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New treatment option for HER2 Negative Breast Cancer
Official title Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
ClinicalTrials.gov ID: NCT06953882
What this study is testing
What is Ribociclib 400mg?
Ribociclib 400mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for her2 negative breast cancer.
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 a Phase II, two-arm, single center, patient preference study designed to evaluate the impact of omitting adjuvant chemotherapy in moderate to high-anatomical risk, low-genomic risk (men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and RS 26-30, or T1-3N1 and RS 26-30, or T1-3N2 and RS ≤ 25),
- 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
- Female or male age ≥ 18 years old and have the ability to understand and the willingness to sign a written informed consent document.
- Participants may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of...
- Participants may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would...
- Participants underwent a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.
- Participants must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node...
You likely can't join if
- Participants who meet any of the following criteria will be excluded from study entry:
- Definitive clinical or radiologic evidence of distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th...
- T4 tumors, including inflammatory breast cancer.
- N3 tumors.
- Participants that have received neoadjuvant chemotherapy or biotherapy.
- Participant is concurrently using hormone replacement therapy.
See the full eligibility criteria
Who can join
- Female or male age ≥ 18 years old and have the ability to understand and the willingness to sign a written informed consent document.
- Participants may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
- Participants may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
- Participants underwent a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.
- Participants must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).
- The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and RS 26-30...
- The tumor must be ER-positive (≥ 10%), HER2-negative, by current ASCO/CAP guidelines based on testing results. HER2-negative breast cancer is defined as a negative in situ hybridization test or an immunohistochemistry...
- Participants with known menopausal status at the time of screen. a. Postmenopausal status is defined as: i. Participant underwent bilateral oophorectomy, or ii. Age ≥ 60 years, or Age \< 60 years and amenorrhea for 12...
- HIV-infected participants with undetectable viral load within 6 months and in long term anti-retroviral therapy that would not have a significant drug-drug interaction with ribociclib are eligible for this trial.
- Radiation therapy should be used according to standard guidelines.
- Participants must have an ECOG performance status of 0 to 1 within 28 days prior to registration of the study.
- Participant is able to swallow oral medications.
- Participants must have adequate organ and marrow function as defined below. All laboratory values must be obtained within 28 days prior to registration of the study.
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
- Platelets ≥ 100 × 109/L.
- Hemoglobin ≥ 9.0 g/dL.
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula.
- Alanine transaminase (ALT) \< 2.5 × Upper Limit Normal (ULN).
- Aspartate transaminase (AST) \< 2.5 × ULN.
- Total serum bilirubin \< ULN; or total bilirubin ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN in patients with well documented Gilbert's Syndrome.
- Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements (the local laboratory value should be documented within normal limits after the correction)...
- Potassium.
- Magnesium.
- Total Calcium (corrected for serum albumin).
- Standard 12-lead ECG values assessed as: QTcF interval (using Fridericia's correction) at screening \< 450 msec. Resting heart rate 50-90 beats per minute (determined from the ECG).
- Participant must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
- Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and within three months after receiving the last dose of the treatment drugs. a. General requirements: i...
- Participant has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for five years or more.
What rules you out
- Participants who meet any of the following criteria will be excluded from study entry:
- Definitive clinical or radiologic evidence of distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- T4 tumors, including inflammatory breast cancer.
- N3 tumors.
- Participants that have received neoadjuvant chemotherapy or biotherapy.
- Participant is concurrently using hormone replacement therapy.
- Participants with a known hypersensitivity to any of the excipients of ribociclib and/or ET (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy...
- Participant has received any CDK4/6 inhibitor.
- Participant has a concurrent invasive malignancy or a prior invasive malignancy that requires systemic therapy or place them at more than minimal risk of mortality in the next 5 years.
- Participant has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (testing is not mandatory, unless required by local regulation).
- Life expectancy of \<5 years due to co-morbid conditions in the opinion of the treating investigator.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Hormonally based contraceptive measures must be discontinued prior to registration (including progestin/progesterone IUDs).
- Pregnancy or lactating women or women who plan to become pregnant or breast-feed during the trial. a. Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed at...
- 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 within six months prior to screening
- Documented cardiomyopathy
- Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia...
- Participant is currently receiving any of the following substances within 7 days before registration:
- Concomitant medications, herbal supplements, and/or fruits (e.g. grapefruit, pummelos, starfruit, Seville oranges) and their juices that are known as strong inhibitors or inducers of CYP3A4/5.
- Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
- Participant is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment or has not fully recovered from side effects of such treatment. Note: The following uses of...
- Participant has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments (e.g. uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea...
- Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the principal investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the...
- Participation in other studies involving investigational drug(s) within 30 days prior to registration or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
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 New Haven, Connecticut, United States. 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.