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Conditions

Keywords

ribociclibLEE011RIBECCAbreast cancerbreast carcinomaHR-positiveHER2-negativeadvanced breast cancerLetrozoleCDK4/6breast lumpHER2 positivemetastatic breast cancerbreast cancer positive for human epidermal growth factor receptor 2 (HER2) HER2 positive metastatic breast cancerbreast cancer progressionestrogen-receptor (ER) positive(+) breast cancerPaget's disease

Outcome Measures

Primary Outcomes (1)

Clinical Benefit Rate (CBR) in Women and Men With Hormone Receptor Positiv, HER-2 Negative Breast Cancer Treated With Ribocilib and Letrozole
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).
At 24 weeks after last patient enrolled in trial

Secondary Outcomes (10)

Progression Free Survival (PFS) for Different Populations - Kaplan-Meier Estimates (%, 95% CI)
At week 24 , week 48 and week 72
Progression Free Survival (PFS) for Different Populations - Median Time to Progression or Death With 95% CI [Months]

Study Arms (3)

ribociclib + letrozole cohort A

EXPERIMENTAL

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

Drug: ribociclibDrug: letrozoleDrug: goserelin

ribociclib + letrozole cohort B1

EXPERIMENTAL

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

Drug: ribociclibDrug: letrozoleDrug: goserelin

Interventions

ribociclibDrug

All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.

Also known as: LEE011

ribociclib + letrozole cohort Aribociclib + letrozole cohort B1ribociclib + letrozole cohort B2

letrozole

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Study Sites (84)

Novartis Investigative Site

Munich, Bavaria, 80335, Germany

Novartis Investigative Site

Langen, Hesse, 63225, Germany

Novartis Investigative Site

Recklinghausen, North Rhine-Westphalia, 45657, Germany

Novartis Investigative Site

Lübeck, Schleswig-Holstein, 23563, Germany

Novartis Investigative Site

Aachen, 52074, Germany

Novartis Investigative Site

Augsburg, 86150, Germany

Novartis Investigative Site

Berlin, 10117, Germany

Related Publications (1)

Peuker 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: 34953442DERIVED

Brief Summary

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Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (3)

ribociclib + letrozole cohort A

ribociclib + letrozole cohort B1

Interventions

Eligibility Criteria

You may qualify if:

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Study Sites (84)

Related Publications (1)

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ribociclib + letrozole cohort B2

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