Why do some breast cancer patients quit hormone therapy? new study aims to find out
NCT ID NCT07180914
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This observational study will follow 300 premenopausal women with HR-positive early breast cancer who are already receiving ovarian function suppression (OFS) therapy as part of their routine care. Researchers want to see how many patients stop OFS within two years and why, and whether the length of treatment affects cancer outcomes. The goal is to improve long-term treatment adherence and prognosis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ovarian Function Suppression (OFS) therapy
- What this could lead to
- If successful, this study could help doctors understand why some patients stop OFS therapy and how treatment duration affects breast cancer recurrence, leading to better support strategies.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient differences and real-world factors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female breast cancer patients who were premenopausal at the time of surgery. 2. Newly diagnosed patients with invasive breast cancer, tumor node metastasis(TNM) stage I-III. 3. HR-positive (defined as ER ≥ 10% and/or progesterone receptor(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. Eastern Cooperative Oncology Group Performance Status(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. Exclusion Criteria: 1. Simultaneously participating in another blinded clinical study. 2. Presence of other active malignant tumors or multiple primary cancers. 3. Pregnant or lactating women. 4. Other conditions that the investigator deems unsuitable for inclusion in the study. 5. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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