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Breast CancerNCT03273348

Role of Oncoplastic Breast Surgery In Breast Cancer Treatement

A study testing Oncoplastic breast surgery in people with Breast Cancer, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Role of Oncoplastic Breast Surgery In Breast Cancer Treatement Read more about this study

Who is it for?
Ages 30 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Oncoplastic breast surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
28 Sep 2017to 28 Oct 2019
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 30 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The study will include 30 women with early-stage breast cancer treated at general surgery department, Assuit University Hospitals
  • For all patients an informed consent for their inclusion in the study including the use of images will be obtained.
  • Selection criteria include women with a pre-operative diagnosis (clinical examination, imaging and needle biopsy) of Tis, T1 and T2 tumours without extensive skin involvement.

Who cannot join

  • • contraindaction for general anesthesia
  • Positive margin requiring mastectomy
  • Insufficient remaining breast volume
  • Diffuse microcalcifications
  • Multicentric tumor?
  • Inflammatory breast cancer
  • Previous radiotherapy
  • Concomitant disease ( Diabetes, smoking )

Trial locations and contacts

1 site in 1 country.

Alaa mohammed sebaiy, MSc contact

01142950929

ams_2100@yahoo.com

faculty of medicine assiut university contact

Egypt1 site
  • Assiut University

    Asyut

Other trials in Egypt

About this study

Role of Oncoplastic Breast Surgery In Breast Cancer Treatement

Read the detailed description

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)

Conditions
Breast Cancer
Being tested
Oncoplastic breast surgery
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oncoplastic breast surgeryProcedure or surgery

    Also called breast reconstruction

    , 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

Study groups in NCT03273348
Study groupRoleWhat they receive
oncoplastic breast surgeryOtherThis 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 .
Receives: Procedure: Oncoplastic breast surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. oncological safety

    the pathological report postoperative reveals safety free margins

    Measured: for 2 weaks

Secondary outcomes (3)
  1. postoperative recurrence of malignany

    follow up any malignancy recurrence post operative by MRI , Mammograghy and look for any new skin nodule appearance

    Measured: assess for 1 year postoperative

  2. mortality rate

    number of deaths intraoperative and postoperative related to surgery

    Measured: up to 3 months postoperative for each case

  3. post operative skin edge ischemia

    look for any postoperative ischemia appear in the skin flap as appearance of dark unhealthy tissue in the edge

    Measured: assess for 1 month postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2017
  2. Study start28 Sep 2017 (estimated)
  3. Primary completion28 Sep 2019 (estimated)
  4. Study completion28 Oct 2019 (estimated)

Resources

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
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.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03273348
Sponsor's protocol ID
17200114
Status last verified
Sep 2017
First submitted
25 Aug 2017
Last updated
6 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: postoperative imaging such as mammogram, ultrasound and MRI studies

Publications

  • 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.

    PubMed 21351269
  • 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.

    PubMed 20195109
  • 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.

    PubMed 23503430

Questions about this trial

What is this clinical trial studying?

A study testing Oncoplastic breast surgery in people with Breast Cancer, 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 3 inclusion and 8 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 6 Sep 2017. 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 Alaa mohammed sebaiy, MSc (01142950929, ams_2100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

oncological safety (time frame: for 2 weaks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03273348, which also lists 3 linked publications.

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 6 Sep 2017.

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