Breast Cancer Clinical Trial
Official title:
An Assessment of the Biological and Clinical Effects of Palbociclib (PD 0332991) With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Patients With Premenopausal Estrogen-Receptor Positive/HER2-Negative Primary Breast Cancer
Verified date | April 2022 |
Source | NSABP Foundation Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been treated.
Status | Completed |
Enrollment | 24 |
Est. completion date | January 30, 2021 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must be premenopausal. Patients with a hysterectomy: menopausal status must be confirmed by estradiol and FSH. - Operable hormonal receptor (HR) positive (ER/PR greater than or equal to 10%), HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment and ovarian suppression; HR- positive and HER2-negative as determined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP ) guidelines. - Diagnostic breast tissue must have an Oncotype DX Breast Recurrence Score® of less than 26 as determined by Genomic Health, Inc. - No known severe hypersensitivity reactions to compounds similar to palbociclib or palbociclib excipients or to endocrine treatments. - A breast tumor with an ultrasound size of at least 2.0 cm. - Patients must have the ability to swallow oral medication. - ECOG performance status of 0 or 1. - At the time of randomization, blood counts performed within 2 weeks prior to randomization must meet the following criteria: - ANC must be greater than or equal to 1500/mm3 - Platelet count must be greater than or equal to 100,000/mm3 - Hemoglobin must be greater than or equal to 10g/dL. - INR must be within normal limits of the local laboratory ranges. For laboratories that do not report an ULN for the INR assay, use less than or equal to 1.2 as the value for the ULN. - The following criteria for evidence of adequate hepatic function performed within 2 weeks prior to study entry must be met: - Total bilirubin must be less than or equal to ULN for the lab unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and - Alkaline phosphatase must be must be less than or equal to 1.5 x ULN for the lab; and - AST and ALT must be less than or equal to 1.5 x ULN for the lab. - Serum creatinine performed within 2 weeks prior to study entry must be less than or equal to 1.25 x ULN or estimated creatinine clearance greater than or equal to 60 mL/min (as calculated using the method standard for the institutions). Exclusion Criteria: - Active hepatitis B or hepatitis C with abnormal liver function tests. - HIV positive patients receiving antivirals. - Inflammatory/inoperable breast cancer. - HER2-positive as determined using ASCO-CAP Guidelines. - Oncotype Dx Breast Recurrence Score® result on diagnostic breast tissue greater than or equal to 26. - Prior endocrine therapy for breast cancer. - Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ). - Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up such as: - Active infection or chronic infection requiring chronic suppressive antibiotics; - Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function; - Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids); - Seizure disorders requiring medication. - Diagnosis by fine needle aspiration (FNA) alone or excisional biopsy or lumpectomy performed prior to study entry. - Surgical axillary staging procedure prior to study procedure (with exception of FNA or core biopsy). - Definitive clinical or radiologic evidence of metastatic disease. - History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with radiotherapy or contralateral invasive breast cancer at any time. - Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry. - Use of any medication or substances that are strong inhibitors or inducers of CYP3A isoenzymes. Class III or Class IV myocardial disease as described by the New York Heart Association; a recent history (within 6 months) of myocardial infarction, or symptomatic arrhythmia at the time of randomization. - Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Such patients are comfortable at rest. Less than ordinary physical activity that causes fatigue, palpitation, dyspnea, or anginal pain. - Class IV: Patients with cardiac disease resulting in inability to perform any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. - The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | Jewish General Hospital - Montreal | Montreal | Quebec |
Canada | McGill University Health Centre-Cedars Cancer Centre | Montréal | Quebec |
Canada | CHU de Quebec - Hopital de Saint-Sacrement | Quebec City | Quebec |
United States | Cancer Care Specialists of Central Illinois | Decatur | Illinois |
United States | Breast Cancer Care Specialist | Fountain Valley | California |
United States | Orange Coast Blood and Cancer Care | Fountain Valley | California |
United States | Lester and Sue Smith Breast Center | Houston | Texas |
United States | Saddleback Memorial Medical Center | Laguna Hills | California |
United States | Coast Hematology-Oncology Associates Medical Group | Long Beach | California |
United States | Long Beach Memorial Medical Center | Long Beach | California |
United States | Oncology Hematology Consultants | Long Beach | California |
United States | Froedtert Hospital | Milwaukee | Wisconsin |
United States | West Virginia University | Morgantown | West Virginia |
United States | Avera Cancer Institute-Sioux Falls | Sioux Falls | South Dakota |
Lead Sponsor | Collaborator |
---|---|
NSABP Foundation Inc | Genomic Health®, Inc., Pfizer |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Cell cycle arrest | Percentage of patients with a Ki67 less than 2.7% | From study entry to the time of the 6 week tumor biopsy to assess Ki67, approximately 6 weeks | |
Secondary | Objective response rate | Objective response rate determined by breast tumor assessment measured by clinical exam and ultrasound | From study entry to the 24 week clinical assessment/ultrasound, approximately 24 weeks | |
Secondary | Pathologic complete response to study therapy (breast) | Percentage of patients with absence of invasive cancer in surgical specimens | From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks | |
Secondary | Pathologic complete response to study therapy (breast with nodes) | Percentage of patients with absence of invasive cancer in surgical specimens | From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks | |
Secondary | Correlation between Oncotype DX Breast Recurrence Score® and clinical Complete Response (cCR) | Correlation of the Oncotype DX Breast Recurrence Score® with clinical Complete Response | From study entry to the 24 week clinical assessment/ultrasound, approximately 24 weeks | |
Secondary | Correlation between Oncotype DX Breast Recurrence Score® and pathologic Complete Response (pCR) | Correlation of the Oncotype DX Breast Recurrence Score® with pathologic Complete Response | From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks | |
Secondary | Correlation between Oncotype DX Breast Recurrence Score® and Complete Cell cycle arrest rate (CCAR) | Correlation of the Oncotype DX Breast Recurrence Score® with Complete Cell cycle arrest rate | From the time of study entry to time of the 6-week tumor biopsy to assess Ki67, approximately 6 weeks | |
Secondary | Comparison between surgical intent and surgery received | Changes between surgical intent declared at study start and actual surgery received after treatment | From study entry to time of surgery, generally 3 to 4 weeks after completion of study therapy at approximately 28 weeks | |
Secondary | Comparison of estrone levels | Compare the estrone level at baseline to that after neoadjuvant treatment | From study entry to the 4 week blood draw, approximately 4 weeks | |
Secondary | Comparison of estradiol levels | Compare the estradiol level after neoadjuvant treatment | From study entry to the 4 week blood draw, approximately 4 weeks |
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 |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
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 |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
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 |