Breast Cancer study: Abemaciclib vs Letrozole
Official title RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
ClinicalTrials.gov ID: NCT06139107
What this study is testing
What is Abemaciclib?
An investigational oral CDK4/6 inhibitor being studied as a potential treatment for hormone‑receptor‑positive/HER2‑negative breast cancer combined with pre‑operative radiation. is designed to block cyclin‑dependent kinases 4 and 6, which helps stop cancer cells from dividing.
Also referred to as Verzenio.
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 study is testing whether giving radiation before surgery together with two medicines is safe and tolerable for people with hormone‑positive, HER2‑negative breast cancer.
- Who it's for
- You may be able to join if you have hormone‑positive, HER2‑negative breast cancer and are scheduled for surgery.
- What's involved
- You will receive radiation treatment before your surgery and take two medicines at the same time. You will have regular check‑ins to monitor safety.
- Time commitment
- The study lasts until your surgery and a short follow‑up period, with a few visits for safety checks.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older, women only
You may be able to join if
- Histologically and/or cytologically confirmed diagnosis of invasive (ductal, lobular or mixed histology), Clinically inapparent tumor that is not...
- Expression of ER or progesterone receptors (PR)and negative expression of HER2 per American Society of Clinical Oncology, (ASCO) Common Alerting...
- Oncotype diagnosis (DX) Breast Recurrence score of less than 25 on core biopsy specimen
- age \<60 with amenorrhea for at least 12 months in the absence of prior chemotherapy, tamoxifen, toremifene, or ovarian suppression and estradiol and...
- No clinical suspicion of metastasis disease
You likely can't join if
- History of ipsilateral breast cancer
- Prior treatment with CDK4/6 inhibitors or aromatase inhibitors
- History of chest wall or ipsilateral breast radiation
- Inflammatory breast cancer
- Needs neoadjuvant chemotherapy
- Presence of distant metastatic disease
See the full eligibility criteria
- Histologically and/or cytologically confirmed diagnosis of invasive (ductal, lobular or mixed histology), Clinically inapparent tumor that is not palpable. (cT1-T2N0)disease. Minimum tumor size of 1.5 cm
- Expression of ER or progesterone receptors (PR)and negative expression of HER2 per American Society of Clinical Oncology, (ASCO) Common Alerting Protocol (CAP) guidelines
- Oncotype diagnosis (DX) Breast Recurrence score of less than 25 on core biopsy specimen
- age \<60 with amenorrhea for at least 12 months in the absence of prior chemotherapy, tamoxifen, toremifene, or ovarian suppression and estradiol and FSH (follicle stimulating hormone) in postmenopausal range.
- No clinical suspicion of metastasis disease
- Eastern Cooperative Oncology Group (ECOG) performance status of follicle stimulating hormone (PFS) ≤2
- Eligible to undergo surgery, either lumpectomy or mastectomy for local treatment of the breast cancer
- Able to swallow oral medications
- Adequate organ function for all of the following: Absolute Neutrophil (ANC) \>1.5 x 10/L Platelets \>100 x 10/L Hemoglobin \>8 g/dL - May receive erythrocyte transfusions to achieve this level Total Bilirubin \<1.5 x...
- HR positive/HER2 -negative breast cancers are allowed as long as no other exclusions exist
- History of ipsilateral breast cancer
- Prior treatment with CDK4/6 inhibitors or aromatase inhibitors
- History of chest wall or ipsilateral breast radiation
- Inflammatory breast cancer
- Needs neoadjuvant chemotherapy
- Presence of distant metastatic disease
- Contraindication for surgery
- Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg)
- Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
- Life expectancy \< 12 weeks
- History of allergy or hypersensitivity to any of the study drugs
- Any significant medical condition, laboratory abnormality, or psychiatric illness
- Serious and/or uncontrolled preexisting medical condition
- Has had major surgery within 14 days prior to enrollment
- Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently enrolled in any other type of medical research
- Has active systemic bacterial infection
- Personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular...
The study team makes the final eligibility decision.
Where it is enrolling
- Belleville, New Jersey, United States
- Livingston, New Jersey, United States
- New Brunswick, New Jersey, United States
- Somerville, New Jersey, 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, but 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 female, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Belleville, New Jersey, United States; Livingston, New Jersey, United States; New Brunswick, New Jersey, United States; Somerville, New Jersey, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.