Available with Formalin-Fixed and Parrffin-Embedded (FFPE) tumor tissue.
- Stage I-II patients who have received surgery (breast-conserving or mastectomy) and the pathological staging is pT1-2N0-1M0 or pT3N0M0.
- The patient had not received systemic systemic treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy) before enrollment.
- Signed an informed consent form.
Who cannot join
- Breast cancer patients whose clinical or pathological stage is T4, N2-3 or M1.
- Known human immunodeficiency virus infection (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases.
- Other psychiatric disorders that may interfere with the judgment of the study results, or abnormal laboratory tests; and who, in the judgment of the investigator, are considered unfit to participate in the study.
- Patients with double breast cancer.
- Severe/uncontrolled intercurrent diseases/infections.
- Subjects with allogeneic organ transplants requiring immunosuppressive therapy.
- Hormone receptors ER and PR are negative (any detectable estrogen and progesterone receptors do not express or express <1%) and/or HER2 overexpression/amplified by FISH detection.
- Not suitable for hormone receptor modulators (e.g. tamoxifen) and adjuvant endocrine other drug therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Clinical Translational Study on the Multi-gene Assays and RecurIndex for Predicting the Breast Cancer Recurrence Risk in Cross-strait Chinese Patients With Early-stage Luminal Breast Cancer
This study will conduct a multicenter, open, prospective clinical trial to observe the RecurIndex to assist in predicting the risk of recurrence in patients with early-stage Luminal-type breast cancer. The aim of this study is to validate the predictive effect of the RecurIndex on the risk of recurrence in women with early-stage Luminal-type breast cancer in China.
- Conditions
- Breast Cancer, Recurrence
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Chemotherapy+endocrine therapy+radiotherapy | |
| Group2 | Chemotherapy+endocrine therapy | |
| Group3 | endocrine therapy+radiotherapy | |
| Group4 | endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive disease-free survival (IDFS)
defined as time between treatment and the time of invasive disease occurred
Measured: 5 years
recurrence free survival (RFS)
defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Measured: 5 years
Secondary outcomes (3)
overall survival (OS)
defined as time between treatment and the time of death occurred
Measured: 5 years
distance metastasis-free interval (DMFI)
defined as time between treatment and the time of distant metastases, or death
Measured: 5 years
local-regional recurrence-free interval (LRFI)
defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiajia Wang, MD, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972448
- Sponsor's protocol ID
- ZhejiangCH-0709
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Translational Study on the Multi-gene Assays and RecurIndex for Predicting the Breast Cancer Recurrence Risk in Cross-strait Chinese Patients With Early-stage Luminal Breast Cancer
- ClinicalTrials.gov ID
- NCT04972448
- Acronym / sponsor ID
- ZhejiangCH-0709
- Conditions
- Breast Cancer, Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will conduct a multicenter, open, prospective clinical trial to observe the RecurIndex to assist in predicting the risk of recurrence in patients with early-stage Luminal-type breast cancer. The aim of this study is to validate the predictive effect of the RecurIndex on the risk of recurrence in women with early-stage Luminal-type breast cancer in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | –Chemotherapy+endocrine therapy+radiotherapy |
| Group2 | – | –Chemotherapy+endocrine therapy |
| Group3 | – | –endocrine therapy+radiotherapy |
| Group4 | – | –endocrine therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer
Key inclusion criteria (8 listed)
- Age ≥ 18 years old, ≤ 70 years old.
- Eastern Cooperative Oncology Group (ECOG) ≤ 2.
- Postoperative pathology is clearly diagnosed as invasive breast cancer.
- Estrogen receptor (ER) or progesterone receptor (PR) positive, HER2 negative.
- Available with Formalin-Fixed and Parrffin-Embedded (FFPE) tumor tissue.
Key exclusion criteria (8 listed)
- Breast cancer patients whose clinical or pathological stage is T4, N2-3 or M1.
- Known human immunodeficiency virus infection (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases.
- Other psychiatric disorders that may interfere with the judgment of the study results, or abnormal laboratory tests; and who, in the judgment of the investigator, are considered unfit to participate in the study.
- Patients with double breast cancer.
- Severe/uncontrolled intercurrent diseases/infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
invasive disease-free survival (IDFS)
Time frame: 5 years
defined as time between treatment and the time of invasive disease occurred
recurrence free survival (RFS)
Time frame: 5 years
defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
3 secondary outcomes
overall survival (OS)
Time frame: 5 years
distance metastasis-free interval (DMFI)
Time frame: 5 years
local-regional recurrence-free interval (LRFI)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiajia Wang, MD study chair
Zhejiang Cancer Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Recurrence, run by Zhejiang Cancer Hospital.
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 8 inclusion and 8 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 22 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Lei, MD (13750802564, leilei1241@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
invasive disease-free survival (IDFS) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2021.