Breast Cancer FemaleNCT06050109
The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
An observational study of Breast Cancer Female and Endocrine Therapy, run by Hongmei Zheng, PhD at 1 site in China.
Trial summary
To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS. This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer Female, Endocrine Therapy
- What is being tested?
- OFS continues to use group after 5 years use and Immunohistochemical detection of HR status
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2028
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who are diagnosed as early breast cancer and have received 5 years treatment of OFS.
Who may be able to join
- Diagnosed with early primary breast cancer
- Female aged 18-60 years (including 18 year and 60 year)
- Hormone receptor (HR) positive HER2 negative
- Receive 5 years of OFS treatment
- ECOG score 0-1
- Voluntarily join this study and sign the informed consent form;
- The researcher believes that it can benefit.
Who cannot join
- The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years
- Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision
- Invasive metastases with known obvious symptoms
- Invasive metastases with known obvious symptoms
- Doctors think it is not suitable for inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wu Xinhong
Wuhan, Hubei
xinhong wu, Dr, +8618602726300, wuxinhong_9@sina.com
About this study
Official title: A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing the Benefits of Continued Use of Ovarian Function Suppression After 5 Years
To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.
This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.
- Conditions
- Breast Cancer Female, Endocrine Therapy
- Being tested
- OFS continues to use group after 5 years use, Immunohistochemical detection of HR status
- Keywords
- ovarian function suppression, Hormone receptor (HR) positive, HER2 negative, early breast cancer, prolonged therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFS continues to use group after 5 years useDrug
Also called OFS discontinues to use group after 5 years use
Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use.
Immunohistochemical detection of HR statusDiagnostic test
Enrolled patients must be HR-positive premenopausal breast cancer patients
| Study group | Role | What they receive |
|---|---|---|
| OFS continues to use after 5 years | HR-positive premenopausal female patients whose doctors believe that they can benefit from continued use of OFS after 5 years should be included in the trial group. Receives: Drug: OFS continues to use group after 5 years use; Diagnostic Test: Immunohistochemical detection of HR status | |
| OFS discontinues to use after 5 years | The control group did not need to continue to use OFS, either leuprolide or goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive disease-free survival
The main effect evaluation index was invasive disease-free survival (iDFS)
Measured: 5 years
Secondary outcomes (1)
Overall survival
Overall survival for years, which means the rate of patients alive in the whole patients at the same group will be calculated with kaplan meier survival curves.
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 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongmei Zheng, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongmei Zheng, PhD, Hubei Cancer Hospital
- Investigators
- Hongmei Zheng, Doctor, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050109
- Sponsor's protocol ID
- HBCHBCC001
- Status last verified
- Oct 2024
- First submitted
- 17 Sep 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing the Benefits of Continued Use of Ovarian Function Suppression After 5 Years
- ClinicalTrials.gov ID
- NCT06050109
- Acronym / sponsor ID
- HBCHBCC001
- Conditions
- Breast Cancer Female, Endocrine Therapy
- Keywords
- ovarian function suppression, Hormone receptor (HR) positive, HER2 negative, early breast cancer, prolonged therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Hongmei Zheng, PhDUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 22 Sep 2023 (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.
To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.
This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFS continues to use after 5 years | – | Drug: OFS continues to use group after 5 years use, Diagnostic Test: Immunohistochemical detection of HR statusHR-positive premenopausal female patients whose doctors believe that they can benefit from continued use of OFS after 5 years should be included in the trial group. |
| OFS discontinues to use after 5 years | – | –The control group did not need to continue to use OFS, either leuprolide or goserelin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who are diagnosed as early breast cancer and have received 5 years treatment of OFS.
Key inclusion criteria (7 listed)
- Diagnosed with early primary breast cancer
- Female aged 18-60 years (including 18 year and 60 year)
- Hormone receptor (HR) positive HER2 negative
- Receive 5 years of OFS treatment
- ECOG score 0-1
Key exclusion criteria (5 listed)
- The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years
- Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision
- Invasive metastases with known obvious symptoms
- Invasive metastases with known obvious symptoms
- Doctors think it is not suitable for inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFS continues to use group after 5 years useAlso: OFS discontinues to use group after 5 years usePatients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use. | Drug | OFS continues to use after 5 years |
| Immunohistochemical detection of HR statusEnrolled patients must be HR-positive premenopausal breast cancer patients | Diagnostic test | OFS continues to use after 5 years |
Primary outcome
invasive disease-free survival
Time frame: 5 years
The main effect evaluation index was invasive disease-free survival (iDFS)
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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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.
Hongmei Zheng, Doctor principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Endocrine Therapy, run by Hongmei Zheng, PhD 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 7 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 17 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 Hongmei Zheng, Doctor (18971624606 ext. +86, zhenghongmeicj@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 (time frame: 5 years). 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 17 Mar 2025.