Study on the Safety of Palbociclib with Hormone Therapy Before Surgery for Breast Cancer

Sponsor: University of Nebraska

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05069038

Provider View

This clinical trial is exploring the use of palbociclib, a medication combined with hormone therapy, to improve treatment outcomes for patients with hormone receptor-positive breast cancer before surgery.

Patient Parameters

Program Overview

This study is investigating whether using palbociclib, a drug that targets specific cancer cell growth, along with hormone therapy, can help improve treatment results for patients with early-stage hormone receptor-positive breast cancer. The focus is on patients whose cancer is positive for estrogen or progesterone receptors but negative for HER-2. The trial aims to see if this combination can make surgery more effective and improve overall response to treatment.

Description

Patients with certain types of breast cancer, specifically those that are positive for estrogen or progesterone receptors, often do not respond well to chemotherapy before surgery. This is because the cancer's response to chemotherapy can depend on its genetic makeup and type. Many patients also find chemotherapy difficult to tolerate. As a result, using hormone therapy before surgery has become a promising approach to improve outcomes for these patients.

Palbociclib is a medication that works by stopping cancer cells from growing. When used with hormone therapy drugs like letrozole, and sometimes goserelin, it has shown potential in stopping cancer cell growth early in treatment. This study will test if this combination can improve the chances of successful surgery and better overall treatment results for patients with hormone receptor-positive, HER-2 negative breast cancer at stages IIA to IIIC.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with locally advanced breast cancer that is positive for estrogen or progesterone receptors and negative for HER-2, with a tumor size of 2 cm or larger, or smaller tumors with lymph node involvement.
  • At least 19 years old.
  • Good overall health with a performance status score of 0 to 2.
  • Normal blood and organ function, including specific levels for neutrophils, platelets, bilirubin, liver enzymes, and creatinine.
  • For pre-menopausal women: under 60 years old, not had both ovaries removed, and having regular periods unless affected by certain medications.
  • For post-menopausal women: over 60 years old or not having periods for 12 months without certain medications.
  • Agree to use effective birth control during the study and for 6 months after the last dose of palbociclib.
  • Able to swallow pills.
  • Willing to sign a consent form to participate.

Exclusion Criteria

  • Previous treatment with any CDK inhibitor.
  • Currently taking other experimental drugs.
  • Currently on hormone therapy, except for certain vaginal estrogen treatments.
  • Cancer that has spread to other parts of the body.
  • Allergic reactions to similar drugs as palbociclib.
  • Taking medications that affect liver enzymes within 7 days before starting the study.
  • Significant liver disease, such as active hepatitis or cirrhosis.
  • Conditions affecting the absorption of oral medications.
  • Uncontrolled health issues like infections, heart failure, or unstable heart conditions.
  • Pregnant or breastfeeding women. Women of childbearing age must have a negative pregnancy test before joining the study.
  • HIV-positive individuals on antiretroviral therapy due to potential drug interactions and increased infection risk.
  • Male participants.

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