Clinical trial · Observational
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With Hormone Receptor-positive Intraductal Carcinoma of the Breast: A Multicenter, Retrospective, Real-world Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will investigate the relationship between the endocrine therapy and the survival of patients with hormone receptor positive intraductal carcinoma of the breast, and the optimal duration of medication. This study will also analyze the risk factors of recurrence and metastasis of hormone receptor positive intraductal carcinoma of the breast and establish a prognosis model to further clarify the specific reasons for recurrence and metastasis, adverse reactions, and drug withdrawal in patients with hormone receptor positive intraductal carcinoma of the breast after endocrine therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
| Toremifene | Drug | Toremifene | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Drug Group
- description
- Endocrine therapy drugs include selective estrogen receptor modulators (Tamoxifen, Toremifene) and aromatase inhibitors (Anastrozole, Letrozole, Exemestane), which have been widely used in the adjuvant treatment of hormone receptor positive breast cancer.
- interventionNames
- Drug: Tamoxifen
- Drug: Toremifene
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
Primary outcomes (3)
- measure
- Disease-free survival up to 16 years
- timeFrame
- Time from the first disease-free day to the end of the last follow-up, assessed up to 16 years
- description
- Disease-free survival refers to the time from the first disease-free day (i.e. the operation day) to the day at which relevant event occurs.
- measure
- Invasive disease-free survival up to 16 years
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * (1)Female patients aged ≥ 18 years and ≤ 85 years * (2)The primary lesions and lymph nodes of the breast must meet all of the following conditions: 1. Histologically confirmed intraductal carcinoma of the breast, accompanied by microinvasion, with the infiltration range ≤ 1 mm; 2. Have received radical resection or breast conserving surgery; 3. Patients who have received breast conserving surgery must undergo pathological examination to confirm there is no residual cancer tissue on the cutting edge and receive postoperative radiotherapy within the prescribed dose and range; 4. No lymph node metastasis (including micrometastasis) is detected by postoperative pathological examination; 5. Immuno 6. Immunohistochemical staining results are positive for estrogen receptor (ER) or progesterone receptor (PR), which is defined as ER or PR immunoreactivity intensity ≥1+ or expression percentage ≥ 1%. * (3)A volunteer to participate in the study and willing to cooperate with follow-up Exclusion Criteria: * (1)Patients with newly diagnosed metastatic breast cancer or other malignant tumors without breast intraductal carcinoma; * (2) Patients who have other malignant tumors before the initial diagnosis of intraductal carcinoma of the breast * (3) Patients who have received endocrine therapy with drugs including Toremifene, Tamoxifen, Anastrozole, Letrozole or Exemestane before the initial diagnosis of intraductal carcinoma of the breast * (4) Patients who have a serious comorbidity or other comorbidities that interfere with the conduct of the study, or those who are considered not suitable for participation in this study
References
Publications (0)
Data not yet available