A Study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer (Affibody-3)

Henrik Lindman

Status

Enrolling

Conditions

HER2-positive Breast Cancer

Treatments

Diagnostic Test: ABY-PET

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03655353

ABY-025-MI301

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:
1. 3+ by immunohistochemistry [IHC] in >10% of cell areas.
2. 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:
3. 2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number 4.0 - 6.0 by in situ hybridization [ISH]) ("equivocal").
4. 2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number <4.0 by in situ hybridization [ISH]) ("2+ ISH negative").
5. 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.
Negative pregnancy test in women of childbearing potential (premenopausal or <12 months of amenorrhea post-menopause and who have not undergone surgical sterilization). Women of childbearing potential must use highly effective method of contraception, i.e combined hormonal contraception, or progestogen-only hormonal contraception, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion, or vasectomized partner, or sexual abstinence

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