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

NCT02907918

Last updated date
Study Location
Mayo Clinic
Phoenix, Arizona, 85054, United States
Contact
(314) 454-8313

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Cancer of Breast, Breast Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Breast Cancer, Cancer of Breast, Breast CarcinomaNeoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
NCT02907918
  1. Phoenix, Arizona
  2. Saint Louis, Missouri
  3. Buffalo, New York
  4. Laredo, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Cancer of Breast
  • Breast Carcinoma
Intervention  ICMJE
  • Drug: Palbociclib
    Palbociclib is an oral drug given at a dose of 125 mg daily on Days 1-21 of each 28-day cycle for a total of 4 cycles.
    Other Name: Ibrance
  • Drug: Letrozole
    Letrozole is an oral drug given at a dose of 2.5 mg orally once a day. It will be taken continuously (Days 1-28 of each cycle) until the day of definitive surgery.
    Other Name: Femara®
  • Biological: Trastuzumab
    • Or FDA approved biosimilar
    • Trastuzumab will be administered on a weekly basis for 16 weeks (on Days 1, 8, 15, and 22 of each 28-day cycle for a total of 4 cycles). The first dose of trastuzumab on Cycle 1 Day 1 will be a loading dose of 4 mg/kg IVPB over 90 minutes. Subsequent doses of trastuzumab will be 2 mg/kg IVPB over 30 minutes. Weekly trastuzumab will continue after the completion of Cycle 4 of palbociclib until surgery.
    Other Name: Herceptin®
  • Drug: Goserelin
    Goserelin is given subcutaneously at a dose of 3.6 mg on Day 1 of each cycle. Goserelin will be continued (once every 28-days) after the completion of Cycle 4 of palbociclib if required.
    Other Name: Zoladex
  • Procedure: Breast surgery
    Standard of care
  • Procedure: Research tumor biopsy
    Baseline, cycle 1 day 15, and surgery
  • Procedure: Research bone marrow (OPTIONAL)
    Baseline and surgery
  • Procedure: Research blood sample
    Baseline, cycle 1 day 15, surgery, and yearly post-surgery for 5 years
  • Genetic: Research blood for germline DNA
    Baseline
  • Procedure: Blood for detection of circulating tumor cells
    Baseline
Study Arms  ICMJE Experimental: Palbociclib + letrozole + trastuzumab +/- goserelin
  • Neoadjuvant palbociclib + letrozole (plus goserelin if premenopausal) + trastuzumab for a total of 16 weeks, consisting of (4) 28-day cycles
  • Definitive surgery will be performed preferably within 6 weeks after the end of Cycle 4. Letrozole and trastuzumab will continue until the day of surgery. Letrozole will continue to be taken daily and trastuzumab will be given every 3 weeks per standard of care guidelines. Adjuvant therapy following definitive surgery will be at the discretion of the treating physician
Interventions:
  • Drug: Palbociclib
  • Drug: Letrozole
  • Biological: Trastuzumab
  • Drug: Goserelin
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2016)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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).

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Foluso O Ademuyiwa, M.D., MPH(314) 454-8313[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02907918
Other Study ID Numbers  ICMJE 201610019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • Pfizer
  • Rising Tide Foundation
Investigators  ICMJE
Principal Investigator:Foluso O Ademuyiwa, M.D, MPHWashington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP