Breast Cancer Trial, Recruiting NCT04356235 Sponsor: National Institute of Oncology, Hungary Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT04356235
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People under 65 years old who have been diagnosed with primary breast cancer (early to locally advanced stage, including non-invasive) in one or both breasts, and who need a mastectomy that preserves the skin, nipple, or areola, followed by immediate or staged breast reconstruction using an implant on the affected side, and a balancing procedure on the other breast (such as a breast lift, implant, or mesh sling)
  • People under 65 years old who are having a straightforward mastectomy on one side with no breast reconstruction (this group serves as a comparison group in the trial)

Who may not be able to join:

  • People who do not wish to take part in the examinations or follow-up appointments
  • People aged 65 or over, or those in poor general health where life expectancy is estimated to be less than 2 years even without the cancer diagnosis
  • People who have had a different invasive cancer in the past (skin cancers that are not melanoma are excepted)
  • People whose breast cancer is linked to pregnancy
  • People who have had previous breast surgery (such as cosmetic surgery or a breast lift) or radiation treatment to the breast or underarm area
  • People whose cancer has not been fully removed as confirmed by laboratory analysis of the removed tissue
  • People who have had a serious non-surgical complication (such as from radiation therapy) that could affect the appearance or function of the breast
  • People with autoimmune diseases
  • People whose cancer has spread in a way that involves widespread skin involvement (confirm with trial site)
  • People whose cancer has spread into the lymph vessels of the skin (confirm with trial site)
  • People who have an open wound due to a surgical site infection
  • People who have used steroid medications long-term in a way that has affected the skin's quality and structure
  • People who are under guardianship or who are unable to cooperate with the study requirements
  • People who undergo a breast correction procedure during the 5-year follow-up period

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
National Institute of Oncology, Hungary
Registry
ClinicalTrials.gov
Start date
27 April 2020
Est. completion
10 April 2022

Where this trial is recruiting

🇭🇺 Hungary

Primary endpoints

Quality of life: BREAST-Q validated questionnaire; Patient satisfaction: BREAST-Q validated questionnaire

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov