A multicenter phase II/III-study of 68Ga-ABY-025 PET for non-invasive quantification of HER2-expression in advanced breast cancer

Phase 1

• Conditions: Breast cancer.; MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002115-34-SE
• Lead Sponsor: Region Uppsala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Last Update Posted: 25 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

* 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:
a.3+ by immunohistochemistry [IHC] in >10% of cell areas.
b.2+ 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:
c.2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number 4.0 - 6.0 by in situ hybridization [ISH]) (equivocal”).
d.2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number <4.0 by in situ hybridization [ISH]) (2+ ISH negative”).
e.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.
* Predicted survival > 12 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

* 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 adequate contraceptive.
* Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified