No registrations found.
ID
Source
Brief title
Health condition
Mammary carcinoma; breast cancer; mammacarcinoom; borstkanker
Sponsors and support
- Zorgverzekeraars Nederland
Intervention
Outcome measures
Primary outcome
Progression-free survival after two lines of treatment
Secondary outcome
- Overall survival
- Objective response
- Quality of life
- Cost-effectiveness
- Adverse events
Background 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), 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.
Study objective
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.
Study design
-
Intervention
Palbociclib, ribociclib or abemaciclib
Elise van Leeuwen-Stok
BOOG Study Center
Amsterdam 1006 AE
The Netherlands
088-234 67 30
info@boogstudycenter.nl
Elise van Leeuwen-Stok
BOOG Study Center
Amsterdam 1006 AE
The Netherlands
088-234 67 30
info@boogstudycenter.nl
Inclusion criteria
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 loco-regional recurrent or metastatic HR+ disease, with the exception of recently started (within 28 days of randomization) endocrine treatment.
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.
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 an aromatase inhibitor with disease recurrence while on or within 12 months of treatment.
4. Prior treatment with any CDK4/6 inhibitor.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6319 |
| NTR-old | NTR6494 |
| CCMO | NL62197.031.17 |
| OMON | NL-OMON53036 |