Clinical trial · Observational
Local and Regional Radiotherapy for Nipple Sparing Mastectomy With Implant
Prospective Observational Study for Local Radiotherapy in Breast Cancer Patients Receiving Nipple Sparing Mastectomy With Breast Reconstruction
- 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)
The prospective observational study of radiation therapy is conducted on the nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node) with a high risk of local recurrence in nipple-sparing mastectomy with reconstruction, we're going to analysis the effects of radiation therapy and cosmetic effects. By evaluating survival rate, recurrence pattern(local lymph node and metastasis to the whole body), side effects, cosmetic effects, from the patients who have gone through Nipple Sparing Mastectomy with reconstruction.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- freedom from local and regioanl recurrence rate : FFLRR rate
- timeFrame
- up to 5 years
- description
- evaluate the freedom from local and regioanl recurrence rate in nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node)
Secondary outcomes (2)
- measure
- relapse-free or overall survivor : RFS and OS
- timeFrame
- up to 5 years
- description
- evaluate the Relapse-free or overall survivor in nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node)
- measure
- toxicity and contraction of the implant, quality of life
- timeFrame
- up to 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. patient who have pathologic confirmation of Ductal carcinoma in situ or invasive caricinoma 2. patient who undergone nipple sparing mastectomy with construction 3. patient who considered radiotherapy in breast cancer at stage IIB or lower (exclude ≥T3, ≥N2) 4. patient who have not distant metastasis 5. age \>19 years old 6. patinet who have an ECOG of 0-2 7. patient who have not comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis) 8. patient who have not prior radiotherapy history in treatment site 9. patient who have not pregnancy or lacting 10. patient who have consent in writing to participate in research Exclusion Criteria: 1. patient who undergone construction after nipple sparing mastectomy 2. patient who have ≥T3, ≥N2 in breast cancer 3. patient who have diastant metastasis 4. patient who have comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis) 5. patient who have treatment history in treatment site 6. patinet who have an ECOG 3-4 7. age \< 20years old 8. patient who have pregnancy or lacting 9. patient who have not consent in writing to participate in research
References
Publications (0)
Data not yet available