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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer

NCTNCT03096847 (opens ClinicalTrials.gov in a new tab)Other idCLEE011XDE01Other idCLEE011XDE01Other id2016-002556-24Other id2016
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
502 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Germany

Start
24 Oct 2016
Primary completion
11 Dec 2018
Completion
6 Feb 2020
First posted
30 Mar 2017
Last update posted
11 Oct 2021
Conditions
Advanced Metastatic Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018201920202021
  1. Ph 3

    Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer

    NCT03096847

    24 Oct 2016 to 6 Feb 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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-on/1-week-off schedule) in combination with 2.5 mg letrozole daily (continuous dosing). Dose adjustments (dose reduction or interruption) according to safety findings were allowed.

Interventions

  • ribociclibDrug
  • letrozoleDrug
  • goserelinDrug

Arms3

  • Experimental

    ribociclib + letrozole cohort A

    ribociclib + letrozole cohort A - postmenopausal women, or men; naïve. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.

  • Experimental

    ribociclib + letrozole cohort B1

    ribociclib + letrozole cohort B1 - premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly

  • Experimental

    ribociclib + letrozole cohort B2

    ribociclib + letrozole cohort B2 - premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Clinical Benefit Rate (CBR) in Women and Men With Hormone Receptor Positiv, HER-2 Negative Breast Cancer Treated With Ribocilib and Letrozole

    Time frame · At 24 weeks after last patient enrolled in trial

    Registry description

    Clinical Benefit Rate (CBR) after 24 weeks of treatment as defined by RECIST 1.1 as percentage of patients with Complete Response (CR), Partial response (PR) or Stable disease (SD) lasting 24 weeks or longer as well as patients with Non-complete response, nonprogressive disease (NCRNPD).

Secondary outcomes(10)

  1. Progression Free Survival (PFS) for Different Populations - Kaplan-Meier Estimates (%, 95% CI)

    Time frame · At week 24 , week 48 and week 72

    Registry description

    PFS based on radiologic assessment by investigator using RECIST 1.1 criteria

  2. Progression Free Survival (PFS) for Different Populations - Median Time to Progression or Death With 95% CI [Months]

    Time frame · Up to approximately month 25

    Registry description

    PFS based on radiologic assessment by investigator using RECIST 1.1 criteria

  3. Overall Survival (OS) - Kaplan-Meier Estimates (%, 95% CI)

    Time frame · At Week 24, Week 48 and Week 72

    Registry description

    Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause. For the Kaplan-Meier estimates (%, 95% CI), the probability of survival at week 24, 48 and 72 is reported below.

  4. Overall Survival (OS) - Median Time to Progression or Death With 95% CI [Months]

    Time frame · Up to approximatley 38 months

    Registry description

    Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause.

  5. Overall Survival (OS) - Number of Censored Participants and Number of Deaths

    Time frame · Up to approximatley 38 months

    Registry description

    Overall survival (OS) defined as the time from date of start of treatment to date of death due to any cause.

  6. Overall Response Rate (ORR) - Kaplan-Meier Estimates (%, 95% CI)

    Time frame · At week 24

    Registry description

    Overall response rate (ORR) is the best overall response (BOR) of complete response (CR) or partial response (PR) as defined by RECIST 1.1.

  7. Change From Baseline at Week 24 of Patient Reported Quality of Life (QoL) Via EORTC QLQ-C30

    Time frame · Change from Baseline to Week 24

    Registry description

    The QLQ-C30 is the core questionnaire of the EORTC QLQ, which has been developed for the assessment of the health-related QOL of cancer patients participating in international clinical trials. Using a linear transformation to standardize the raw scores, all scores finally range from 0 to 100, where a higher score represents a higher response level, e.g., a higher ("better") level of functioning (applies to the first 6 items, items 1 to 6), but a higher ("worse") level of symptoms (applies to the last 9 items, items 7 to 15). There is no aggregated total score, i.e., all scale scores were analyzed separately.

  8. Patient Reported Quality of Life (QoL) Via EORTC BR-23 - Change From Baseline at Week 24 (Cycle 7)

    Time frame · Baseline and Week 24 (Cycle 7)

    Registry description

    To evaluate health related quality of life (QoL) via EORTC BR-23. The scoring approach for the QLQ-BR23 is identical in principle to that for the function and symptom scales / single items of the QLQ-C30, i.e., all scores finally range from 0 to 100, where a higher score represents a higher response level, e.g., a higher ("better") level of functioning, (applies to the first 4 items, items 1 to 4) but a higher ("worse") level of symptoms (applies to the last 4 items, items 5 to 8).

  9. Time to 10% Deterioration in EORTC Global Health Status

    Time frame · up to approximately 10 months

    Registry description

    Time to 10% deterioration in the European Organisation for Research and Treatment of Cancer (EORTC) global health status

  10. Number of Participants With Treatment Emergent Adverse Events (TEAE)

    Time frame · Up to Week 72

    Registry description

    Adverse Events (AEs) were separated into TEAEs (defined as AEs occurring/worsening from first study drug treatment until 30 days after the last study drug treatment) and AEs in the pre-/post-treatment period.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· At 24 weeks after last patient enrolled in trial

Clinical Benefit Rate (CBR) in Women and Men With Hormone Receptor Positiv, HER-2 Negative Breast Cancer Treated With Ribocilib and Letrozole

GroupValue (Percentage of Participants)
Ribociclib + Letrozole Cohort A63.2
Ribociclib + Letrozole Cohort B157.7
Ribociclib + Letrozole Cohort B256.5
Total60.8
Secondary and other outcome results(7)
Secondary outcomeNumber· At week 24 , week 48 and week 72

Progression Free Survival (PFS) for Different Populations - Kaplan-Meier Estimates (%, 95% CI)

GroupValue (Percentage of Participants)
Ribociclib + Letrozole Cohort A73.1
Ribociclib + Letrozole Cohort B167.0
Ribociclib + Letrozole Cohort B263.8
Secondary outcomeMedian· Up to approximately month 25

Progression Free Survival (PFS) for Different Populations - Median Time to Progression or Death With 95% CI [Months]

GroupValue (Months)
Ribociclib + Letrozole Cohort A21.8
Ribociclib + Letrozole Cohort B116.5
Ribociclib + Letrozole Cohort B28.8
Secondary outcomeNumber· At Week 24, Week 48 and Week 72

Overall Survival (OS) - Kaplan-Meier Estimates (%, 95% CI)

GroupValue (Percentage of Participants)
Ribociclib + Letrozole Cohort A98.6
Ribociclib + Letrozole Cohort B1100.0
Ribociclib + Letrozole Cohort B293.9
Secondary outcomeMedian· Up to approximatley 38 months

Overall Survival (OS) - Median Time to Progression or Death With 95% CI [Months]

GroupValue (Months)
Ribociclib + Letrozole Cohort ANA
Ribociclib + Letrozole Cohort B1NA
Ribociclib + Letrozole Cohort B2NA
Secondary outcomeNumber· Up to approximatley 38 months

Overall Survival (OS) - Number of Censored Participants and Number of Deaths

GroupValue (Participants)
Ribociclib + Letrozole Cohort A240
Ribociclib + Letrozole Cohort B117
Ribociclib + Letrozole Cohort B294
Secondary outcomeNumber· At week 24

Overall Response Rate (ORR) - Kaplan-Meier Estimates (%, 95% CI)

GroupValue (Percentage of Participants)
Ribociclib + Letrozole Cohort A22.8
Ribociclib + Letrozole Cohort B123.1
Ribociclib + Letrozole Cohort B211.7
Secondary outcomeMean· Change from Baseline to Week 24

Change From Baseline at Week 24 of Patient Reported Quality of Life (QoL) Via EORTC QLQ-C30

GroupValue (Scores on a scale)Spread
Ribociclib + Letrozole Cohort A8.823.7
Ribociclib + Letrozole Cohort B111.720.8
Ribociclib + Letrozole Cohort B25.026.2
Ribociclib + Letrozole Cohort B6.125.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Ribociclib + Letrozole Cohort Apostmenopausal women, or men; naïve. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily.6 / 31997 / 319315 / 319
Ribociclib + Letrozole Cohort Bpremenopausal women or perimenopausal women or postmenopausal women, or men; naïve + pre-treated All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o.daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly6 / 18350 / 183181 / 183
Ribociclib + Letrozole Cohort B1premenopausal women or perimenopausal women; naïve All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly0 / 265 / 2625 / 26
Ribociclib + Letrozole Cohort B2premenopausal women or perimenopausal women or postmenopausal women, or men; pre-treated. All patients received ribociclib 600mg p.o. daily + Letrozole 2.5 mg p.o. daily. Premenopausal patients additionally received goserelin 3.6 mg i.m. monthly6 / 15745 / 157156 / 157
TotalTotal12 / 502147 / 502496 / 502

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPeuker CA, Yaghobramzi S, Grunert C, Keilholz L, Gjerga E, Hennig S, Schaper S, Na IK, Keller U, Brucker S, Decker T, Fasching P, Fehm T, Janni W, Kummel S, Schneeweiss A, Schuler M, Luftner D, Busse A. Treatment with ribociclib shows favourable immunomodulatory effects in patients with hormone receptor-positive breast cancer-findings from the RIBECCA trial. Eur J Cancer. 2022 Feb;162:45-55. doi: 10.1016/j.ejca.2021.11.025. Epub 2021 Dec 23. PMID 34953442

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patient is an adult, ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines * Women and men with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. * Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory. Local pathology is sufficient for assessment. * Patient must have either: 1. Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ). 2. Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease 3. Non-measurable disease * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 Exclusion Criteria * Patient who received any CDK4/6 inhibitor or any mTOR inhibitor. * Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole * Patients with current inflammatory breast cancer. * Patient has received \> 1 chemotherapy for the treatment of advanced/metastatic breast cancer * Patient has received \> 2 endocrine therapies for the treatment of advanced/metastatic breast cancer * Patient has central nervous system (CNS) involvement. If patient is fulfilling the following 3 criteria she/he is eligible for the trial. 1. completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of study and 2. CNS tumor is clinically stable at the time of screening and 3. Patient is not receiving steroids and enzyme inducing anti-epileptic medications for brain metastases * Patient has active cardiac disease or a history of cardiac dysfunction

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