Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/19/2018
Start Date:June 30, 2017
End Date:November 30, 2024
Contact:Foluso O Ademuyiwa, M.D., MPH
Email:bisiademuyiwa@wustl.edu
Phone:(314) 454-8313

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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)

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.


Inclusion Criteria:

- 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.

- 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).

Exclusion Criteria:

- 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.
We found this trial at
5
sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Ellis Levine, M.D.
Phone: 716-845-2900
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Bloomington, Indiana 46202
Principal Investigator: Kathy D Miller, M.D.
Phone: 317-948-3885
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2670 Chancellor Drive
Edgewood, Kentucky 41017
Phone: 859-344-1600
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Laredo, Texas 78041
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Foluso O Ademuyiwa, M.D., MPH
Phone: 314-454-8313
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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