A trial to learn more about the effects of ribociclib taken with endocrine therapy in patients with early breast cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Jul 2025 → ongoing

Decision date (initial)

2025-06-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

External identifiers

EU CT number

2022-503001-38-01

ClinicalTrials.gov

NCT05827081

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

To evaluate invasive Breast Cancer Free Survival (iBCFS) rate at 3-years for ribociclib + endocrine therapy (ET) in patients with HR-positive, HER2-negative early breast cancer.

Secondary objectives 9

1. To evaluate Safety of ribociclib + ET.
2. To evaluate invasive Disease Free Survival (iDFS) for ribociclib + ET.
3. To evaluate Distant Relapse-Free Survival (DRFS) for ribociclib + ET
4. To evaluate Recurrence-Free Interval (RFI) for ribociclib + ET
5. To evaluate relative dose intensity of ribociclib
6. To evaluate Overall Survival (OS)
7. To evaluate discontinuation rates of ribociclib
8. To evaluate Quality of Life (QoL) by patient reported outcomes (PROs) for ribociclib + ET
9. To evaluate Distant Disease-Free Survival (DDFS) for ribociclib + ET.

Conditions and MedDRA coding

HR-positive HER-2- negative Breast Cancer

Regulatory references

Plan to share IPD

Yes

IPD plan description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Participant is an adult, male or female ≥ 18 years of age at the time of informed consent signature (ICF).
2. 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 and all tested by a local laboratory prior to enrolment.
3. 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.
4. Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrolment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy. For participants with prior ET treatment >12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrolment. The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.
5. Participant has no contraindication to receive adjuvant ET in the study.
6. Participant after surgical resection where tumour was removed completely, with the final surgical specimen microscopic margins free from tumour, and belongs to one of the following categories: anatomic stage group III and substets of anatomic stage group II.
7. Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2.
8. Participant has adequate bone marrow and organ function.
9. ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as: • QTcF interval at screening < 450 msec (QT interval using Fridericia’s correction). • Mean resting heart rate 50-99 beats per minute (determined from the ECG ).

Exclusion criteria 6

1. Participant with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
2. Participant is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET.
3. Participant has any other concurrent severe and/or uncontrolled medical condition
4. - Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
5. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. iBCFS using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant Breast Cancer Clinical Trials), as assessed by Investigator

Secondary endpoints 9

1. Incidence and severity of adverse events (AEs) using CTCAE v4.03
2. iDFS utilisant les critères STEEP version 2.0
3. DRFS using STEEP Version 2.0 criteria
4. RFI using STEEP Version 2.0 criteria
5. Relative Dose Intensity (RDI)
6. Overall survival (OS) defined as from the start of treatment to date of death due to any cause.
7. Time to discontinuation (TTD) of ribociclib
8. Changes from Baseline in FACT-B, FACT-ES, FACIT-F, EQ-5D-5L and WPAI-GH PRO questionnaires
9. DDFS using STEEP Version 2.0 criteria

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel Town

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 5

Locations

2 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 31 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications