Selecting the Optimal position of CDK4/6 Inhibitors in HR+ Advanced breast cancer: the SONIA trial
- Conditions
- Breast cancerMammary carcinoma10006291
- Registration Number
- NL-OMON53036
- Lead Sponsor
- BOOG Study Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1050
Main study
1. Adult women (>= 18 years of age) with proven diagnosis of adenocarcinoma of
the breast with loco-regional recurrent or metastatic disease not amenable to
resection or radiation therapy with curative intent and for whom chemotherapy
is not clinically indicated., 2. Documentation of histologically or
cytologically confirmed diagnosis of estrogen receptor (ER) expression >10%
and/or progesterone receptor (PR) expression >10% breast cancer based on local
laboratory results. 3. Previously untreated with any systemic anti-cancer
therapy for metastatic HR+ disease, with the exception of recently started
(within 28 days of randomization) 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 SONIA
Substudy ctDNA/pharmacogenetics & -kinetics:
No additional inclusion criteria
Substudy SONImage:
1. Patient is eligible and participates in the SONIA trial for ER+ advanced
breast cancer.
2. Able to give written informed consent and to comply with the SONImage
protocol.
3. Documentation of histologically confirmed diagnosis of estrogen receptor
(ER) expression >10% breast cancer based on local results. The receptor status
can be determined on the primary tumor or on a tumor biopsy of a metastatic
lesion.
Substudy SONIA EfFECT (cognitive testing):
No additional inclusion criteria.
Main study:
1. Patients with advanced, symptomatic, visceral spread, who are at risk of
life-threatening complications in the short term. 2. Known active uncontrolled
or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal
disease. 3. Prior neoadjuvant or adjuvant treatment with a non-steroidal
aromatase inhibitor (i.e., anastrozole or letrozole) with disease recurrence
while on or within 12 months of treatment. 4. Prior treatment with any CDK4/6
inhibitor. 5. Patients treated within the last 7 days prior to randomization
with:
a. Food or drugs that are known to be CYP3A4 inhibitors
b. Drugs that are known to be CYP3A4 inducers
Substudy SONImage:
1. Contra-indication for PET imaging.
2. Use of estrogen receptor ligands (i.e. tamoxifen or fulvestrant) < 5 weeks
before FES-PET imaging.
Substudy SONIA EfFECT (cognitive testing):
No additional exlucion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters/outcome of the study:<br /><br>The primary endpoint of the study is progression-free survival after two lines<br /><br>of treatment (PFS2) defined as time from randomization until one of the<br /><br>following (whichever occurs first):<br /><br>- second objective disease progression or objective disease progression on<br /><br>second-line therapy, whichever occurs first<br /><br>- symptomatic deterioration on second-line therapy leading to discontinuation<br /><br>of second-line therapy<br /><br>- initiation of chemotherapy for breast cancer<br /><br>- death</p><br>
- Secondary Outcome Measures
Name Time Method <p>The main study has several secondary endpoints, including<br />- overall survival<br />- quality of life<br />- safety and tolerability<br />- objective response rate (ORR)<br />- progression-free survival after first-line therapy (PFS1)<br /><br />Each substudy has its own endpoints.<br />Circulating tumorDNA (ctDNA) & pharmacogenetics/-kinetics (PG/PK): differences<br />in ctDNA and PG/PK-characteristics between responders and non-responders to<br />therapy; for PG/PK side effects will also be an endpoint.<br />Nulcear imaging (SONImage): PFS1, as defined in SONIA, correlated to<br />FES-/FDG-PET-characteristics.<br />Cognitive testing (SONIA EfFECT): the difference between baseline cognitive<br />score and the cognitive score after 9 months of study treatment. </p>