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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Cancer

Detailed Description

For the last 20years, Breast Conservation Surgery and postoperative radiotherapy were the well established standard treatment, proven by various clinical trial studies, About 20-50% of breast cancer patients with large tumors, small breasts, or multiple tumors were still considered for Radical mastectomy.

In this case, Nipple Areola Complex (NAC) removal, significantly increases the amputation sensation of the patient and reduces breast contour, cosmetic satisfaction, physical balance, and psychological burden.

For this reason, recently, Nipple Sparing Mastectomy with reconstruction, which does not reduce treatment effect and maintain breast contour function is more considered.

It is reported that from Radical mastectomy specimens, possible tumor cell invasion in Nipple-Areola Complex is about 20%(0-58%).

local recurrence of breast cancer patient for nipple sparing mastectomy is reported to be about 0-28.4%.

Also, while operating a conserved Nipple Areola Complex (NAC) specimen, the false-negative rate of frozen section examination is 1.5-9.3%.

Therefore, due to the limitations of these pathological examinations, the possibility of residual tumor cells in the Nipple-Areola Complex cannot be excluded because that is unidentified and preserved in the tumor cell of the surgical specimen.

Since radiotherapy has been proven to help reduce local recurrence and improve survival rate as postoperative adjuvant treatment in patients who have undergone Breast-Conserving Surgery, a study in Nipple-Sparing Mastectomy also has been conducted to reduce local recurrence.

Benediksson's research team have reported, radiotherapy reduced the local recurrence rate in patients who had undergone Nipple-Sparing Mastectomy with reconstruction.

Petit's research team reported, the local recurrence rate is 1.7% and there was no recurrence near Nipple-Areola Complex in patients who received Nipple-Sparing Mastectomy.

Among the 486 patients who have undergone Nipple-Sparing Mastectomy with reconstruction from January 2012 to December 2017 in National Cancer Center in Korea, the local recurrence rate is 8.2%, 5% of the nipple-areola complex, 2.2% of axillary lymph node, 0.9% of the chest wall. And most of the local recurrence sites were nipple-areola complex and axillary lymph node.

Despite reducing recurrence rate, as an influencing factor to postoperative complications and cosmetics, radiotherapy has a risk of side effects from the Nipple-Sparing Mastectomy with reconstruction-operated patients.

Therefore, by conducting a prospective observational study of radiation therapy to 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.

• Study Type: Observational
• Enrollment (Anticipated): 128

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Goyang, Gyeonggi, Korea, Republic of, 410-769
      • National Cancer Center Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Breast cancer patients receiving nipple sparing mastectomy with breast reconstruction

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
freedom from local and regioanl recurrence rate : FFLRR rate	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)	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relapse-free or overall survivor : RFS and OS	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)	up to 5 years
toxicity and contraction of the implant, quality of life	evaluate the toxicity about breast site, implant surgical complication and contraction, hematopoietic. The quality of life is evaluated with the questionnaire filled out by the study subjects.	up to 5 years

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: Tae Hyun Kim, Ph.D, National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NCC2021-0335

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No