Breast CancerNCT05213962
Local and Regional Radiotherapy for Nipple Sparing Mastectomy With Implant
An observational study of Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2021to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients receiving nipple sparing mastectomy with breast reconstruction
Who may be able to join
- patient who have pathologic confirmation of Ductal carcinoma in situ or invasive caricinoma
- patient who undergone nipple sparing mastectomy with construction
- patient who considered radiotherapy in breast cancer at stage IIB or lower (exclude ≥T3, ≥N2)
- patient who have not distant metastasis
- age >19 years old
- patinet who have an ECOG of 0-2
Show all 10Show fewer
- patient who have not comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis)
- patient who have not prior radiotherapy history in treatment site
- patient who have not pregnancy or lacting
- patient who have consent in writing to participate in research
Who cannot join
- patient who undergone construction after nipple sparing mastectomy
- patient who have ≥T3, ≥N2 in breast cancer
- patient who have diastant metastasis
- patient who have comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis)
- patient who have treatment history in treatment site
- patinet who have an ECOG 3-4
Show all 9Show fewer
- age < 20years old
- patient who have pregnancy or lacting
- patient who have not consent in writing to participate in research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 5 years
Secondary outcomes (2)
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)
Measured: 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.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start15 Nov 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tae Hyun Kim, National Cancer Center, Korea
- Investigators
- Tae hyun Kim, Ph.D, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213962
- Sponsor's protocol ID
- NCC2021-0335
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for Local Radiotherapy in Breast Cancer Patients Receiving Nipple Sparing Mastectomy With Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05213962
- Acronym / sponsor ID
- NCC2021-0335
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients receiving nipple sparing mastectomy with breast reconstruction
Key inclusion criteria (10 listed)
- patient who have pathologic confirmation of Ductal carcinoma in situ or invasive caricinoma
- patient who undergone nipple sparing mastectomy with construction
- patient who considered radiotherapy in breast cancer at stage IIB or lower (exclude ≥T3, ≥N2)
- patient who have not distant metastasis
- age >19 years old
Key exclusion criteria (9 listed)
- patient who undergone construction after nipple sparing mastectomy
- patient who have ≥T3, ≥N2 in breast cancer
- patient who have diastant metastasis
- patient who have comorbidities(collagne vascular disease, such as systemic lupus erythermatosis, scleroderma, dermatomyositis)
- patient who have treatment history in treatment site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
freedom from local and regioanl recurrence rate : FFLRR rate
Time frame: 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)
2 secondary outcomes
relapse-free or overall survivor : RFS and OS
Time frame: up to 5 years
toxicity and contraction of the implant, quality of life
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tae hyun Kim, Ph.D principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
freedom from local and regioanl recurrence rate : FFLRR rate (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.