BridgeMD
New treatment option for Locoregional Recurrence
Official title Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
ClinicalTrials.gov ID: NCT05467891
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 locoregional recurrence.
Also referred to as Kisqali.
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
- This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligibility Criteria to Collect Optional Correlative Blood and Tissue at Local Recurrence
- Written informed consent (stage I) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific...
- Male or female age ≥ 18 years at the time of consent.
- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast...
- Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in...
You likely can't join if
- for Treatment Phase: people meeting any of the criteria below may not participate in the study:
- Patient with a known hypersensitivity to any of the excipients of ribociclib.
- Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may...
- Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
- Pregnant or breastfeeding or planning to become pregnant during the trial (NOTE: breast milk cannot be stored for future use while the mother is...
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works...
See the full eligibility criteria
Who can join
- Eligibility Criteria to Collect Optional Correlative Blood and Tissue at Local Recurrence
- Written informed consent (stage I) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific procedures. NOTE: HIPAA authorization may be included in the informed...
- Male or female age ≥ 18 years at the time of consent.
- Patient 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 and all tested by...
- Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an 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...
- Patient has locoregional recurrence of breast cancer: locoregional recurrence is defined as invasive recurrence in the ipsilateral breast, axilla, regional nodes, or chest wall. for Treatment Phase: Subject must meet...
- Written informed consent (stage II/ main consent) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures. NOTE: HIPAA authorization may be...
- Male or female age ≥ 18 years at the time of consent. NOTE: Both pre- and post-menopausal women are eligible. Post-menopausal status is defined as:
- Prior bilateral oophorectomy
- Age ≥60
- Age \<60 and amenorrhea for the last 12 or more months(in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range.
- ECOG Performance Status of 0-1 within 28 days prior to registration.
- If patient is receiving tamoxifen or toremifene, a washout period of 5 half-lives (i.e. 35 days) prior to registration is required (during that period the participant can take AI).
- Patient 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 and all tested by...
- Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an 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...
- Patients have had adequate local treatment for locoregional recurrence (LRR) of breast cancer.
- Locoregional recurrence is defined as recurrence in the ipsilateral breast, axilla, regional lymph nodes, or chest wall.
- Local treatment is defined as either surgery, radiation therapy, or a combination of both if indicated.
- Adequate local therapy is surgery with negative microscopic margins. Radiation therapy is mandated for patients with microscopically involved margins and recommended for all patients who had not received radiotherapy as...
- Patients who have distant metastatic disease will not be eligible.
- Prior treatment with neoadjuvant and adjuvant chemotherapy and ET is allowed.
- Patients must enroll within 6 months of the last local treatment, either local surgery or radiation; or systemic chemotherapy (if patient is receiving chemotherapy), whichever occurred last. Chemotherapy after local...
- Patient has no contraindication to the adjuvant ET in the trial and is planned to be treated or continue treatment with ET.
- Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
- Hematological
- Absolute Neutrophil Count (ANC): ≥ 1.5 x 109/L
- Platelets: ≥ 100 x 109/L
- Hemoglobin (Hgb): ≥ 9.0 g/dL
- Renal ---Estimated glomerular filtration rate (eGFR): ≥ 30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula
- Hepatic
- Bilirubin: ≤ upper limit of normal (ULN) except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN
- Aspartate aminotransferase (AST): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the AST is \< 5 × ULN
- Alanine aminotransferase (ALT): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the ALT is \< 5 × ULN
- Coagulation ---International Normalized Ratio (INR) : ≤ 1.5 × ULN (unless is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to the first...
- Electrolytes ---Potassium, Magnesium, and Total Calcium (corrected for serum albumin): Within normal limits or corrected to within normal limits with supplements.
- Standard 12-lead ECG values defined as
- QTcF interval at screening \< 450 msec (QT interval using Fridericia's correction)
- Resting heart rate 50-90 bpm (determined from the ECG)
- Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration and must be willing to use a highly...
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
- Ability to swallow and retain oral medication.
What rules you out
- for Treatment Phase: people meeting any of the criteria below may not participate in the study:
- Patient with a known hypersensitivity to any of the excipients of ribociclib.
- Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to...
- Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
- Pregnant or breastfeeding or planning to become pregnant during the trial (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen are not eligible for this...
- Patients with distant metastases of breast cancer beyond regional lymph nodes as defined by AJCC (8th edition).
- Treatment with any investigational drug within 30 days prior to registration or participation in any other type of medical research judged not to be scientifically or medically compatible with this study. Enrollment or...
- Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea...
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or...
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
- History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry
- Documented cardiomyopathy
- History of Left Ventricular Ejection Fraction (LVEF) \< 50%
- Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- Risk factors for Torsades de Pointe (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
- Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days...
- Inability to determine the QTcF interval
- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block)
- Systolic Blood Pressure (SBP) \>160 or \<90 mmHg
- Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:
- Concomitant medications, herbal supplements, and/or fruits (e.g., grapefruit, pummelos, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4/5,
- Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
- Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. Note: The following uses of...
- Patient with an uncontrolled psychiatric condition that, in the investigator's judgment, may cause unacceptable safety risks, impede research integrity and compliance, or interfere with the objectives of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Washington D.C., District of Columbia, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Fort Wayne, Indiana, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Wyoming, Michigan, United States
- Omaha, Nebraska, United States
- New Brunswick, New Jersey, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Hershey, Pennsylvania, United States
- Charleston, South Carolina, United States
- Charlottesville, Virginia, United States
- Richmond, Virginia, United States
+ 1 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Washington D.C., District of Columbia, United States; Orlando, Florida, United States; Chicago, Illinois, United States; Fort Wayne, Indiana, United States and 15 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.