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Enrolling by invitation Observational

Local and Regional Radiotherapy for Nipple Sparing Mastectomy With Implant

NCT05213962 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2021-11-15
Last updated
2022-01-28

Condition(s) studied

Breast Cancer

Study summary

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.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • freedom from local and regioanl recurrence rate : FFLRR rate — up to 5 years
    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)

Trial sites (1)

FacilityCityRegionStatus
National Cancer Center Korea Goyang-si Gyeonggi-do
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05213962 on ClinicalTrials.gov ↗ ← All trials in South Korea