A Phase II Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy for Post and Pre-menopausal Patients With Early Stage Hormone Receptor Positive and Her-2/Neu Negative Breast Cancer

NCT05069038 Phase 2 ACTIVE_NOT_RECRUITING

Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with pre-operative chemotherapy. The sensitivity of breast cancer to chemotherapy is often determined by the underlying gene expression pattern and the molecular subtype of the tumor. In addition, not all patients tolerate chemotherapy well. Pre-operative endocrine therapy has emerged as an effective strategy to improve outcomes in patients with early-stage hormone receptor positive breast cancer. This study will assess the role of neo-adjuvant palbociclib (CDK 4/6 inhibitor) in combination with letrozole (aromatase inhibitor) +/-Goserelin (GnRH analogue) to improve overall response and surgical feasibility in post and pre-menopausal hormone receptor positive and Her-2 negative subjects with stage IIA-IIIC breast cancer.

Details

Lead sponsor	University of Nebraska
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	51
Start date	2022-03-02
Completion	2032-09

Conditions

• Breast Cancer

Interventions

• Palbociclib 125mg

Primary outcomes

• Overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy — 6 Months
  To determine the overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy in subjects with hormone receptor positive and Her-2/neu negative breast cancer
• Rate of reduction of Ki67 index — 4 Weeks
  To determine the rate of reduction of Ki67 index after 4 weeks of neoadjuvant Palbociclib and endocrine therapy

Countries

United States