18F-FES PET/MRI for tailoring treatment of luminal A and lobular breast cancer: a phase II trial evaluating the performance of FES PET/MRI in axillary staging

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universita' Vita-salute S. Raffaele

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-07-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Fondazione AIRC, Grant ref. 28378

External identifiers

EU CT number

2024-512465-14-00

ClinicalTrials.gov

NCT05982496

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To compare the sensitivity of FES PET/MRI versus axillary ultrasound (US) in detecting macrometastatic lymph nodes (tumor deposit >2mm) in the axilla of BC patients with LumA or Lob who are candidates for axillary surgery for primary surgery.

Secondary objectives 1

1. To compare FES PET/MRI with standard imaging and to investigate potential correlations with recurrence score

Conditions and MedDRA coding

Primary or advanced breast cancer LumA or ER+ Lobular subtypes.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Female patients aged ≥18 years;
2. Able to autonomously sign the informed consent.
3. Patients with diagnosis of LumA or ER-positive Lob;
4. Candidates to surgery as first treatment regardless of clinical nodal (cN) status.
5. Normal hepatic and renal function
6. Women of Child-Bearing Potential (WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile for hysterectomy, bilateral salpingectomy and bilateral oophorectomy) accepting to use highly effective contraceptive measures for the whole duration of the trial (i.e. Intrauterine device with no hormone releasing system, sexual abstinence, in case of tubal ligation or partner undergone vasectomy, condom with or without spermicide, cap, diaphragm or sponge with spermicide).
7. Translational group • Patients with large (>2cm) tumors with heterogeneity on imaging (FES uptake unevenly distributed within the same or multiple lesion) or/and final pathology (presence of different cell populations or histotypes within the same or multiple lesions).

Exclusion criteria 10

1. ER-negative tumors;
2. Metastatic patients.
3. Pregnancy;
4. Breast-feeding women;
5. Women on low-sodium diet;
6. History of epilepsy
7. Current assumption of ER-antagonists (i.e. tamoxifen suspended less than 8 weeks before or fulvestrant suspended less than 28 weeks before the exam)
8. Contraindications to PET (i.e. uncontrolled diabetes);
9. Contraindications to MRI (i.e. Claustrophobia, Allergy to the MR contrast agent, Severe renal insufficiency, pacemaker);
10. Translational group • No sign of heterogeneity on imaging or final pathology • No availability of sufficient tissue samples for analyses

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Sensitivity (SE) of FES PET/MRI and axillary ultrasound (US) to detect macrometastatic (tumor deposit>2mm) axillary lymph nodes with the goal of demonstrating the superiority of FES PET/MRI over US.

Secondary endpoints 3

1. Specificity, positive predictive value, negative predictive value, and overall accuracy of FES PET/MRI.
2. Comparison FES PET/MRI vs standard imaging. Results from FES PET/MRI will be compared with standard imaging in terms of sensitivity and number of lesions with FES uptake versus previously known lesions from all preoperative exams (mammography, ultrasound or any exam performed as preoperative routine).
3. Correlation between recurrence score and FES PET/MRI findings and parameters will be investigated. This analysis will include a subset of patients for whom Oncotype DX will be performed after surgery according to standard indications. The recurrence score will be correlated to the quantitative imaging PET parameters (SUVmax, SUVmean, MTV, TLG).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universita' Vita-salute S. Raffaele

Sponsor organisation

Universita' Vita-salute S. Raffaele

Address

Via Olgettina 58

City

Milan

Postcode

20132

Country

Italy

Scientific contact point

Organisation

Universita' Vita-salute S. Raffaele

Contact name

Clinical Trial Center - Trial Startup Unit

Public contact point

Organisation

Universita' Vita-salute S. Raffaele

Contact name

Clinical Trial Center - Trial Startup Unit

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications