<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03273348</url>
  </required_header>
  <id_info>
    <org_study_id>17200114</org_study_id>
    <nct_id>NCT03273348</nct_id>
  </id_info>
  <brief_title>Role of Oncoplastic Breast Surgery In Breast Cancer Treatement</brief_title>
  <official_title>Role of Oncoplastic Breast Surgery In Breast Cancer Treatement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Role of Oncoplastic Breast Surgery In Breast Cancer Treatement&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer is the most common cancer in women throughout the world (FerlayJ.,2010) .&#xD;
&#xD;
      The overarching principle guiding surgical management of women with breast cancer remains the&#xD;
      oncological safety. The mainstay of satisfactory local control continues to be adequate&#xD;
      clearance of the primary tumour and involved axillary lymph nodes. Improvements in&#xD;
      understanding of tumour biology have enabled the risk of loco-regional recurrence and distant&#xD;
      events to be further reduced by adjuvant, or neo-adjuvant, radiotherapy and systemic&#xD;
      treatments. In keeping with this, breast conserving therapy has become well established as&#xD;
      the treatment of choice for most women with early breast cancer . However, approximately&#xD;
      one-third of women still undergo mastectomy, either due to patient preference or in cases&#xD;
      where breast conservation is not oncologically or aesthetically compatible with the size or&#xD;
      distribution of disease. (Reefy et al; 2010)&#xD;
&#xD;
      The primary aim of BCS is preservation of the breast while adhering to oncologic principles,&#xD;
      with the secondary objective to provide breast aesthetics. In recent years, with advances in&#xD;
      early detection and adjuvant therapy life expectancy has prolonged in breast cancer prolonged&#xD;
      and quality of life issues have gained importance (Veiga DF.,2010)&#xD;
&#xD;
      Skin sparing mastectomy involves the en-bloc removal of all glandular tissue including the&#xD;
      nipple-areola complex and in some cases adjacent biopsy scars and skin overlying superficial&#xD;
      tumours. In contrast to conventional mastectomy, there is maximal preservation of the&#xD;
      remaining breast skin envelope and infra-mammary fold that facilitate immediate breast&#xD;
      reconstruction with autologous tissue and/or prosthetic implants by utilising the native skin&#xD;
      envelope to optimise the contour, texture, colour and scarring of the reconstructed breast.&#xD;
      (Cunnick and Mokbel; 2004).&#xD;
&#xD;
      Due to the positive results obtained in the surgical treatment of breast cancer, the&#xD;
      prevalence of this technique is increasing throughout the world and our country. There was an&#xD;
      approximately 2.3-fold increase in OBS publications over the last five years (Losken A et&#xD;
      al.,2014)&#xD;
&#xD;
      Surgical planning and timing of reconstruction should include breast volume, tumor location,&#xD;
      the extent of glandular tissue resected, enabling each patient to receive an individual&#xD;
      &quot;custom-made&quot; reconstruction. With immediate oncoplastic approach, the surgical process is&#xD;
      smooth since oncological and reconstructive surgery can be associated in one operative&#xD;
      setting. Additionally, because there is no scar and fibrosis tissue, breast reshaping is&#xD;
      easier, and the aesthetic is improved (Munhoz AM et al .,2011) When considering a patient for&#xD;
      an oncoplastic breast conserving procedure, the following points must be considered:&#xD;
&#xD;
        1. volume of tissue to be excised;&#xD;
&#xD;
        2. tumour location;&#xD;
&#xD;
        3. breast size and glandular density;&#xD;
&#xD;
        4. patient related risk factors, particularly smoking, obesity, diabetes, previous surgery;&#xD;
&#xD;
        5. adjuvant therapies. Excision volume is the single, most predictive factor for breast&#xD;
           deformity (Clough KB et al .,2010).&#xD;
&#xD;
      Recently, several studies have contributed to the evidence base supporting the oncological&#xD;
      adequacy of skin sparing mastectomy in selected early-stage breast cancer , excluding&#xD;
      inflammatory breast cancer and tumours with extensive involvement of the skin. In this study&#xD;
      the oncological safety, post-operative morbidity and patients' satisfaction with skin sparing&#xD;
      mastectomy and immediate breast reconstruction will be evaluated in a prospective cohort of&#xD;
      women with early-stage breast cancer. (Cunnick and Mokbel; 2004) Skin sparing mastectomy and&#xD;
      immediate breast reconstruction is particularly attractive for women with ductal Carcinoma&#xD;
      In-Situ in view of the fact that post-mastectomy radiotherapy is not given to the&#xD;
      reconstructed breast and the risk of loco-regional recurrence is very low. (Spiegel and&#xD;
      Butler; 2003)&#xD;
&#xD;
      Most women who will undergo skin sparing mastectomy and immediate breast reconstruction for&#xD;
      early-stage breast cancer will not require post-mastectomy radiotherapy. However,&#xD;
      post-mastectomy radiotherapy has been shown to reduce loco-regional recurrence and improve&#xD;
      survival for patients with three or more involved regional lymph nodes or tumors &gt;5 cm.&#xD;
      (Recht and Edge; 2003) Mastectomy can also be indicated in several non-invasive conditions.&#xD;
      Ductal Carcinoma In-Situ may necessitate mastectomy when the lesions are extensive,&#xD;
      multi-centric or recurrent, however, patients request to be managed in this way. Mastectomy&#xD;
      for ductal Carcinoma In-Situ is associated with cure rates in excess of 98%. (Mokbel; 2003)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 28, 2017</start_date>
  <completion_date type="Anticipated">October 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study aim to evaluate the outcome on oncological side and patient satisfaction on the aesthetic side with skin-sparing mastectomy and immediate breast reconstruction for patients with early breast cancer .&#xD;
.&#xD;
The obtained results may contribute to the formulation of guidelines achieving low morbidity, high levels of patient satisfaction and oncological safety in breast cancer patients.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>oncological safety</measure>
    <time_frame>for 2 weaks</time_frame>
    <description>the pathological report postoperative reveals safety free margins</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative recurrence of malignany</measure>
    <time_frame>assess for 1 year postoperative</time_frame>
    <description>follow up any malignancy recurrence post operative by MRI , Mammograghy and look for any new skin nodule appearance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality rate</measure>
    <time_frame>up to 3 months postoperative for each case</time_frame>
    <description>number of deaths intraoperative and postoperative related to surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post operative skin edge ischemia</measure>
    <time_frame>assess for 1 month postoperative</time_frame>
    <description>look for any postoperative ischemia appear in the skin flap as appearance of dark unhealthy tissue in the edge</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>oncoplastic breast surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This study aim to evaluate the outcome on oncological side and patient satisfaction on the aesthetic side with skin-sparing mastectomy and immediate breast reconstruction for patients with early breast cancer .</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oncoplastic breast surgery</intervention_name>
    <description>, Skin sparing mastectomy and immediate breast reconstruction will be conducted to all women included in the study, transverse rectus abdominis musculocutaneous flap recostruction and latissimus dorsi myocutaneous pedicle-flap with and without implant</description>
    <arm_group_label>oncoplastic breast surgery</arm_group_label>
    <other_name>breast reconstruction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study will include 30 women with early-stage breast cancer treated at general&#xD;
             surgery department, Assuit University Hospitals&#xD;
&#xD;
          -  For all patients an informed consent for their inclusion in the study including the&#xD;
             use of images will be obtained.&#xD;
&#xD;
          -  Selection criteria include women with a pre-operative diagnosis (clinical examination,&#xD;
             imaging and needle biopsy) of Tis, T1 and T2 tumours without extensive skin&#xD;
             involvement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • contraindaction for general anesthesia&#xD;
&#xD;
               -  Positive margin requiring mastectomy&#xD;
&#xD;
               -  Insufficient remaining breast volume&#xD;
&#xD;
               -  Diffuse microcalcifications&#xD;
&#xD;
               -  Multicentric tumor?&#xD;
&#xD;
               -  Inflammatory breast cancer&#xD;
&#xD;
               -  Previous radiotherapy&#xD;
&#xD;
               -  Concomitant disease ( Diabetes, smoking )&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alaa mohammed sebaiy, MSc</last_name>
    <phone>01142950929</phone>
    <email>ams_2100@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>faculty of medicine assiut university</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.</citation>
    <PMID>21351269</PMID>
  </reference>
  <reference>
    <citation>Veiga DF, Veiga-Filho J, Ribeiro LM, Archangelo I Jr, Balbino PF, Caetano LV, Novo NF, Ferreira LM. Quality-of-life and self-esteem outcomes after oncoplastic breast-conserving surgery. Plast Reconstr Surg. 2010 Mar;125(3):811-7. doi: 10.1097/PRS.0b013e3181ccdac5.</citation>
    <PMID>20195109</PMID>
  </reference>
  <reference>
    <citation>Losken A, Dugal CS, Styblo TM, Carlson GW. A meta-analysis comparing breast conservation therapy alone to the oncoplastic technique. Ann Plast Surg. 2014 Feb;72(2):145-9. doi: 10.1097/SAP.0b013e3182605598.</citation>
    <PMID>23503430</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 2, 2017</last_update_submitted>
  <last_update_submitted_qc>September 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Alaa Mohammed Sebaiy</investigator_full_name>
    <investigator_title>general surgery specialist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>postoperative imaging such as mammogram, ultrasound and MRI studies</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03273348
org study id: 17200114
nct id: NCT03273348
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Role of Oncoplastic Breast Surgery In Breast Cancer Treatement
Breast cancer is the most common cancer in women throughout the world (FerlayJ.,2010) .

      The overarching principle guiding surgical management of women with breast cancer remains the
      oncological safety. The mainstay of satisfactory local control continues to be adequate
      clearance of the primary tumour and involved axillary lymph nodes. Improvements in
      understanding of tumour biology have enabled the risk of loco-regional recurrence and distant
      events to be further reduced by adjuvant, or neo-adjuvant, radiotherapy and systemic
      treatments. In keeping with this, breast conserving therapy has become well established as
      the treatment of choice for most women with early breast cancer . However, approximately
      one-third of women still undergo mastectomy, either due to patient preference or in cases
      where breast conservation is not oncologically or aesthetically compatible with the size or
      distribution of disease. (Reefy et al; 2010)

      The primary aim of BCS is preservation of the breast while adhering to oncologic principles,
      with the secondary objective to provide breast aesthetics. In recent years, with advances in
      early detection and adjuvant therapy life expectancy has prolonged in breast cancer prolonged
      and quality of life issues have gained importance (Veiga DF.,2010)

      Skin sparing mastectomy involves the en-bloc removal of all glandular tissue including the
      nipple-areola complex and in some cases adjacent biopsy scars and skin overlying superficial
      tumours. In contrast to conventional mastectomy, there is maximal preservation of the
      remaining breast skin envelope and infra-mammary fold that facilitate immediate breast
      reconstruction with autologous tissue and/or prosthetic implants by utilising the native skin
      envelope to optimise the contour, texture, colour and scarring of the reconstructed breast.
      (Cunnick and Mokbel; 2004).

      Due to the positive results obtained in the surgical treatment of breast cancer, the
      prevalence of this technique is increasing throughout the world and our country. There was an
      approximately 2.3-fold increase in OBS publications over the last five years (Losken A et
      al.,2014)

      Surgical planning and timing of reconstruction should include breast volume, tumor location,
      the extent of glandular tissue resected, enabling each patient to receive an individual
      "custom-made" reconstruction. With immediate oncoplastic approach, the surgical process is
      smooth since oncological and reconstructive surgery can be associated in one operative
      setting. Additionally, because there is no scar and fibrosis tissue, breast reshaping is
      easier, and the aesthetic is improved (Munhoz AM et al .,2011) When considering a patient for
      an oncoplastic breast conserving procedure, the following points must be considered:

        1. volume of tissue to be excised;

        2. tumour location;

        3. breast size and glandular density;

        4. patient related risk factors, particularly smoking, obesity, diabetes, previous surgery;

        5. adjuvant therapies. Excision volume is the single, most predictive factor for breast
           deformity (Clough KB et al .,2010).

      Recently, several studies have contributed to the evidence base supporting the oncological
      adequacy of skin sparing mastectomy in selected early-stage breast cancer , excluding
      inflammatory breast cancer and tumours with extensive involvement of the skin. In this study
      the oncological safety, post-operative morbidity and patients' satisfaction with skin sparing
      mastectomy and immediate breast reconstruction will be evaluated in a prospective cohort of
      women with early-stage breast cancer. (Cunnick and Mokbel; 2004) Skin sparing mastectomy and
      immediate breast reconstruction is particularly attractive for women with ductal Carcinoma
      In-Situ in view of the fact that post-mastectomy radiotherapy is not given to the
      reconstructed breast and the risk of loco-regional recurrence is very low. (Spiegel and
      Butler; 2003)

      Most women who will undergo skin sparing mastectomy and immediate breast reconstruction for
      early-stage breast cancer will not require post-mastectomy radiotherapy. However,
      post-mastectomy radiotherapy has been shown to reduce loco-regional recurrence and improve
      survival for patients with three or more involved regional lymph nodes or tumors >5 cm.
      (Recht and Edge; 2003) Mastectomy can also be indicated in several non-invasive conditions.
      Ductal Carcinoma In-Situ may necessitate mastectomy when the lesions are extensive,
      multi-centric or recurrent, however, patients request to be managed in this way. Mastectomy
      for ductal Carcinoma In-Situ is associated with cure rates in excess of 98%. (Mokbel; 2003)
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study aim to evaluate the outcome on oncological side and patient satisfaction on the aesthetic side with skin-sparing mastectomy and immediate breast reconstruction for patients with early breast cancer .
.
The obtained results may contribute to the formulation of guidelines achieving low morbidity, high levels of patient satisfaction and oncological safety in breast cancer patients.
primary purpose: Treatment
masking: None (Open Label)
measure: oncological safety
time frame: for 2 weaks
description: the pathological report postoperative reveals safety free margins
measure: postoperative recurrence of malignany
time frame: assess for 1 year postoperative
description: follow up any malignancy recurrence post operative by MRI , Mammograghy and look for any new skin nodule appearance
measure: mortality rate
time frame: up to 3 months postoperative for each case
description: number of deaths intraoperative and postoperative related to surgery
measure: post operative skin edge ischemia
time frame: assess for 1 month postoperative
description: look for any postoperative ischemia appear in the skin flap as appearance of dark unhealthy tissue in the edge
arm group label: oncoplastic breast surgery
arm group type: Other
description: This study aim to evaluate the outcome on oncological side and patient satisfaction on the aesthetic side with skin-sparing mastectomy and immediate breast reconstruction for patients with early breast cancer .
intervention type: Procedure
intervention name: Oncoplastic breast surgery
description: , Skin sparing mastectomy and immediate breast reconstruction will be conducted to all women included in the study, transverse rectus abdominis musculocutaneous flap recostruction and latissimus dorsi myocutaneous pedicle-flap with and without implant
arm group label: oncoplastic breast surgery
other name: breast reconstruction
criteria: 
gender: Female
gender based: Yes
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alaa mohammed sebaiy, MSc
phone: 01142950929
email: ams_2100@yahoo.com
last name: faculty of medicine assiut university
facility: 
country: Egypt
citation: Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.
PMID: 21351269
citation: Veiga DF, Veiga-Filho J, Ribeiro LM, Archangelo I Jr, Balbino PF, Caetano LV, Novo NF, Ferreira LM. Quality-of-life and self-esteem outcomes after oncoplastic breast-conserving surgery. Plast Reconstr Surg. 2010 Mar;125(3):811-7. doi: 10.1097/PRS.0b013e3181ccdac5.
PMID: 20195109
citation: Losken A, Dugal CS, Styblo TM, Carlson GW. A meta-analysis comparing breast conservation therapy alone to the oncoplastic technique. Ann Plast Surg. 2014 Feb;72(2):145-9. doi: 10.1097/SAP.0b013e3182605598.
PMID: 23503430
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Alaa Mohammed Sebaiy
investigator title: general surgery specialist
mesh term: Breast Neoplasms
sharing ipd: Undecided
ipd description: postoperative imaging such as mammogram, ultrasound and MRI studies