Abemaciclib for Hormone Receptor Positive Breast Cancer

Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib

Recruiting Phase 2 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
60 (estimated)
Sponsor
University of Texas Southwestern Medical Center · Other
Who this trial is looking for

This trial is looking for women with specific types of breast cancer to understand how the immune system can help treat their condition. Participants will receive treatment for two weeks and provide blood and tissue samples for research.

Are You a Good Fit for This Trial?
Must not be taking TamoxifenRaloxifene

You may be able to join if

  • I have been diagnosed with hormone receptor positive breast cancer.
  • I am post-menopausal.
  • I have a breast tumor that is at least 1 cm in size.
  • I am at least 18 years old.
  • I am able to swallow oral medications.
  • I have not had any cancer treatment for my current breast cancer diagnosis.
  • I understand and am willing to sign the consent form.

You may not be able to join if

  • I am currently pregnant or breastfeeding.
  • I have active metastatic or inflammatory breast cancer.
  • I have a serious health condition that my doctor says prevents me from joining this study.
  • I have had chemotherapy or radiation for my breast cancer recently.
  • I am known to be allergic to similar medications.
  • I have uncontrolled health issues like severe infections or heart problems.
  • I have mental health issues that would prevent me from understanding the study.

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.

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About This Trial
The purpose of this study is to better understand how the immune system plays a role in fighting breast cancer and specifically research if the immune system response against breast cancer can be improved with endocrine therapy and cyclin dependent kinase inhibitor therapy in patients with hormone receptor positive breast cancer. This will be studied by collecting tumor tissue and blood samples be…
Trial Locations
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Eligibility Criteria
INCLUSION CRITERIA: * Clinical stage operable stage I, II, or III invasive mammary carcinoma, which is estrogen receptor or progesterone receptor positive by immunohistochemistry and HER2 negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing. * H…
Contacts

Shahbano Shakeel

214-648-7097

Shahbano.Shakeel@UTSouthwestern.edu

CONTACT