Breast Cancer FemalesNCT07180914
A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer
An observational study of Breast Cancer Females, run by Zhejiang Cancer Hospital.
Trial summary
The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer. The study also aims to understand the compliance with and reasons for discontinuing adjuvant OFS endocrine therapy under different combination regimens. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Females
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2025to 31 Dec 2029
- How long will I take part?
- 3 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Female breast cancer patients who were premenopausal at the time of surgery. 2. Newly diagnosed patients with invasive breast cancer, TNM stage I-III. 3. HR-positive (defined as ER ≥ 10% and/or PR ≥ 10%). 4. Patients who have undergone radical mastectomy and are planning to receive OFS treatment. 5. Have received (neo)adjuvant chemotherapy and radiotherapy. 6. ECOG PS score of 0-1. 7. Complete medical records. 8. Willing to accept long-term follow-up. 9. Any adverse events that occurred during adjuvant chemotherapy (if applicable) have recovered or decreased to grade 1 (according to CTCAE v5.0) at the start of OFS treatment.
Who may be able to join
- Female breast cancer patients who were premenopausal at the time of surgery.
- Newly diagnosed patients with invasive breast cancer, tumor node metastasis(TNM) stage I-III.
- HR-positive (defined as ER ≥ 10% and/or progesterone receptor(PR) ≥ 10%).
- Patients who have undergone radical mastectomy and are planning to receive OFS treatment.
- Have received (neo)adjuvant chemotherapy and radiotherapy.
- Eastern Cooperative Oncology Group Performance Status(ECOG PS) score of 0-1.
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- Complete medical records.
- Willing to accept long-term follow-up.
- Any adverse events that occurred during adjuvant chemotherapy (if applicable) have recovered or decreased to grade 1 (according to CTCAE v5.0) at the start of OFS treatment.
Who cannot join
- Simultaneously participating in another blinded clinical study.
- Presence of other active malignant tumors or multiple primary cancers.
- Pregnant or lactating women.
- Other conditions that the investigator deems unsuitable for inclusion in the study.
- Planning to use systemic therapies not described in the study cohort during the endocrine therapy phase (such as, but not limited to, chemotherapy, Antibody-Drug Conjugates(ADCs), or immunotherapy).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for HR+ Premenopausal Breast Cancer
The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer. The study also aims to understand the compliance with and reasons for discontinuing adjuvant OFS endocrine therapy under different combination regimens.
The main questions it aims to answer are:
Read more
- What are the rates of compliance with and reasons for discontinuation of adjuvant OFS endocrine therapy?
- What is the impact of OFS treatment duration on patient prognosis?
Participants, who are already receiving OFS treatment as part of their regular medical care, will have their demographic data, treatment status, clinical outcomes, and adverse events collected over time.
Read the detailed description
This real-world non-interventional prospective study aims to explore the compliance and reasons for discontinuation of adjuvant OFS endocrine therapy in early HR-positive premenopausal breast cancer patients under different combination regimens of adjuvant endocrine drugs, as well as to observe the impact of the duration of OFS treatment on prognosis. This study adopts a multi-center, prospective, non-interventional design to collect approximately 300 cases of early HR-positive premenopausal breast cancer patients who received OFS treatment. After obtaining informed consent, the demographic data, breast cancer diagnosis information, comorbidities, past medical history, treatment status, clinical outcomes, and adverse events of the patients were collected. The patients were administered medication in accordance with the standard clinical drug protocols and completed follow-up according to the follow-up plan.
- Conditions
- Breast Cancer Females
- Keywords
- OFS, Hormone receptor positive, Early-stage 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.
| Study group | Role | What they receive |
|---|---|---|
| Early-stage HR-positive premenopausal breast cancer patients receiving OFS treatment. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation.
The proportion of patients who discontinue OFS within 2 years.
Measured: Follow-up will be conducted every 3 months during the period from baseline to 2 years of endocrine therapy.
Secondary outcomes (4)
Effect of OFS Treatment Duration on Prognosis.
To observe the effect of OFS treatment duration on prognosis.
Measured: 3-year iDFS rate for OFS treatment duration ≥2 years and <2 years
3-year iDFS for Different OFS Combination Regimens.
3-year iDFS for different OFS combination therapy regimens.
Measured: 3 years.
Safety of different combination regimens
The collection and analysis of various adverse events and serious adverse events that occur during different treatment processes.
Measured: During the follow-up period, which is every 3 months within the first 2 years, and every 6 months from year 2 to year 3
3-year iDFS of different subgroups
The 3-year invasive disease-free survival (iDFS) for different patient subgroups.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start10 Oct 2025 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemalesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Health Promotion Association
- Responsible party
- Principal investigator, Yu Yang, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180914
- Sponsor's protocol ID
- IRB-2025-977
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for HR+ Premenopausal Breast Cancer
- ClinicalTrials.gov ID
- NCT07180914
- Acronym / sponsor ID
- IRB-2025-977
- Conditions
- Breast Cancer Females
- Keywords
- OFS, Hormone receptor positive, Early-stage breast cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Beijing Health Promotion Association
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Sep 2025 (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.
The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer. The study also aims to understand the compliance with and reasons for discontinuing adjuvant OFS endocrine therapy under different combination regimens.
The main questions it aims to answer are:
- What are the rates of compliance with and reasons for discontinuation of adjuvant OFS endocrine therapy?
- What is the impact of OFS treatment duration on patient prognosis?
Participants, who are already receiving OFS treatment as part of their regular medical care, will have their demographic data, treatment status, clinical outcomes, and adverse events collected over time.
Detailed description
This real-world non-interventional prospective study aims to explore the compliance and reasons for discontinuation of adjuvant OFS endocrine therapy in early HR-positive premenopausal breast cancer patients under different combination regimens of adjuvant endocrine drugs, as well as to observe the impact of the duration of OFS treatment on prognosis. This study adopts a multi-center, prospective, non-interventional design to collect approximately 300 cases of early HR-positive premenopausal breast cancer patients who received OFS treatment. After obtaining informed consent, the demographic data, breast cancer diagnosis information, comorbidities, past medical history, treatment status, clinical outcomes, and adverse events of the patients were collected. The patients were administered medication in accordance with the standard clinical drug protocols and completed follow-up according to the follow-up plan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early-stage HR-positive premenopausal breast cancer patients receiving OFS treatment. | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Female breast cancer patients who were premenopausal at the time of surgery. 2. Newly diagnosed patients with invasive breast cancer, TNM stage I-III. 3. HR-positive (defined as ER ≥ 10% and/or PR ≥ 10%). 4. Patients who have undergone radical mastectomy and are planning to receive OFS treatment. 5. Have received (neo)adjuvant chemotherapy and radiotherapy. 6. ECOG PS score of 0-1. 7. Complete medical records. 8. Willing to accept long-term follow-up. 9. Any adverse events that occurred during adjuvant chemotherapy (if applicable) have recovered or decreased to grade 1 (according to CTCAE v5.0) at the start of OFS treatment.
Key inclusion criteria (9 listed)
- Female breast cancer patients who were premenopausal at the time of surgery.
- Newly diagnosed patients with invasive breast cancer, tumor node metastasis(TNM) stage I-III.
- HR-positive (defined as ER ≥ 10% and/or progesterone receptor(PR) ≥ 10%).
- Patients who have undergone radical mastectomy and are planning to receive OFS treatment.
- Have received (neo)adjuvant chemotherapy and radiotherapy.
Key exclusion criteria (5 listed)
- Simultaneously participating in another blinded clinical study.
- Presence of other active malignant tumors or multiple primary cancers.
- Pregnant or lactating women.
- Other conditions that the investigator deems unsuitable for inclusion in the study.
- Planning to use systemic therapies not described in the study cohort during the endocrine therapy phase (such as, but not limited to, chemotherapy, Antibody-Drug Conjugates(ADCs), or immunotherapy).
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
Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation.
Time frame: Follow-up will be conducted every 3 months during the period from baseline to 2 years of endocrine therapy.
The proportion of patients who discontinue OFS within 2 years.
4 secondary outcomes
Effect of OFS Treatment Duration on Prognosis.
Time frame: 3-year iDFS rate for OFS treatment duration ≥2 years and <2 years
3-year iDFS for Different OFS Combination Regimens.
Time frame: 3 years.
Safety of different combination regimens
Time frame: During the follow-up period, which is every 3 months within the first 2 years, and every 6 months from year 2 to year 3
3-year iDFS of different subgroups
Time frame: 3 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 18 Sep 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Females, 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 9 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: opening soon, as of the sponsor's last update on 18 Sep 2025. 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?
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 Yang Yu (+8613958013303, yuyangkaiyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to different Ovarian Function Suppression (OFS) combination regimens and reasons for discontinuation. (time frame: Follow-up will be conducted every 3 months during the period from baseline to 2 years of endocrine therapy.). 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 18 Sep 2025.