Breast Cancer Trial, Recruiting NCT04345081 Sponsor: National Institute of Oncology, Hungary Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT04345081
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 the age of 65 who have been diagnosed with primary breast cancer (in one or both breasts) at an early to locally advanced stage (Stage 0 to III), or who need surgery to reduce their risk of breast cancer, and who are planned to have a skin-sparing or nipple-sparing mastectomy followed by immediate or delayed breast reconstruction using an implant.

Who may not be able to join:

  • People who do not wish to take part in the examinations or follow-up appointments required by the trial
  • People aged 65 or over, or those whose general health is poor enough that life expectancy is estimated to be less than 2 years, even without cancer
  • People who have had a previous cancer diagnosis (other than certain common skin cancers)
  • People whose mastectomy and reconstruction are needed because of a breast cancer diagnosed during 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 was not fully removed, as confirmed by laboratory examination of the tissue
  • People who have had a serious non-surgical complication (such as a reaction to radiotherapy) that could affect the appearance or function of the reconstructed breast
  • People with an autoimmune disease
  • People with a form of breast cancer that spreads across the skin of the breast (sometimes called inflammatory or carcinomatosa) (confirm with trial site)
  • People with cancer that has spread into the lymph vessels of the breast (confirm with trial site)
  • People currently being treated for a wound infection from a previous surgery
  • People who have used steroid medication long-term in a way that has changed the quality or structure of their skin
  • People who are under legal guardianship or who are assessed as unable to cooperate with the trial process

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 9 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
18 April 2020
Est. completion
5 April 2022

Where this trial is recruiting

🇭🇺 Hungary

Primary endpoints

Oncological safety; Patients' satisfaction; Cosmetic results; Quality of life

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: 9 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