No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Mridula George, MD · Other
Who this trial is looking for
This trial is looking for women with a specific type of breast cancer who are planning to have surgery. Participants will receive radiation therapy along with two medications called Abemaciclib and Letrozole before their surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with hormone receptor positive breast cancer.
I have a tumor that is at least 1.5 cm in size.
I am post-menopausal.
I do not have signs of cancer that has spread.
I am able to have surgery for my breast cancer.
I can swallow pills.
I have adequate organ function.
My cancer is HR positive and HER2 negative.
You may not be able to join if
I have had breast cancer before.
I have been treated with similar medications before.
I have had radiation to my chest or breast before.
I need chemotherapy before surgery.
I have cancer that has spread to other parts of my body.
I have serious high blood pressure.
I have a life expectancy of less than 12 weeks.
I have any serious medical conditions or allergies to the study drugs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to assess the benefits of concurrent use of these treatments in a specific participant population, focusing on their safety and tolerability.…
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to assess the benefits of concurrent use of these treatments in a specific participant population, focusing on their safety and tolerability. The hypothesis is that the combination therapy will be well-tolerated, providing valuable insights into its effectiveness for future clinical applications.
Trial Locations
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Status
Eligibility Criteria
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 …
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
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