Spots Global Cancer Trial Database for Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy

Study Description

Brief Summary: 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.

Detailed Description: Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with neo-adjuvant chemotherapy. The sensitivity of breast cancer to chemotherapy is often determined by the underlying gene expression pattern and the molecular subtype of the tumor. The luminal subtype (A/B) which includes most of the ER+ tumors are less sensitive to chemotherapy with lower pathologic complete responses compared to ER- tumors. In addition, not all patients tolerate chemotherapy well. Due to these factors, pre-operative endocrine therapy emerged as an effective strategy to improve outcomes in patients with early stage hormone receptor positive breast cancer. Palbociclib, an oral CDK 4/6 inhibitor in combination with anastrazole was recently shown to achieve cell cycle arrest (defined as Ki-67 \<2.7%) at cycle 1, day 15 in 85% of the studied population. This supports the evaluation of this combination further in the neo-adjuvant and adjuvant settings. Hence, this study proposes to 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.

Keywords

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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