Combining pre-operative radiation with Abemaciclib and Letrozole for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1b study investigates the safety and feasibility of using pre-operative radiation therapy alongside CDK4/6 inhibitors in patients with hormone receptor positive/HER2 negative breast cancer. The research focuses on the concurrent administration of these treatments to assess their combined effects and tolerability. Participants will undergo thorough evaluations, including clinical assessments and imaging studies, to monitor treatment responses and any potential side effects. The goal is to gather valuable data that could inform future clinical applications of this combination therapy.

Why it matters

Who can join: the full rules

Inclusion 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
* Post-menopausal status defined:
* 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 Upper Limit of Normal (ULN) Alanine Aminotransferase (ATL) and Aspartate Aminotransferase (AST) \<3 x ULN

* HR positive/HER2 -negative breast cancers are allowed as long as no other exclusions exist

Exclusion Criteria:

* 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 fibrillation), or sudden cardiac arrest

Where it's running

• RWJBarnabas Health Clara Maas Medical Center
  Belleville, New Jersey, United States Recruiting
• Cooperman Barnabas Medical Center
  Livingston, New Jersey, United States Recruiting
• Rutgers Cancer Institute of New Jersey
  New Brunswick, New Jersey, United States Recruiting
• RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
  Somerville, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Mridula A George, MD — Cancer Institute of New Jersey Rutgers
• Study coordinator: Mridula A George, MD
• Email: mridula@cinj.rutgers.edu
• Phone: 732-235-9081

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

• Different skin care approaches to prevent skin reactions after mastectomy radiation

  This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07918989

• 3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy

  This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.

  Recruiting Region Skane · Lund, Skåne County · NCT07916337

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.