PALTAN: Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
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 |
---|---|---|
|
Phase 2 |
Study Design
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:
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:
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:
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:
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
- 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
- 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.
- 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
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.- 201610019
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
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%
|
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%
|
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
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 |
bisiademuyiwa@wustl.edu |
- 201610019