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Trial record 1 of 1 for:    affibody-3 | Sweden
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A Study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer (Affibody-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03655353
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : September 7, 2018
Roche Pharma AG
Swedish Cancer Society
Swedish Breast Cancer Group
Information provided by (Responsible Party):
Henrik Lindman, Uppsala University Hospital

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.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Diagnostic Test: ABY-PET Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Investigators will determine HER2 expression by ABY-PET without knowledge of the results from the biopsies (in Phase III part).
Primary Purpose: Diagnostic
Official Title: A Multicenter Phase II/III-study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. HER2- expression by using 68Ga-ABY-025 PET. [ Time Frame: Approximately 10 days after study entry. ]
    HER2-expression in tumors measured by 68Ga-ABY-025 PET, centrally analysed and result used for location of biopsy.

  2. HER2-expression by analysing biopsy sample. [ Time Frame: Approximately 21 days after study entry. ]
    HER2-expression in tumors by histopathology. Location of biopsy site based on HER2 expression seen in ABY-PET.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03655353

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Contact: Lena Franklin, BSc +46 18 6111761
Contact: Tora Sundin +46 18 6172428

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Section for Clinical Research & Development Unit Recruiting
Uppsala, Sweden, 75185
Contact: Tora Sundin   
Contact: Lena Franklin   
Sponsors and Collaborators
Henrik Lindman
Roche Pharma AG
Swedish Cancer Society
Swedish Breast Cancer Group
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Principal Investigator: Henrik Lindman Uppsala University Hospital
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Responsible Party: Henrik Lindman, Coordinating Investigator, Uppsala University Hospital Identifier: NCT03655353    
Other Study ID Numbers: ABY-025-MI301
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases