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Selecteren van de optimale plaats van CDK4/6-remmer bij de behandeling van uitgezaaide hormoongevoelige (HR+) borstkanker: de SONIA studie


- candidate number27342
- NTR NumberNTR6494
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jun-2017
- Secondary IDsNL62197.031.17 // 2017-002334-23 NL  Toetsingonline // EudraCT
- Public TitleSelecteren van de optimale plaats van CDK4/6-remmer bij de behandeling van uitgezaaide hormoongevoelige (HR+) borstkanker: de SONIA studie
- Scientific TitleSelecting the Optimal position of CDK4/6 Inhibitors in HR+ Advanced breast cancer: the SONIA study.
- ACRONYMSONIA
- hypothesisTreatment 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) studiedMamma carcinoma, Breast cancer
- Inclusion criteria1. 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 loco-regional recurrent or metastatic HR+ disease.
- Exclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2017
- planned closingdate1-okt-2022
- Target number of participants1050
- InterventionsPalbociclib
- Primary outcomeProgression-free survival after two lines of treatment
- Secondary outcome- Overall survival
- Objective response
- Quality of life
- Cost-effectiveness
- Timepoints-
- Trial web sitewww.sonia-studie.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Jeany M. Rademaker-Lakhai
- CONTACT for SCIENTIFIC QUERIESDr. Jeany M. Rademaker-Lakhai
- Sponsor/Initiator BOOG study center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThis 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), CDK4/6 inhibitor 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)Changes - 10-apri-2018 - MT

- Expanding inclusion and exclusion criteria:
♣ Evaluable disease according to RECIST is sufficient for inclusion (also patients with no target lesions, other than bone only disease, are allowed to participate);
♣ If patients have already started palliative endocrine therapy (<21 days before randomization), they may still be included
- Optimizing the dose modification schemes;
- Starting up two optional 'side studies' (pharmacokinetics / dynamics / genetics and 'liquid biopsies') (extra blood tests)

INCLUSION CRITERIA
3. Previously untreated with any systemic anti-cancer therapy for loco-regional recurrent or metastatic HR+ disease.
Replaced by
3. Previously untreated with any systemic anti-cancer therapy for loco-regional recurrent or metastatic HR+ disease, with the exception of recently started (within 21 days of randomization) endocrine treatment..

EXCLUSION CRITERIA
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.
Replaced by
3. Prior neoadjuvant or adjuvant treatment with an aromatase inhibitor with disease recurrence while on or within 12 months of treatment.

INTERVENTION
- Addition of ribociclib as alternative CDK4/6 inhibitor (only in first line as ribociclib is only registered in first-line treatment)

SECONDARY OUTCOME NEW:
- Adverse events
- RECORD1-jun-2017 - 10-apr-2018


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