ACTIVE_NOT_RECRUITING

Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy

Conditions

Breast Cancer estrogen receptor positive progesterone receptor positive neo-adjuvant

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-02

Study Completion:2032-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05069038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. At least 19 years of age. 3. ECOG performance status ≤ 2 (see Appendix A) 4. Normal bone marrow and organ function as defined below: 1. Absolute neutrophil count ≥ 1,500/mcl 2. Platelets ≥ 100,000/mcl 3. Total bilirubin ≤ IULN or total bilirubin ≤ 3.0 x IULN with direct bilirubin within normal range in subjects with documented Gilbert's syndrome 4. AST(SGOT)/ALT(SGPT) ≤ 1.5 x IULN (up to 5 x IULN in subjects with liver disease) 5. Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels above institutional normal 5. Pre-menopausal subjects defined by: Age \<60 with no prior bilateral oophorectomy and having menses in the preceding 12 months in the absence of taking chemotherapy, tamoxifen or torimefene or ovarian suppression. If any of these agents were used, measurements of FSH and estradiol have to be made to determine menopausal status. 6. Post menopausal subjects defined by: Age \>60 Or absence of menstruation in the preceding 12 months without taking chemotherapy, tamoxifen, torimefene or ovarian suppression. If any of these agents were used, measurements of FSH and estradiol have to be made to determine menopausal status. If none of these are applicable fully, subject may be judged premenopausal according to local policies. 7. Participating subjects must agree to use adequate contraception for the duration of protocol treatment and for 6 months after the last treatment with palbociclib. Adequate contraception is defined as one highly effective form (i.e. abstinence, (fe)male sterilization OR two effective forms (e.g. non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository). Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. 8. Able to swallow and retain oral medication. 9. Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).	1. Prior therapy with any CDK inhibitor. 2. Currently receiving any other investigational agents. 3. Currently receiving exogenous hormone therapy (topical vaginal estrogen therapy is allowed). 4. Known metastatic disease 5. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in the study. 6. Receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days prior to registration. 7. Clinically significant history of liver disease as defined by active hepatitis and/or cirrhosis with compromised liver function. 8. A condition that would interfere with enteric absorption. 9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. 10. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry. 11. Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with palbociclib. In addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy. 12. Male Sex

Inclusion Criteria

Exclusion Criteria

1. 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.
2. At least 19 years of age.
3. ECOG performance status ≤ 2 (see Appendix A)
4. Normal bone marrow and organ function as defined below:
1. Absolute neutrophil count ≥ 1,500/mcl
2. Platelets ≥ 100,000/mcl
3. Total bilirubin ≤ IULN or total bilirubin ≤ 3.0 x IULN with direct bilirubin within normal range in subjects with documented Gilbert's syndrome
4. AST(SGOT)/ALT(SGPT) ≤ 1.5 x IULN (up to 5 x IULN in subjects with liver disease)
5. Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for subjects with serum creatinine levels above institutional normal
5. Pre-menopausal subjects defined by: Age \<60 with no prior bilateral oophorectomy and having menses in the preceding 12 months in the absence of taking chemotherapy, tamoxifen or torimefene or ovarian suppression. If any of these agents were used, measurements of FSH and estradiol have to be made to determine menopausal status.
6. Post menopausal subjects defined by: Age \>60 Or absence of menstruation in the preceding 12 months without taking chemotherapy, tamoxifen, torimefene or ovarian suppression. If any of these agents were used, measurements of FSH and estradiol have to be made to determine menopausal status. If none of these are applicable fully, subject may be judged premenopausal according to local policies.
7. Participating subjects must agree to use adequate contraception for the duration of protocol treatment and for 6 months after the last treatment with palbociclib. Adequate contraception is defined as one highly effective form (i.e. abstinence, (fe)male sterilization OR two effective forms (e.g. non-hormonal IUD and condom / occlusive cap with spermicidal foam / gel / film / cream / suppository). Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
8. Able to swallow and retain oral medication.
9. Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

1. Prior therapy with any CDK inhibitor.
2. Currently receiving any other investigational agents.
3. Currently receiving exogenous hormone therapy (topical vaginal estrogen therapy is allowed).
4. Known metastatic disease
5. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in the study.
6. Receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days prior to registration.
7. Clinically significant history of liver disease as defined by active hepatitis and/or cirrhosis with compromised liver function.
8. A condition that would interfere with enteric absorption.
9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
10. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry.
11. Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with palbociclib. In addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy.
12. Male Sex

Contacts and Locations

Principal Investigator

Amulya Yellala, MBBS

PRINCIPAL_INVESTIGATOR

University of Nebraska

Study Locations (Sites)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Collaborators and Investigators

Sponsor: University of Nebraska

Amulya Yellala, MBBS, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-02

Study Completion Date2032-09

Study Record Updates

Study Start Date2022-03-02

Study Completion Date2032-09

Terms related to this study

Keywords Provided by Researchers

estrogen receptor positive
progesterone receptor positive
neo-adjuvant

Additional Relevant MeSH Terms

Breast Cancer