Health Trials

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

ConditionEarly Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).

Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.

Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.

Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.

Disqualifiers

Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.

Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.

Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.

Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ribociclib

    Drug

    Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest

  • Letrozole

    Drug

    Letrozole 2.5 mg orally once daily continuously

  • Ansastrozole

    Drug

    Anastrozole 1 mg orally once daily continuously.

  • Goserelin

    Drug

    Goserelin administered subcutaneously at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used

  • Leuprolide

    Drug

    Leuprolide administered subcutaneously at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used

  • Exemestane

    Drug

    Exemestane 25 mg once daily continuously

Treatment groups

1,400 Participants
are divided into 1 treatment group
Group A: Ribociclib + endocrine therapyExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years

iBCFS is defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or contralateral invasive BC. iBCFS will be assessed using STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. The iBCFS rate at 3 years will be assessed.

Time frame
At 3 years

Secondary outcomes

1

Incidence and severity of adverse events (AEs) using CTCAE v4.03

To evaluate Safety of ribociclib + ET

Time frame
Up to approximately 6 years
2

Invasive Disease-Free Survival (iDFS)

iDFS is defined as the time from the date of first dose of study treatment to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed using STEEP 2.0 as assessed by the investigator.

Time frame
Up to approximately 6 years
3

Distant Disease-Free Survival (DDFS)

Distant Disease-Free Survival (DDFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site, death (any cause), or second primary non-breast invasive cancer (excluding in situ/non-invasive cancers and basal and squamous cell carcinomas of the skin). DDFS will be assessed using STEEP 2.0 as assessed by the investigator.

Time frame
Up to approximately 6 years
4

Distant Relapse-Free Survival (DRFS)

Distant Relapse Free Survival (DRFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site or death (any cause). DRFS will be assessed using STEEP 2.0 as assessed by the investigator.

Time frame
Up to approximately 6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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