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

A Multicenter Phase II/III-study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Diagnostic test: ABY-PET

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lena Franklin, BSc; Phone Number: +46 18 6111761; Email: lena.franklin@akademiska.se
• Study Contact Backup: Name: Tora Sundin; Phone Number: +46 18 6172428; Email: tora.sundin@akademiska.se

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Recruiting
    • Section for Clinical Research & Development Unit
    • Contact: Tora Sundin; Email: tora.sundin@akademiska.se
    • Contact: Lena Franklin; Email: lena.franklin@akademiska.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed written informed consent.
2. Age ≥18 years.

3. 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").
4. Primary breast cancer planned for neoadjuvant therapy (Stage II-III, T2-4N0-3) or metastatic (M1; at least 80 pts).
5. At least one tumor lesion ≥ 10 mm.
6. At least one tumor lesion available for biopsy.
7. 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).
8. WHO performance status ≤ 2.
9. Predicted survival > 12 weeks.
10. 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:

1. Histologically or cytologically confirmed HER2-negative breast cancer defined as IHC 0 or 1+.
2. Other manifest malignancy.
3. Serious uncontrolled concomitant disease including congestive heart failure that would contraindicate the use of any anti-HER2 therapy.

4. 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
5. Patients of childbearing potential and sexually active and not willing to use highly effective contraceptive.
6. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABY-PET; 68Ga-ABY-025 is used as tracer for PET scan	Diagnostic test: ABY-PET; Diagnostic PET for HER2 expression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Henrik Lindman
• Collaborators: Roche Pharma AG; Swedish Breast Cancer Group; Swedish Cancer Society; Affibody
• Investigators: Principal Investigator: Henrik Lindman, Uppsala University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2018
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2025

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ABY-025-MI301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No