Can molecular imaging predict outcome to firstline endocrine treatment ± CDK 4/6 inhibition in advanced ER+ breast cancer?

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1. Adult women (>= 18 years of age) with proven diagnosis of adenocarcinoma of
the breast with locoregional recurrent or metastatic disease not amenable to
resection or radiation therapy with curative intent and for whom chemotherapy
is not clinically indicated.
2. Previously untreated with any systemic anti-cancer therapy for metastatic
HR+ disease, with the exception of recently started (within 14 days of start
treatment) endocrine therapy.
Special considerations:
a. Previous systemic treatment for locoregional recurrent disease is not an
exclusion criterion, provided that the intent was curative at the time of
systemic therapy.
b. In case of previous systemic treatment for oligometastatic disease, patients
are not eligible for SONImage
3. Documentation of histologically confirmed diagnosis of ER expression >10%
breast cancer
based on local results (on the primary tumor or on a metastatic lesion).
4. Patients that are planned to start with an aromatase inhibitor + CDK 4/6
inhibitors within 28
days of signing informed consent.
5. Women who are not post-menopausal must receive ovarian ablation or
suppression with
administration of LHRH agonist. Postmenopausal status is defined as:
a. prior bilateral surgical oophorectomy, or
b. for patients >=60 years: spontaneous cessation of regular menses for at least
12 consecutive months without OAC;
c. for patients <60 years: spontaneous cessation of regular menses for at least
12 consecutive months without OAC ánd estradiol and FSH levels that meet
postmenopausal values according to local reference values at screening
6. Able to give written informed consent and to comply with the SONImage
protocol.

Exclusion Criteria

1. Contra-indication for aromatase inhibitors.
2. Contra-indication for PET imaging.
3. Use of ER ligands (i.e., tamoxifen or fulvestrant) <= 5 weeks before FES-PET
imaging.
4. Use of CDK4/6 inhibitor before FES-PET or FDG-PET imaging.
5. Use of aromatase inhibitors > 2 weeks before FES-PET or FDG- PET imaging.
Prior to FDG/FES-PET CT imaging performed after PFS1 before start of second line
fulvestrant ± CDK 4/6 inhibition, the same in- and exclusion criteria apply. In
addition:
1. Patients must be included in SONImage at start of first line therapy.
2. Patients are excluded when there is a contra-indication for fulvestrant
3. Patients are excluded when fulvestrant is used > 2 weeks before FDG-PET
imaging
4. Patients are excluded when fulvestrant is used before FES-PET imaging

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study parameters and endpoints are entirely the same as in the original<br /><br>SONImage side study.<br /><br>The primary study endpoint (1) is PFS (according to RECIST 1.1 criteria,<br /><br>Appendix 1) after first line treatment (PFS1).</p><br>

Secondary Outcome Measures