|- candidate number||27342|
|- NTR Number||NTR6494|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-jun-2017|
|- Secondary IDs||NL62197.031.17 // 2017-002334-23 NL Toetsingonline // EudraCT|
|- Public Title||Selecteren van de optimale plaats van CDK4/6-remmer bij de behandeling van uitgezaaide hormoongevoelige (HR+) borstkanker: de SONIA trial
|- Scientific Title||Selecting the Optimal position of CDK4/6 Inhibitors in HR+ Advanced breast cancer: the SONIA trial.|
|- hypothesis||Treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free survival compared to treatment with a non-steroidal aromatase inhibitor in first line followed at progression by fulvestrant combined with CDK4/6 inhibition in second line (strategy B) in women with HR+/HER2- metastatic breast cancer who have not received any prior systemic anti-cancer therapy for metastatic disease.|
|- Healt Condition(s) or Problem(s) studied||Mamma carcinoma, Breast cancer|
|- Inclusion criteria||1. Adult women (¡Ý 18 years of age) with proven diagnosis of adenocarcinoma of the breast with evidence of 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 loco-regional recurrent or metastatic HR+ disease.
|- Exclusion criteria||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.
|- mec approval received||no|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2017|
|- planned closingdate||1-okt-2022|
|- Target number of participants||1050|
|- Primary outcome||Progression-free survival after two lines of treatment|
|- Secondary outcome||- Overall survival|
- Objective response
- Quality of life
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. Jeany M. Rademaker-Lakhai|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Jeany M. Rademaker-Lakhai|
|- Sponsor/Initiator ||BOOG study center|
(Source(s) of Monetary or Material Support)
|- Brief summary||This is a nationwide, multicentre, randomized phase 3 study in 1,050 patients that compares two strategies in the treatment of women with HR+/HER2- metastatic breast cancer who have not received any prior systemic anti-cancer therapy for metastatic disease. Strategy A prescribes a non-steroidal aromatase inhibitor plus CDK4/6 inhibitor in first line followed by fulvestrant in second line. Strategy B prescribes a non-steroidal aromatase inhibitor in first line followed by fulvestrant plus CDK4/6 inhibitor in second line. Patients will be stratified by site of disease (visceral versus non-visceral), prior endocrine treatment in (neo)adjuvant setting (yes vs. no), and hospital.|
Primary endpoint is progression-free survival after two lines of treatment (PFS2) defined as time from randomization until objective disease progression, symptomatic deterioration, or unacceptable toxicity on second line treatment, death, strategy violation, or withdrawal of consent, whichever occurs first. Secondary endpoints are overall survival, quality of life, safety and tolerability of CDK4/6 inhibitor, and objective response rate.
|- Main changes (audit trail)|
|- RECORD||1-jun-2017 - 10-jul-2017|