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A real-world study on the compliance of OFS-assisted endocrine therapy for HR+ premenopausal breast cancer

A real-world study on the compliance of OFS-assisted endocrine therapy for HR+ premenopausal breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108901
Enrollment
Unknown
Registered
2025-09-09
Start date
2025-09-09
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Early HR-positive premenopausal breast cancer patients observation group:None

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female breast cancer patients who have not yet reached menopause during surgery; 2. Newly diagnosed patients with invasive breast cancer at TNM stage I-III; 3. HR positive (defined as ER >= 10% and/or PR >= 10%); 4. Have undergone radical breast cancer surgery and plan to receive OFS treatment; 5. Have received (neo)adjuvant chemotherapy and radiotherapy; 6. ECOG PS 0-1; 7. Complete case records; 8. Willing to accept long-term follow-up; 9. Adverse events occurring during adjuvant chemotherapy (if any) have resolved or decreased to grade 1 (according to CTCAE v5.0) at the start of OFS treatment.

Exclusion criteria

Exclusion criteria: 1. Participating simultaneously in another blinded clinical trial; 2. Presence of other active malignant tumors or multiple primary cancers; 3. Pregnant or breastfeeding women; 4. Situations deemed inappropriate for inclusion in the study by the investigator; 5. Planning to use systemic treatment outside of the study protocol description during the endocrine therapy phase (e.g., but not limited to chemotherapy, ADC, or immunotherapy, etc.).

Design outcomes

Primary

MeasureTime frame
OFS discontinuation rate;

Secondary

MeasureTime frame
Survival period of non-invasive diseases;Time to deterioration, TTD;

Countries

China

Contacts

Public ContactYu Yang

Zhejiang Cancer Hospital

yuyangkaiyu@163.com+86 571 8812 2002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026