Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03096847
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2017-03-10
Brief Title:
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A National Phase IIIb Multi-center Open Label Study for Women and Men With Hormone-receptor Positive HER-2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Ribociclib LEE011 in Combination With Letrozole
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a national multi-center open-label phase IIIb trial to determine the efficacy and safety of treatment with ribociclib LEE011 plus letrozole in patients with HR HER2-negative advanced recurrent or metastatic breast cancer Patients were treated with daily doses of 600 mg ribociclib 3-weeks-on1-week-off schedule in combination with 25 mg letrozole daily continuous dosing Dose adjustments dose reduction or interruption according to safety findings were allowed
Detailed Description:
The main purpose of this study was to collect additional efficacy and safety data for the combination of ribociclib and letrozole in a patient population broader than the MONALEESA-2 study NCT01958021 CLEE011A2301 and to provide access to ribociclib to patients for which available treatment options are unsatisfactory treatment alternatives until the drug is approved for this indication Furthermore this trial aimed to collect data for the combination of ribociclib and letrozole in the context of current local routine therapy algorithms for the treatment of metastatic and advanced breast cancer
This multi-center open-label single-arm study aimed to evaluate the efficacy safety and quality of life for the combination of ribociclib and letrozole in a patient population than in the MONALEESA-2 study ie in patients pretreated with one line of chemotherapy andor a maximum of two lines of endocrine therapy as well as premenopausal patients without limitations regarding the disease free interval after adjuvant therapy
For ethical reasons no endocrine comparator drugs were investigated in this study The duration of study treatment of 80 weeks was adequate to determine the primary secondary and exploratory study parameters The sample size was suitable to estimate the clinical benefit rate CBR in this patient population with reasonable precision
Goserelin was used in premenopausal patients since it was shown that ovarian suppression of estrogen release with luteinizing hormone-releasing hormone agonists LHRHa such as goserelin is effective in preventing relapse in premenopausal women with early stage ER breast cancer Klijn et al 2001
The efficacy and safety of ribociclib in combination with letrozole for the treatment of postmenopausal women with advanced or metastatic breast cancer vs placebo ie letrozole alone was already demonstrated in the preceding pivotal MONALESSA-2 study Thus for ethical reasons no endocrine comparator drugs were investigated in the present RIBECCA study
Generally the single-arm open-label design and the broadening of the study population compared to the pivotal MONALESSA-2 study in the RIBECCA study was deemed appropriate to further evaluate the efficacy and safety of ribociclib plus letrozole among breast cancer patients in a treatment setting closer to routine care The duration of study treatment of up to 80 weeks was considered adequate to determine the primary secondary and exploratory study parameters Moreover the sample size was suitable to estimate the CBR in this patient population with reasonable precision
This multi-center open-label single-arm study aimed to evaluate the efficacy safety and quality of life for the combination of ribociclib and letrozole in a patient population than in the MONALEESA-2 study ie in patients pretreated with one line of chemotherapy andor a maximum of two lines of endocrine therapy as well as premenopausal patients without limitations regarding the disease free interval after adjuvant therapy
For ethical reasons no endocrine comparator drugs were investigated in this study The duration of study treatment of 80 weeks was adequate to determine the primary secondary and exploratory study parameters The sample size was suitable to estimate the clinical benefit rate CBR in this patient population with reasonable precision
Goserelin was used in premenopausal patients since it was shown that ovarian suppression of estrogen release with luteinizing hormone-releasing hormone agonists LHRHa such as goserelin is effective in preventing relapse in premenopausal women with early stage ER breast cancer Klijn et al 2001
The efficacy and safety of ribociclib in combination with letrozole for the treatment of postmenopausal women with advanced or metastatic breast cancer vs placebo ie letrozole alone was already demonstrated in the preceding pivotal MONALESSA-2 study Thus for ethical reasons no endocrine comparator drugs were investigated in the present RIBECCA study
Generally the single-arm open-label design and the broadening of the study population compared to the pivotal MONALESSA-2 study in the RIBECCA study was deemed appropriate to further evaluate the efficacy and safety of ribociclib plus letrozole among breast cancer patients in a treatment setting closer to routine care The duration of study treatment of up to 80 weeks was considered adequate to determine the primary secondary and exploratory study parameters Moreover the sample size was suitable to estimate the CBR in this patient population with reasonable precision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-002556-24 | EUDRACT_NUMBER | Novartis | None |
| CLEE011XDE01 | OTHER | None | None |