NCT07593976

Brief Summary

The GATHER trial aim to evaluate the diagnostic performance of \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT in predicting pCR following neoadjuvant chemotherapy. This study is part of the development of new functional, non-invasive approaches with the aim of offering personalized therapeutic approaches.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
18mo left

Started Sep 2026

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Breast Cancer

Keywords

early breast cancerPositron emission tomographyGallium radioisotopespathological complete response

Outcome Measures

Primary Outcomes (1)

  • Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the invasive pathological complete response

    The concordance rate is defined as the proportion of patients correctly classified by the post-therapeutic PET/CT compared to the gold standard histopathological assessment (ypT0/is ypN0).

    2 weeks after surgery

Secondary Outcomes (2)

  • Concordance rate between the response estimated by [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT and the pCR on both invasive and non-invasive components

    two weeks after surgery

  • Comparison of the diagnostic performance of [68Ga]Ga-NOTA-anti-HER2-sdAb PET/CT against other conventional imaging modalities in predicting the invasive pCR

    Two weeks after surgery

Study Arms (1)

[68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography

EXPERIMENTAL

Patients will undergo an \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery

Other: [68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography

Interventions

[68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission TomographyOTHER

Patients will undergo an \[68Ga\]Ga-NOTA-anti-HER2-sdAb PET/CT before neoadjuvant chemotherapy and 15 days prior the scheduled surgery

[68Ga]Ga-NOTA-anti-HER2-sdAb Positron Emission Tomography

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female aged 18 years or older
  • Histologically proven HER2-positive early breast cancer, defined as IHC 3+ or IHC 2+ with ISH amplification
  • Indication for neoadjuvant chemotherapy combined with anti-HER2 targeted therapy followed by surgery, as determined by a multidisciplinary tumor board
  • ECOG performance status of 0 or 1
  • Affiliated to or beneficiary of a social protection scheme
  • Written informed consent signed prior to any study-specific procedure

You may not qualify if:

  • Pregnant or breastfeeding women
  • Patient not treated with curative intent
  • History of ipsilateral breast cancer treated by surgery and/or radiotherapy
  • Lobular histology
  • Known contraindication or hypersensitivity to \[68Ga\]Ga-NOTA-anti-HER2-sdAb or any of its radiopharmaceutical excipients
  • Known contraindication or hypersensitivity to \[18F\]F-FDG or any of its radiopharmaceutical excipients
  • Concurrent enrollment in another clinical trial evaluating radiopharmaceuticals
  • Patient under guardianship, curatorship, or judicial protection
  • Patient deprived of liberty
  • Inability to understand the study or comply with trial constraints due to linguistic, psychological, or geographical barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Florian Clatot, MD, PhD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Clatot, MD, PhD

CONTACT

+33232082981florian.clatot@chb.uncancer.fr

Doriane Richard, PhD

CONTACT

+33232082985doriane.richard@chb.unicancer.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations

FR(1)