Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy (NCT05069038) | Clinical Trial Compass
Active ā Not RecruitingPhase 2
Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy
United States51 participantsStarted 2022-03-02
Plain-language 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.
Who can participate
Age range19 Years
SexFEMALE
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Inclusion criteria
ā. Histologically confirmed locally advanced stage ER+ and/or PR+ and HER2- breast cancer \[by ASCO/CAP guidelines: primary tumor size 2 cm or greater OR if primary tumor size is \<2 cm with lymph node involvement (Stage II)\] who are candidates for palbociclib in combination with concurrent ovarian suppression and letrozole per treating physician.
ā. At least 19 years of age.
ā. ECOG performance status ā¤ 2 (see Appendix A)
ā. Normal bone marrow and organ function as defined below:
ā. Absolute neutrophil count ā„ 1,500/mcl
ā. Platelets ā„ 100,000/mcl
ā. Total bilirubin ā¤ IULN or total bilirubin ā¤ 3.0 x IULN with direct bilirubin within normal range in subjects with documented Gilbert's syndrome
ā. AST(SGOT)/ALT(SGPT) ā¤ 1.5 x IULN (up to 5 x IULN in subjects with liver disease)
Exclusion criteria
ā. Prior therapy with any CDK inhibitor.
What they're measuring
1
Overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy
ā. Currently receiving any other investigational agents.
ā. Currently receiving exogenous hormone therapy (topical vaginal estrogen therapy is allowed).
ā. Known metastatic disease
ā. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in the study.
ā. Receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days prior to registration.
ā. Clinically significant history of liver disease as defined by active hepatitis and/or cirrhosis with compromised liver function.
ā. A condition that would interfere with enteric absorption.