NCT05827081 Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
| NCT ID | NCT05827081 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Early Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2029-09-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,400 participants in total. It began in 2024-02-28 with a primary completion date of 2029-09-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Key Inclusion criteria: * 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. * For participants with prior ET treatment \> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment. * 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. * Participant has no contraindication to receive adjuvant ET in the study. * Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories: * Anatomic Stage Group III, or * Anatomic Stage Group IIB, or * A subset of Anatomic Stage Group IIA. * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2. * Participant has adequate bone marrow and organ function. * 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). Key Exclusion criteria: * 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. * Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial. * Women of child-bearing potential (CBP), 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. Other inclusion/exclusion criteria may apply
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT05827081 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Early Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05827081 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,400 participants.
Is NCT05827081 currently recruiting?
Yes, NCT05827081 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT05827081 trial being conducted?
This trial is being conducted at Birmingham, United States, Anchorage, United States, Goodyear, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT05827081 clinical trial?
NCT05827081 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 1,400 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.