Breast CancerNCT06313476
AMH Predicts Postchemotherapy Menopause in Premenopausal Breast Cancer Patients
An observational study of Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause Read more about this study
- Who is it for?
- Ages 40 to 59 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 30 Apr 2026
- 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 40 to 59 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal early breast cancer patients who do not use OFS as ovarian suppression after receiving chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) at the Breast Tumor Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Who may be able to join
- Age over 40(include 40 years old), or before 60, female
- Primary invasive breast cancer diagnosed by histopathology, except of occult breast cancer, inflammatory breast cancer and Paget's disease
- Operable patients with no distant metastases at diagnosis (stage T1-T3, any N, M0)
- The patient was at premenopausal status when first diagnosed (had menstruation in the last 12 months or hormone levels not reached menopause when diagnosed, E2 > 30ng/L, FSH≤30U/L)
- The patient has used chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) after diagnosis
Who cannot join
- Age before 40, or over 60(include 60 years old)
- Patient who accepted bilateral ovariectomy or ovarian radiotherapy
- Patient who used gonadotropin-releasing hormone agonist ( GnRHa)
- Stage IV (metastatic) breast cancer
- The patient was at postmenopausal status when first diagnosed (no menstruation in the past 12 months or hormone levels reached menopause when diagnosed, E2≤30ng/L, FSH > 30U/L)
- The patient has not used chemotherapy (neoadjuvant or adjuvant chemotherapy) since diagnosis
- The investigator determines that the patient has any other condition that make her unfit to participate in the study
About this study
Official title: A Prospective, Observational Clinical Study of AMH Predicting Postchemotherapy Menopause in Premenopausal Breast Cancer Patients Who do Not Use OFS
To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause
Read the detailed description
For early breast cancer women who are premenopausal, after receiving chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy), not using OFS as ovarian suppression, AMH, E2 and FSH levels will be measured by blood sampling before chemotherapy, at the end of chemotherapy and 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after chemotherapy. The menstrual status of patients will be also followed up. At several timing, investigators will analyze AMH level, E2 level, FSH level, proportion of unmeasured AMH (AMH≤0.02ng/ml), proportion of E2 that conforms to menopausal status (E2≤30ng/L), proportion of FSH that conforms to menopausal status (FSH > 30U/L), proportion of persistent amenia (no menstruation from the end of chemotherapy to the evaluation time) and incidence of adverse reactions
- Conditions
- 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 |
|---|---|---|
| Patients | Premenopausal patients with early breast cancer who received chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) and did not use OFS ovarian suppression at the Breast Cancer Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Mullerian Hormone
Blood Test
Measured: Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Secondary outcomes (3)
Estradiol
Blood Test
Measured: Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Follicle Stimulating Hormone
Blood Test
Measured: Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Menstruation
Follow-up
Measured: Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313476
- Sponsor's protocol ID
- SYSKY-2024-030-01
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Clinical Study of AMH Predicting Postchemotherapy Menopause in Premenopausal Breast Cancer Patients Who do Not Use OFS
- ClinicalTrials.gov ID
- NCT06313476
- Acronym / sponsor ID
- SYSKY-2024-030-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 15 Mar 2024 (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 determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause
Detailed description
For early breast cancer women who are premenopausal, after receiving chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy), not using OFS as ovarian suppression, AMH, E2 and FSH levels will be measured by blood sampling before chemotherapy, at the end of chemotherapy and 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after chemotherapy. The menstrual status of patients will be also followed up. At several timing, investigators will analyze AMH level, E2 level, FSH level, proportion of unmeasured AMH (AMH≤0.02ng/ml), proportion of E2 that conforms to menopausal status (E2≤30ng/L), proportion of FSH that conforms to menopausal status (FSH > 30U/L), proportion of persistent amenia (no menstruation from the end of chemotherapy to the evaluation time) and incidence of adverse reactions
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Premenopausal patients with early breast cancer who received chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) and did not use OFS ovarian suppression at the Breast Cancer Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal early breast cancer patients who do not use OFS as ovarian suppression after receiving chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) at the Breast Tumor Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Key inclusion criteria (5 listed)
- Age over 40(include 40 years old), or before 60, female
- Primary invasive breast cancer diagnosed by histopathology, except of occult breast cancer, inflammatory breast cancer and Paget's disease
- Operable patients with no distant metastases at diagnosis (stage T1-T3, any N, M0)
- The patient was at premenopausal status when first diagnosed (had menstruation in the last 12 months or hormone levels not reached menopause when diagnosed, E2 > 30ng/L, FSH≤30U/L)
- The patient has used chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) after diagnosis
Key exclusion criteria (7 listed)
- Age before 40, or over 60(include 60 years old)
- Patient who accepted bilateral ovariectomy or ovarian radiotherapy
- Patient who used gonadotropin-releasing hormone agonist ( GnRHa)
- Stage IV (metastatic) breast cancer
- The patient was at postmenopausal status when first diagnosed (no menstruation in the past 12 months or hormone levels reached menopause when diagnosed, E2≤30ng/L, FSH > 30U/L)
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
Anti-Mullerian Hormone
Time frame: Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Blood Test
3 secondary outcomes
Estradiol
Time frame: Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Follicle Stimulating Hormone
Time frame: Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Menstruation
Time frame: Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 5 inclusion and 7 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 15 Mar 2024. 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?
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?
Anti-Mullerian Hormone (time frame: Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy). 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 15 Mar 2024.