Using 68Ga-ABY-025 PET to Measure HER2 Expression in Advanced Breast Cancer
A Multicenter Phase II/III-study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer
This study is testing a new type of imaging to see if it can accurately measure HER2 levels in patients with advanced HER2-positive breast cancer to help guide their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Hospital Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT03655353 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of 68Ga-ABY-025 PET imaging to non-invasively quantify HER2 expression in patients with advanced HER2-positive breast cancer. It aims to correlate the PET imaging results with standard histopathological assessments from tumor biopsies. The study involves multiple centers and focuses on patients who are candidates for neoadjuvant therapy or have metastatic disease. By comparing imaging results with biopsy data, the study seeks to improve the understanding of HER2 expression in breast cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed HER2-positive or borderline positive breast cancer who are planned for neoadjuvant therapy or have metastatic disease.
Not a fit: Patients with HER2-negative breast cancer or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive method for assessing HER2 expression, potentially leading to more personalized treatment strategies for patients.
How similar studies have performed: Other studies have explored imaging techniques for HER2 expression, but the specific use of 68Ga-ABY-025 PET in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Uppsala
- Section for Clinical Research & Development Unit — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Henrik Lindman — Uppsala University Hospital
- Study coordinator: Lena Franklin, BSc
- Email: lena.franklin@akademiska.se
- Phone: +46 18 6111761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.