CompletedPhase 3

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

Germany502 participantsStarted 2016-10-24

Plain-language 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-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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ).
✓. Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease
✓. Non-measurable disease

Exclusion criteria

✕. completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of study and
✕. CNS tumor is clinically stable at the time of screening and
✕. Patient is not receiving steroids and enzyme inducing anti-epileptic medications for brain metastases

What they're measuring

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

Timeframe: At 24 weeks after last patient enrolled in trial

Trial details

NCT IDNCT03096847

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-11

Results submitted2021-02-03

View on ClinicalTrials.gov More Advanced Metastatic Breast Cancer trials