Safety of Excision the New Tumor SizeNCT05115279
Outcomes of Breast Conservative Surgery for Post Chemotherapy Tumour Size After Response to Neoadjuvant Chemotherapy
A study testing breast conservative surgery for post chemotherapy tumour size in people with Safety of Excision the New Tumor Size, run by Assiut University at 1 site in Egypt.
Trial summary
Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers (1). The incidence of breast cancer increases with age (2, 3). Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Safety of Excision the New Tumor Size
- What is being tested?
- breast conservative surgery for post chemotherapy tumour size
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- a. Inclusion criteria:
- Female patients with operable breast cancer
- Female Patient aged from 20 to 60 years old
- Patients who are fit for general anesthesia.
- Patients who provide a written informed consent.
- Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.
Who cannot join
- <!-- -->
- Female patients less than 20 years old
- Stage 4 breast cancer
- Patient has no pathological or clinical response to NACT
- Patients who are contraindicated for radiotherapy
- Pregnant patients in first trimester
- Patient with inflammatory carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Surgical Outcomes of Breast Conservative Surgery for Post Chemotherapy Tumour Size in Patients Had a Favourable Response to Neoadjuvant Chemotherapy
Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers (1). The incidence of breast cancer increases with age (2, 3). Approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage(4) Neoadjuvant chemotherapy (NACT) is considered the standard of care for the management of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease. (5). Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors(6) . Neoadjuvant chemotherapy (NACT) could reduce surgical morbidity of the breast and axilla. By down staging of the tumor, NACT can convert patients who are candidates for mastectomy to breast-conserving surgery (BCS) candidates [7]. Furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for BCS. Another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided (8).
Complete pathological response after neoadjuvant systemic treatment is high, while complete clinical response rates are even higher. Because it is difficult to localize the original tumor bed after a complete clinical and radiological response, marking the tumor before the start of neoadjuvant systemic treatment is required to enable breast-conserving surgery afterward. Achieving adequate margins of excision is an important component of breast surgery. Local recurrence rates are significantly higher for patients who have positive margins of excision (9) some prospective and retrospective data suggested that patients with BCT after neoadjuvant therapy may have an increased risk for the development of a local recurrence .
Read more
If this were true, there would be no further advantage of neoadjuvant therapy and this treatment option could be questioned altogether.
A common question raised with respect to performing breast-conserving therapy after neoadjuvant chemotherapy is the volume of breast tissue that should be resected
Read the detailed description
Study subjects:
- Inclusion criteria:
- Female patients with operable breast cancer
- Female Patient aged from 20 to 60 years old
- Patients who are fit for general anesthesia.
- Patients who provide a written informed consent.
- Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.
- Exclusion criteria:
- Female patients less than 20 years old
- Stage 4 breast cancer
- Patient has no pathological or clinical response to NACT
- Patients who are contraindicated for radiotherapy
- Pregnant patients in first trimester
- Patient with inflammatory carcinoma
- Sample Size Calculation:
Prospective trial study include 50 patient whom fulfilled the inclusion criteria 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): This prospective study is including patients will be diagnosed breast cancer and will receive neoadjuvant chemotherapy .
All patients underwent a preoperative clinical evaluation including physical examination (PE), ultrasonography, mammograph and MRI then biopsies of the breast tumor were performed to determine the histological subtype and receptor status Methods
Pro-operative preparation:
After confirming diagnosis of breast cancer and its molecular type patient undergoing marking the tumor and axillary lymph nodes by clips before receiving neoadjuvant chemotherapy.
Making Virtual pre-operative breast conserving surgical technique based on the previous tumor size
The Surgical steps:
- Depending on new tumor size ,site of the tumor ,breast cup size and degree of breast ptosis ;oncoplastic breast conserving technique would be selected
- A prophylactic antibiotic as first generation cephalosporin is given intravenous.
- Skin preparation by povidine iodine.
- Excision of the mass with safety margin.
- Sentinel axillary lymph node or complete axillary clearance depend on axillary lymph node status
- All specimens were oriented with sutures
- A frozen section examination of the specimen was performed intraoperative
- When the margin status was inadequate, a re-excision was performed
- Closure as drawn by different oncoplastic technique
- Conditions
- Safety of Excision the New Tumor Size
- Being tested
- breast conservative surgery for post chemotherapy tumour size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast conservative surgery for post chemotherapy tumour sizeProcedure or surgery
- Skin preparation by povidine iodine.
- Excision of the mass with safety margin.
- Sentinel axillary lymph node or complete axillary clearance depend on axillary lymph node status
- All specimens were oriented with sutures
- A frozen section examination of the specimen was performed intraoperative
- When the margin status was inadequate, a re-excision was performed
- Closure as drawn by different oncoplastic technique
| Study group | Role | What they receive |
|---|---|---|
| Breast conservative Surgury after neuadjvant chemotherapy | Other | Breast conservative Surgury Receives: Procedure: breast conservative surgery for post chemotherapy tumour size |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast conservative surgery after neoadjuvant chemotherapy
negative inked margin by intraoperative frozen section annual free PET CT scan from recurrence anf metastasis
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of Excision the New Tumor SizeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Type of the study: prospective descriptive study
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samir hosny mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115279
- Sponsor's protocol ID
- assuitu faculty of medicine
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surgical Outcomes of Breast Conservative Surgery for Post Chemotherapy Tumour Size in Patients Had a Favourable Response to Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05115279
- Acronym / sponsor ID
- assuitu faculty of medicine
- Conditions
- Safety of Excision the New Tumor Size
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 10 Nov 2021 (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.
Breast cancer is the most common cancer among women. The morbidity and mortality of breast cancer are much higher than those observed with other female cancers (1). The incidence of breast cancer increases with age (2, 3). Approximately 1.7 million new cases are estimated to occur worldwide, and mortality is increasing in developing countries, primarily because the disease is not diagnosed until it is in an advanced stage(4) Neoadjuvant chemotherapy (NACT) is considered the standard of care for the management of locally advanced breast cancer and although this treatment has historically been reserved for those with inoperable breast cancer now is increasingly being used for women with earlier stage disease. (5). Encouraging results obtained with neoadjuvant chemotherapy in have resulted in clinicians using preoperative chemotherapy for patients with smaller tumors(6) . Neoadjuvant chemotherapy (NACT) could reduce surgical morbidity of the breast and axilla. By down staging of the tumor, NACT can convert patients who are candidates for mastectomy to breast-conserving surgery (BCS) candidates [7]. Furthermore, it has potential to reduce excision volumes in patients with large tumors who are already candidates for BCS. Another surgical advantage is down staging of the axilla so that axillary lymph node dissection can be avoided (8).
Complete pathological response after neoadjuvant systemic treatment is high, while complete clinical response rates are even higher. Because it is difficult to localize the original tumor bed after a complete clinical and radiological response, marking the tumor before the start of neoadjuvant systemic treatment is required to enable breast-conserving surgery afterward. Achieving adequate margins of excision is an important component of breast surgery. Local recurrence rates are significantly higher for patients who have positive margins of excision (9) some prospective and retrospective data suggested that patients with BCT after neoadjuvant therapy may have an increased risk for the development of a local recurrence .
If this were true, there would be no further advantage of neoadjuvant therapy and this treatment option could be questioned altogether.
A common question raised with respect to performing breast-conserving therapy after neoadjuvant chemotherapy is the volume of breast tissue that should be resected
Detailed description
Study subjects:
- Inclusion criteria:
- Female patients with operable breast cancer
- Female Patient aged from 20 to 60 years old
- Patients who are fit for general anesthesia.
- Patients who provide a written informed consent.
- Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information.
- Exclusion criteria:
- Female patients less than 20 years old
- Stage 4 breast cancer
- Patient has no pathological or clinical response to NACT
- Patients who are contraindicated for radiotherapy
- Pregnant patients in first trimester
- Patient with inflammatory carcinoma
- Sample Size Calculation:
Prospective trial study include 50 patient whom fulfilled the inclusion criteria 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): This prospective study is including patients will be diagnosed breast cancer and will receive neoadjuvant chemotherapy .
All patients underwent a preoperative clinical evaluation including physical examination (PE), ultrasonography, mammograph and MRI then biopsies of the breast tumor were performed to determine the histological subtype and receptor status Methods
Pro-operative preparation:
After confirming diagnosis of breast cancer and its molecular type patient undergoing marking the tumor and axillary lymph nodes by clips before receiving neoadjuvant chemotherapy.
Making Virtual pre-operative breast conserving surgical technique based on the previous tumor size
The Surgical steps:
- Depending on new tumor size ,site of the tumor ,breast cup size and degree of breast ptosis ;oncoplastic breast conserving technique would be selected
- A prophylactic antibiotic as first generation cephalosporin is given intravenous.
- Skin preparation by povidine iodine.
- Excision of the mass with safety margin.
- Sentinel axillary lymph node or complete axillary clearance depend on axillary lymph node status
- All specimens were oriented with sutures
- A frozen section examination of the specimen was performed intraoperative
- When the margin status was inadequate, a re-excision was performed
- Closure as drawn by different oncoplastic technique
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Type of the study: prospective descriptive study
| Arm | Type | Receives |
|---|---|---|
| Breast conservative Surgury after neuadjvant chemotherapy | Other | Procedure: breast conservative surgery for post chemotherapy tumour sizeBreast conservative Surgury |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- a. Inclusion criteria:
Key exclusion criteria (7 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breast conservative surgery for post chemotherapy tumour size* Skin preparation by povidine iodine. * Excision of the mass with safety margin. * Sentinel axillary lymph node or complete axillary clearance depend on axillary lymph node status * All specimens were oriented with sutures * A frozen section examination of the specimen was performed intraoperative * When the margin status was inadequate, a re-excision was performed * Closure as drawn by different oncoplastic technique | Procedure or surgery | Breast conservative Surgury after neuadjvant chemotherapy |
Primary outcome
breast conservative surgery after neoadjuvant chemotherapy
Time frame: 4 years
negative inked margin by intraoperative frozen section annual free PET CT scan from recurrence anf metastasis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: Yes
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast conservative surgery for post chemotherapy tumour size in people with Safety of Excision the New Tumor Size, run by Assiut University at 1 site in Egypt.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Nov 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samir Hosny, Master (01095088043, Samir.hosny@aun.edu.eh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast conservative surgery after neoadjuvant chemotherapy (time frame: 4 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 10 Nov 2021.