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New treatment option for Early Breast Cancer
Official title Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
ClinicalTrials.gov ID: NCT05827081
What this study is testing
What is Ribociclib?
Ribociclib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for early breast cancer.
Also referred to as LEE011.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- 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...
- Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent...
- For participants with prior ET treatment \> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out...
You likely can't join if
- Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after...
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Goodyear, Arizona, United States
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- Cerritos, California, United States
- Duarte, California, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- Mountain View, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Altamonte Springs, Florida, United States
- Fort Lauderdale, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Jupiter, Florida, United States
+ 177 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Goodyear, Arizona, United States; Little Rock, Arkansas, United States; Beverly Hills, California, United States; Cerritos, California, United States and 191 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.