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Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

1400 patients around the world

Available in United States, Mexico

The study consists of Screening, Treatment, and Follow-up periods. - Treatment Period: all participants who complete screening will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily ET for 36 months (approximately 39 cycles) from the date of first dose. The Treatment Period starts when the patient receives their first dose of ribociclib and ends at the time of the 30-day Safety Follow-up. All treated participants should have a Safety Follow-up call conducted 30 days after the last dose of study treatment. - Follow-up period: participants will be followed from 30 days after study treatment (i.e., ribociclib) completion/discontinuation (i.e. 30-day Safety Follow-up) until death, withdrawal of consent, lost to follow-up, or until 48 months after the last participant has received their first dose of study treatment (i.e. End of Study [EOS]), whichever occurs first.

Novartis Pharmaceuticals

1400Patients around the world

This study is for people with

Breast Cancer

Requirements for the patient

To 100 Years

All Gender

Medical requirements

: Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature.
Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.
Participant has HER2- breast cancer defined as a negative in situ hybridization test or an immunohistochemistry status of 0, 1+ or 2+.
If IHC is 2+, a negative in situ hybridization 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 endocrine therapy, including tamoxifen or toremifene at the time of informed consent signature.
Enrollment should occur within 36 months of prior endocrine therapy start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.
For participants with prior endocrine therapy treatment greater than 12 months, restaging is highly recommended to rule out disease recurrence prior to enrollment.
The number of participants with prior endocrine therapy 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 endocrine therapy 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.
Anatomic Stage Group IIB.
A subset of Anatomic Stage Group IIA.
Participant has an Eastern Cooperative Oncology Group 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 follows:
QTcF interval at Screening less than 450 msec.
Mean resting heart rate 50-99 beats per minute determined from the ECG.

: Participant with distant metastases of breast cancer beyond regional lymph nodes and/or evidence of recurrence after curative surgery.
Participant is concurrently using other antineoplastic therapy with the exception of adjuvant endocrine therapy.
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 less than or equal to 5 years.
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
Pregnant or breast-feeding women or women who plan to become pregnant or breast-feed during the trial.
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.

StudyAdjuvant WIDER

SponsorNovartis Pharmaceuticals

Study typeInterventional

Conditions

Breast Cancer

Requirements

To 100 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05827081