Breast Cancer Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | September 1, 2031 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years and older |
Eligibility | Inclusion 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). Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United States | Unversity of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy | 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 | 6 Months | |
Primary | Rate of reduction of Ki67 index | To determine the rate of reduction of Ki67 index after 4 weeks of neoadjuvant Palbociclib and endocrine therapy | 4 Weeks | |
Secondary | Rate of grade 3 or higher neutropenia | To determine the rate of grade 3 or higher neutropenia in cycle 1 and all cycles | 6 Months | |
Secondary | Clinical benefit rate with neoadjuvant palbociclib in combination with endocrine therapy | To determine the clinical benefit rate (CR+PR+SD) with neoadjuvant palbociclib in combination with endocrine therapy in subjects with hormone receptor positive and Her-2/neu negative breast cancer | 6 Months | |
Secondary | Tumor down staging rate | To determine the tumor down staging rate as measured by number of positive lymph nodes with neoadjuvant palbociclib in combination with endocrine therapy in subjects with hormone receptor positive and Her-2/neu negative breast cancer | 6 Months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |