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This study aims to evaluate the 5-year invasive ipsilateral breast cancer incidence rate in patients with hormone-receptor positive, HER-2 negative atypical ductal hyperplasia or in-situ carcimona who omitted surgery and received endocrine therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active monitoring arm | Experimental | Active monitoring with endocrine therapy in hormone-receptor positive, HER-2 negative DCIS, LCIS, ADH without surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avoiding surgery | Procedure | Avoiding surgery in hormone-receptor positive atypical ductal hyperplasia and in-situ carcinoma treated with endocrine treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5 year ipsilateral breast cancer incidence rate | This study aims to evaluate the 5-year invasive ipsilateral breast cancer incidence rate in patients with hormone-receptor positive, HER-2 negative atypical ductal hyperplasia or in-situ carcimona who omitted surgery and received endocrine therapy. | 5 years after the last patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Adjuvant chemotherapy rate | 5 year adjuvant chemotherapy rate | 5 years after the last patient enrollment |
| invasive CBC rate | 5 year invasive contralateral breast cancer rate |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic differences in invasive breast cancer progression according to age and type of endocrine therapy | Invasive breast cancer progression will be evaluated according to age at diagnosis and type of endocrine therapy. The proportion of participants who develop histologically confirmed invasive breast cancer during follow-up will be compared across subgroups defined by age and endocrine therapy regimen (tamoxifen, aromatase inhibitor, or combination with ovarian function suppression). |
1. Inclusion criteria:
2. Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeong Eon Lee, MD, PhD | Contact | +82-10-9933-0260 | paojlus@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Jeong Eon Lee, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 5 years after the last patient enrollment |
| OS | 5 year overall survival | 5 years after the last patient enrollment |
| BCSS | 5 year breast cancer specific survival | 5 years after the last patient enrollment |
| Change in health-related quality of life assessed by EORTC QLQ-C30 | HRQoL will be evaluated using the EORTC QLQ-C30. Scores range from 0-100. Higher functional/global health scores indicate better QoL, while higher symptom scores indicate greater symptom burden. | At baseline, at 2 years, and at 5 years after the last patient enrollment |
| Change in breast cancer-specific quality of life assessed by EORTC QLQ-BR23 | Breast cancer-specific QoL will be assessed using the EORTC QLQ-BR23. Scores range from 0-100. Higher functional scores indicate better QoL; higher symptom scores indicate worse symptom burden. | At baseline, at 2 years, and at 5 years after the last patient enrollment |
| 5 years after the last patient enrollment |
| Adverse events associated with endocrine therapy and ovarian function suppression | Incidence and severity of adverse events related to endocrine therapy and/or ovarian function suppression, graded according to CTCAE criteria. | From initiation of endocrine therapy to treatment discontinuation or last follow-up (up to 5 years after enrollment) |
| Direct medical cost of active monitoring compared with standard therapy | Mean total direct medical cost (USD) incurred during 5-year follow-up will be compared between the active monitoring protocol and standard surgical management based on institutional billing data. | 5 years after the last patient enrollment |
| Incremental cost-effectiveness ratio (ICER) of active monitoring compared with standard therapy | Cost-effectiveness will be evaluated by the incremental cost-effectiveness ratio (ICER), calculated as cost per quality-adjusted life-year (QALY) gained for active monitoring versus standard therapy. | 5 years after last patient enrollment. |
| Change in circulating tumor DNA (ctDNA) detectability from baseline to surgery among participants who undergo surgery for invasive progression | Paired assessment of ctDNA detectability (present/absent) at baseline (diagnosis) and at the time of surgery among participants who progress to invasive breast cancer. Peripheral blood (20 mL) is collected at both time points. | Baseline and at time of surgery |
| Longitudinal detectability of circulating tumor DNA (ctDNA) at annual follow-up compared with baseline | Assessment of ctDNA detectability (present/absent) at baseline and at annual follow-up visits in all enrolled participants. Peripheral blood (20 mL) is collected at each time point. | Baseline (Day 1) and annually through study completion (up to 5 years) |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |