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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT02907918
Collaborator
Pfizer (Industry), Rising Tide Foundation (Other)
26
3
1
38.8
8.7
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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)
Actual Study Start Date :
Jun 30, 2017
Actual Primary Completion Date :
Aug 24, 2020
Actual Study Completion Date :
Sep 23, 2020

Arms and Interventions

Arm Intervention/Treatment
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

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Pathologic Complete Response (pCR) [Completion of 4 cycles of treatment (approximately 16 weeks)]

      A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes.

    Secondary Outcome Measures

    1. Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events [30 days after completion of neoadjuvant therapy (approximately 21 weeks)]

      -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

    2. Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE [Baseline, cycle 2 day 1 (approximately 29 days), and end of cycle 4 (approximately 16 weeks)]

      Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4) PRO-CTCAE responses are scored from 0 to 4, and there are no standardized scoring rules yet established for how to combine attributes into a single score or how best to analyze PRO-CTCAE data longitudinally. PRO-CTCAE scores for each attribute (frequency, severity and/or interference) will be presented descriptively

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Phoenix Arizona United States 85054
    2 Washington University School of Medicine Saint Louis Missouri United States 63110
    3 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

    • Washington University School of Medicine
    • Pfizer
    • Rising Tide Foundation

    Investigators

    • Principal Investigator: Foluso O Ademuyiwa, M.D, MPH, Washington University School of Medicine

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02907918
    Other Study ID Numbers:
    • 201610019
    First Posted:
    Sep 20, 2016
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Palbociclib + Letrozole + Trastuzumab +/- Goserelin
    Arm/Group Description 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
    Period Title: Overall Study
    STARTED 26
    COMPLETED 26
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Palbociclib + Letrozole + Trastuzumab +/- Goserelin
    Arm/Group Description 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
    Overall Participants 26
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    59
    Sex: Female, Male (Count of Participants)
    Female
    26
    100%
    Male
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    26
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    2
    7.7%
    White
    24
    92.3%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    26
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Pathologic Complete Response (pCR)
    Description A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes.
    Time Frame Completion of 4 cycles of treatment (approximately 16 weeks)

    Outcome Measure Data

    Analysis Population Description
    One participant is not evaluable for this outcome measure because the participant experienced progressive disease after completion of treatment but prior to surgery.
    Arm/Group Title Palbociclib + Letrozole + Trastuzumab +/- Goserelin
    Arm/Group Description 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
    Measure Participants 25
    Count of Participants [Participants]
    2
    7.7%
    2. Secondary Outcome
    Title Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events
    Description -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
    Time Frame 30 days after completion of neoadjuvant therapy (approximately 21 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Palbociclib + Letrozole + Trastuzumab +/- Goserelin
    Arm/Group Description 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
    Measure Participants 26
    Neutrophil count decreased
    13
    50%
    Lymphocyte count decreased
    1
    3.8%
    Hypertension
    8
    30.8%
    White blood cell decreased
    2
    7.7%
    Colitis
    1
    3.8%
    Hypokalemia
    1
    3.8%
    Pulmonary edema
    1
    3.8%
    Ventricular tachycardia
    1
    3.8%
    Alanine aminotransferase increased
    1
    3.8%
    Aspartate aminotransferase increased
    1
    3.8%
    Colonic obstruction
    1
    3.8%
    3. Secondary Outcome
    Title Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE
    Description Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4) PRO-CTCAE responses are scored from 0 to 4, and there are no standardized scoring rules yet established for how to combine attributes into a single score or how best to analyze PRO-CTCAE data longitudinally. PRO-CTCAE scores for each attribute (frequency, severity and/or interference) will be presented descriptively
    Time Frame Baseline, cycle 2 day 1 (approximately 29 days), and end of cycle 4 (approximately 16 weeks)

    Outcome Measure Data

    Analysis Population Description
    3 participants at the end of cycle 4 did not complete the questionnaire.
    Arm/Group Title Baseline: Palbociclib + Letrozole + Trastuzumab +/- Goserelin Cycle 2 Day 1: Palbociclib + Letrozole + Trastuzumab +/- Goserelin End of Cycle 4: Palbociclib + Letrozole + Trastuzumab +/- Goserelin
    Arm/Group Description 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 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 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
    Measure Participants 26 26 23
    In the last 7 days, what was the severity of your decreased appetite at its worst?
    1.3461538
    (0.8918434)
    1.3461538
    (0.6894814)
    1.3043478
    (0.8756703)
    In the last 7 days, how much did decreased appetite interfere with your usual or daily activities?
    1.0769231
    (0.8448942)
    0.9615385
    (0.3441824)
    1.0434783
    (0.3665888)
    In the last 7 days, how often did you have nausea?
    1.2307692
    (0.5870395)
    1.5000000
    (0.9899495)
    1.2608696
    (0.5408236)
    In the last 7 days, what was the severity of your nausea at its worst?
    1.1923077
    (0.800961)
    1.4230769
    (0.8566482)
    1.2173913
    (0.6712622)
    In the last 7 days, what was the severity of your shortness of breath (SOB) at its worst?
    1.1923077
    (0.5670436)
    1.1153846
    (0.515901)
    1.4347826
    (0.8957519)
    In the last 7 days, how much did your SOB interfere with your usual or daily activities?
    0.9615385
    (0.4454902)
    1.0384615
    (0.4454902)
    1.173913
    (0.6503268)
    In the last 7 days, what was the severity of your cough at its worst?
    1.1923077
    (0.4019185)
    1.2307692
    (0.5870395)
    1.5217391
    (1.0816471)
    In the last 7 days, how much did your cough interfere with your usual and daily activities?
    1.0000000
    (0.2828427)
    1.0384615
    (0.5276946)
    1.3043478
    (0.9739695)
    In the last 7 days, how often did you have arm or leg swelling?
    1.0000000
    (0.0000000)
    1.0384615
    (0.3441824)
    1.2608696
    (0.9153832)
    In the last 7 days, what was the severity of your arm or leg swelling at its worst?
    0.8846154
    (0.3258126)
    1.0384615
    (0.5276946)
    1.1304348
    (0.4576966)
    In the last 7 days, how much did arm or leg swelling interfere with your usual or daily activities?
    0.9230769
    (0.2717465)
    0.8846154
    (0.3258126)
    1.0434783
    (0.474654)
    In the last 7 days, how often did you feel a pounding or racing heartbeat (palpitations)?
    1.1538462
    (0.4640955)
    1.1923077
    (0.5670436)
    1.173913
    (0.4910262)
    In the last 7 days, what was the severity of your pounding or racing heartbeat at its worst?
    1.0384615
    (0.4454902)
    1.1923077
    (0.6939297)
    1.1304348
    (0.5480833)
    In the last 7 days, did you have any rash?
    1.8461538
    (0.3679465)
    1.6153846
    (0.5710988)
    1.826087
    (0.3875534)
    In the last 7 days, what was the severity of your dry skin at its worst?
    1.3076923
    (0.5491252)
    1.6923077
    (0.8375789)
    1.5652174
    (0.7277666)
    In the last 7 days, did you have any hair loss?
    1.0769231
    (0.2717465)
    1.1153846
    (0.4314555)
    1.6086957
    (0.8913284)
    In the last 7 days, what was the severity of your problems with concentration at their worst?
    1.1923077
    (0.4914656)
    1.5000000
    (0.8602325)
    1.4782609
    (0.7902569)
    In the past 7 days, how much did problems with concentration interfere with usual/daily activities?
    1.1538462
    (0.543493)
    1.3076923
    (0.6793662)
    1.3478261
    (0.9820524)

    Adverse Events

    Time Frame Adverse events were followed from start of treatment through 30 days after last dose of palbociclib.
    Adverse Event Reporting Description
    Arm/Group Title Palbociclib + Letrozole + Trastuzumab +/- Goserelin
    Arm/Group Description 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
    All Cause Mortality
    Palbociclib + Letrozole + Trastuzumab +/- Goserelin
    Affected / at Risk (%) # Events
    Total 0/26 (0%)
    Serious Adverse Events
    Palbociclib + Letrozole + Trastuzumab +/- Goserelin
    Affected / at Risk (%) # Events
    Total 2/26 (7.7%)
    Gastrointestinal disorders
    Colonic obstruction 1/26 (3.8%)
    Injury, poisoning and procedural complications
    Fracture 1/26 (3.8%)
    Respiratory, thoracic and mediastinal disorders
    Pulmonary edema 1/26 (3.8%)
    Vascular disorders
    Hypertension 1/26 (3.8%)
    Other (Not Including Serious) Adverse Events
    Palbociclib + Letrozole + Trastuzumab +/- Goserelin
    Affected / at Risk (%) # Events
    Total 26/26 (100%)
    Blood and lymphatic system disorders
    Anemia 20/26 (76.9%)
    Intravenous antibiotics for positive blood cultures 1/26 (3.8%)
    Lymph node pain 1/26 (3.8%)
    Cardiac disorders
    Palpitations 2/26 (7.7%)
    Ventricular tachycardia 1/26 (3.8%)
    Eye disorders
    Blurred vision 3/26 (11.5%)
    Depth perception change 1/26 (3.8%)
    Dry eye 3/26 (11.5%)
    Stye - left eye 1/26 (3.8%)
    Watering eyes 1/26 (3.8%)
    Gastrointestinal disorders
    Colitis 1/26 (3.8%)
    Constipation 3/26 (11.5%)
    Diarrhea 7/26 (26.9%)
    Dry mouth 1/26 (3.8%)
    Dyspepsia 3/26 (11.5%)
    Hemorrhoids 1/26 (3.8%)
    Mucositis oral 5/26 (19.2%)
    Nausea 8/26 (30.8%)
    Oral pain 1/26 (3.8%)
    Rectal hemorrhage 1/26 (3.8%)
    Stomach ache 1/26 (3.8%)
    Vomiting 3/26 (11.5%)
    General disorders
    Chills 3/26 (11.5%)
    Edema limbs 1/26 (3.8%)
    Fatigue 18/26 (69.2%)
    Fever 1/26 (3.8%)
    Hypertension 16/26 (61.5%)
    Left armpit pain 1/26 (3.8%)
    Pain 2/26 (7.7%)
    Right hip pain 1/26 (3.8%)
    Right underarm edema 1/26 (3.8%)
    Immune system disorders
    Allergic reaction 1/26 (3.8%)
    Seasonal allergies 1/26 (3.8%)
    Infections and infestations
    Bronchial infection 1/26 (3.8%)
    Cold sores 1/26 (3.8%)
    Papulopustular rash 1/26 (3.8%)
    Prophylactic herpes 1/26 (3.8%)
    Redness of nail bed - right 1/26 (3.8%)
    Sinusitis 1/26 (3.8%)
    Upper respiratory infection 1/26 (3.8%)
    Urinary tract infection 1/26 (3.8%)
    Wound infection 1/26 (3.8%)
    Injury, poisoning and procedural complications
    Breast pain - surgery 1/26 (3.8%)
    Pain related to surgery 1/26 (3.8%)
    Investigations
    Alanine aminotransferase increased 7/26 (26.9%)
    Aspartate aminotransferase increased 6/26 (23.1%)
    Creatinine increased 2/26 (7.7%)
    Ejection fraction decreased 1/26 (3.8%)
    Electrocardiogram QT corrected 1/26 (3.8%)
    Lymphocyte count decreased 9/26 (34.6%)
    Neutrophil count decreased 23/26 (88.5%)
    Platelet count decreased 15/26 (57.7%)
    White blood cell decreased 26/26 (100%)
    Metabolism and nutrition disorders
    Anorexia 1/26 (3.8%)
    Hypercalcemia 3/26 (11.5%)
    Hypernatremia 1/26 (3.8%)
    Hypoalbuminemia 1/26 (3.8%)
    Hypocalcemia 2/26 (7.7%)
    Hypokalemia 2/26 (7.7%)
    Hyponatremia 3/26 (11.5%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/26 (11.5%)
    Arthralgia - knees 1/26 (3.8%)
    Arthritis 1/26 (3.8%)
    Back pain 1/26 (3.8%)
    Bone pain 1/26 (3.8%)
    Chest wall pain 1/26 (3.8%)
    Muscle weakness lower limb 1/26 (3.8%)
    Nervous system disorders
    Concentration impairment 2/26 (7.7%)
    Dizziness 4/26 (15.4%)
    Dysgeusia 4/26 (15.4%)
    Headache 11/26 (42.3%)
    Migraine 1/26 (3.8%)
    Paresthesia 1/26 (3.8%)
    Peripheral motor neuropathy 1/26 (3.8%)
    Peripheral sensory neuropathy 2/26 (7.7%)
    Peripheral sensory neuropathy - fingers 1/26 (3.8%)
    Psychiatric disorders
    Anxiety 1/26 (3.8%)
    Insomnia 2/26 (7.7%)
    Reproductive system and breast disorders
    Bilateral breast pain 1/26 (3.8%)
    Breast pain 1/26 (3.8%)
    Vaginal pruritus 1/26 (3.8%)
    Respiratory, thoracic and mediastinal disorders
    Cold/sore throat 1/26 (3.8%)
    Cough 6/26 (23.1%)
    Dry nose 1/26 (3.8%)
    Dyspnea 5/26 (19.2%)
    Epistaxis 9/26 (34.6%)
    Hoarseness 1/26 (3.8%)
    Nasal congestion 2/26 (7.7%)
    Postnasal drip 3/26 (11.5%)
    Pulmonary edema 1/26 (3.8%)
    Runny nose 1/26 (3.8%)
    Sore throat 2/26 (7.7%)
    Wheezing 1/26 (3.8%)
    Skin and subcutaneous tissue disorders
    Acne on nose 1/26 (3.8%)
    Alopecia 3/26 (11.5%)
    Dry skin 3/26 (11.5%)
    Erythema multiforme 1/26 (3.8%)
    Facial rash 1/26 (3.8%)
    Hyperhidrosis 1/26 (3.8%)
    Itchy rash bilateral arms 1/26 (3.8%)
    Mild rash face/chin 1/26 (3.8%)
    Papular urticaria 1/26 (3.8%)
    Peeling fingers 1/26 (3.8%)
    Pruritis 2/26 (7.7%)
    Rash 2/26 (7.7%)
    Rash acneiform 1/26 (3.8%)
    Rash maculopapular 3/26 (11.5%)
    Rash near port site 1/26 (3.8%)
    Sensitive skin 1/26 (3.8%)
    Skin pain 1/26 (3.8%)
    Stye 1/26 (3.8%)
    Vascular disorders
    Hot flashes 5/26 (19.2%)
    Hypertension 15/26 (57.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Foluso O. Ademuyiwa, M.D., MPH
    Organization Washington University School of Medicine
    Phone 314-454-8313
    Email bisiademuyiwa@wustl.edu
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02907918
    Other Study ID Numbers:
    • 201610019
    First Posted:
    Sep 20, 2016
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021