NCT03655353

Brief Summary

A large multi- center phase II/III study with 68Ga-ABY-025 PET and biopsies in patients with advanced HER2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 68Ga-ABY-025 PET and standard histopathology from relevant tumor biopsies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 22, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

6.2 years

First QC Date

August 30, 2018

Last Update Submit

September 28, 2021

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • HER2- expression by using 68Ga-ABY-025 PET.

    HER2-expression in tumors measured by 68Ga-ABY-025 PET, centrally analysed and result used for location of biopsy.

    Approximately 10 days after study entry.

  • HER2-expression by analysing biopsy sample.

    HER2-expression in tumors by histopathology. Location of biopsy site based on HER2 expression seen in ABY-PET.

    Approximately 21 days after study entry.

Study Arms (1)

ABY-PET

EXPERIMENTAL

68Ga-ABY-025 is used as tracer for PET scan

Diagnostic Test: ABY-PET

Interventions

ABY-PETDIAGNOSTIC_TEST

Diagnostic PET for HER2 expression

ABY-PET

Eligibility Criteria

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

You may qualify if:

  • Signed written informed consent.
  • Age ≥18 years.
  • Histologically or cytologically confirmed HER2-positive or borderline positive (for definition see below) adenocarcinoma of the breast.
  • HER2-positive defined as:
  • + by immunohistochemistry \[IHC\] in \>10% of cell areas.
  • + by IHC in \>10% of cell areas and HER2/CEP17 ratio ≥2.0 or HER2 copy number ≥ 6.0 by in situ hybridization \[ISH\]).
  • HER2-borderline positive defines as:
  • + by IHC and HER2/CEP17 ratio \<2.0 and/or HER2 copy number 4.0 - 6.0 by in situ hybridization \[ISH\]) ("equivocal").
  • + by IHC and HER2/CEP17 ratio \<2.0 and/or HER2 copy number \<4.0 by in situ hybridization \[ISH\]) ("2+ ISH negative").
  • Known inhomogeneous HER2-expression in the primary tumor with HER2-positive areas \<10% ("inhomogeneous").
  • Primary breast cancer planned for neoadjuvant therapy (Stage II-III, T2-4N0-3) or metastatic (M1; at least 80 pts).
  • At least one tumor lesion ≥ 10 mm.
  • At least one tumor lesion available for biopsy.
  • Newly diagnosed or confirmed progression and planned for therapy with trastuzumab emtansine or anti-HER2 targeted therapy(-ies) concomitant with chemotherapy (HER2-positive cohort) or chemotherapy (HER2-negative patients).
  • WHO performance status ≤ 2.
  • +2 more criteria

You may not qualify if:

  • Histologically or cytologically confirmed HER2-negative breast cancer defined as IHC 0 or 1+.
  • Other manifest malignancy.
  • Serious uncontrolled concomitant disease including congestive heart failure that would contraindicate the use of any anti-HER2 therapy.
  • Inadequate organ function, suggested by the following laboratory results:
  • Absolute neutrophil count \<1,500 cells/mm3
  • Total bilirubin ≥1.5 x ULN (unless the patient has documented Gilbert's syndrome)
  • AST (SGOT) or ALT (SGPT) \>5.0 × ULN
  • Serum creatinine clearance \<30 ml/min
  • Patients of childbearing potential and sexually active and not willing to use highly effective contraceptive.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section for Clinical Research & Development Unit

Uppsala, 75185, Sweden

RECRUITING

Study Officials

  • Henrik Lindman

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Franklin, BSc

CONTACT

+46 18 6111761lena.franklin@akademiska.se

Tora Sundin

CONTACT

+46 18 6172428tora.sundin@akademiska.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Investigators will determine HER2 expression by ABY-PET without knowledge of the results from the biopsies (in Phase III part).
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

August 30, 2018

First Posted

August 31, 2018

Study Start

August 22, 2018

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

SE(1)