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NCT04517266

Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer

Recruiting now NA Last updated 4 December 2023
What this trial tests

NA trial testing omit of IMI group in Breast Cancer in 214 participants. Currently enrolling.

Timeline
1 March 2021
Primary endpoint
30 October 2025
30 October 2030

Quick facts

Lead sponsorRuijin Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment214
Start date1 March 2021
Primary completion30 October 2025
Estimated completion30 October 2030
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Ruijin Hospital

Who can join

Adults 18 to 80, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The effect of internal mammary irradiation (IMI) added to whole-breast or thoracic-wall irradiation plus supraclavicular (SVC) irradiation after surgery on survival among women with early-stage intermediate risk (N1) breast cancer remains debated. The present study aimed to identified patient could be omitted from internal mammary lymph node irradiation by using a clinical-genomic model.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Long-Term Effects of Breast Cancer Therapy and Care: Calm after the Storm?
    Tommasi C, Balsano R, Corianò M, Pellegrino B, et al · · 2022 · cited 36× · PMID 36498813 · DOI 10.3390/jcm11237239
  2. IMNI PRECISION trial protocol: a phase II, open-label, non-inferior randomized controlled trial of tailoring omission of internal mammary node irradiation for early-stage breast cancer.
    Qi WX, Cao L, Zheng S, Xu C, et al · · 2022 · cited 5× · PMID 36575421 · DOI 10.1186/s12885-022-10454-1
  3. Navigating precision: the crucial role of next-generation sequencing recurrence risk assessment in tailoring adjuvant therapy for hormone receptor-positive, human epidermal growth factor Receptor2-negative early breast cancer.
    Xu Y, Qi Y, Lu Z, Tan Y, et al · · 2024 · cited 3× · PMID 39304993 · DOI 10.1080/15384047.2024.2405060
  4. The optimal regional irradiation volume for breast cancer patients: A comprehensive systematic review and network meta-analysis of published studies.
    Qi WX, Cao L, Xu C, Cai G, et al · · 2023 · PMID 36798812 · DOI 10.3389/fonc.2023.1081201

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Ruijin Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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