The investigators propose to influence estrogen receptor (ER) signaling by combining
endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal
growth factor receptor 2 (HER2)+ early stage breast cancer.
Procedure: Breast surgery
Procedure: Research tumor biopsy
Procedure: Research bone marrow (OPTIONAL)
Procedure: Research blood sample
Genetic: Research blood for germline DNA
Procedure: Blood for detection of circulating tumor cells
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Locations near you
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Full eligibility criteria for NCT02907918
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal, staging criteria is to be based on AJCC 7.
Tumor size at least 2 cm in one dimension by clinical or radiographic exam (World Health Organization (WHO) criteria). Patients with histologically confirmed palpable lymph nodes may be enrolled regardless of breast tumor size. A palpable mass is not required as long as the mass is at least 2 cm in one dimension by radiographic exam.
At least 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Normal bone marrow and organ function as defined below:
Leukocytes ≥ 3,000/mcL
Absolute neutrophil count ≥ 1,500/mcl
Platelets ≥ 100,000/mcl
Total bilirubin ≤ institutional upper limit of normal (IULN)
AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Left ventricular ejection fraction (LVEF) ≥ 50% by transthoracic echocardiogram or multigated acquisition scan (MUGA)
Baseline corrected QT interval (QTcF) < 480 ms
Women of childbearing potential must agree to undergo pregnancy testing within 14 days of study entry and agree to use adequate contraception (barrier method of birth control, abstinence, not hormonal) prior to study entry and for the duration of study participation as well as chemical LHRH Agonist with goserelin. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Prior systemic therapy for indexed breast cancer.
Indeterminate or negative HER2 status.
Inflammatory breast cancer.
A history of other malignancy ≤ 5 years from diagnosis of indexed BC with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.
Currently receiving any other investigational agents or received any within the past 28 days.
Know to be HIV positive.
Known hepatitis B or C infection.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib, letrozole, trastuzumab, any other aromatase inhibitor, any other monoclonal antibody, or other agents used in the study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine) or inducers (i.e. dexamethasone, glucocorticoids, progesterone, rifampin, phenobarbital, St. John's wort).
Any condition that impairs the ability to swallow or absorb oral medication (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affective absorption).
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
All locations for NCT02907918
United States (3)
Phoenix, Arizona, United States, 85054
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
View full eligibility
Tris trial is registered with FDA with number: NCT02907918. The sponsor of the trial is Washington University School of Medicine and it is looking for 26 volunteers for the current phase.
Official trial title: A Phase II Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab as Neoadjuvant Treatment of Stage II-III ER+ HER2+ Breast Cancer (PALTAN)
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