Trial Outcomes & Findings for Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis (NCT NCT02774681)

Last Updated: 2020-04-14

Results Overview

Assess the Radiographic Response Rate (RRR) in the CNS by modified Response Assessment in Neuro-Oncology Criteria Brain Metastasis (modifiedRANO-BM). Maximum response prior to disease progression will be used. In General: Complete Response : Disappearance of all lesions Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2020-04-14

Participant Flow

The study opened to accrual May 25, 2016 with the first patient being treated on study August 31,2016. the total accrual goal of 25 patients. The study closed to further accrual January 28, 2019 with 12 patients enrolled on the study

Participant milestones

Participant milestones
Measure	Treatment (Palbociclib) Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Treatment on Study STARTED	12
Treatment on Study Reached 1st Response/2 Cycles	10
Treatment on Study Went on to Start Cycle 3	5
Treatment on Study COMPLETED	5
Treatment on Study NOT COMPLETED	7
Follow-Up for 3 Years STARTED	12
Follow-Up for 3 Years COMPLETED	0
Follow-Up for 3 Years NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Palbociclib) Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Treatment on Study Progressive Disease	7
Follow-Up for 3 Years Death	11
Follow-Up for 3 Years Withdrawal by Subject	1

Baseline Characteristics

Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Palbociclib) n=12 Participants Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Below table shows best response (Clinical and radiological) of all patients treated on study. Patients that did not complete 2 cycles of treatment required for evaluability for response rate objective are shown. No RRR was not calculated as the study did not met statistical analysis criteria due to study closing before total accrual was met.

Outcome measures

Outcome measures
Measure	Treatment (Palbociclib) n=12 Participants Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Radiographic Response Rate (RRR) in the CNS in Patients With HER2-positive Breast Cancer Who Have Brain Metastasis Treated With Palbociclib Stable Disease CNS	6 Participants
Radiographic Response Rate (RRR) in the CNS in Patients With HER2-positive Breast Cancer Who Have Brain Metastasis Treated With Palbociclib Progressive Disease CNS	6 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Data not collected for analysis

Determine the safety and tolerability of palbociclib in patients with HER2-positive breast cancer by evaluating number, frequency, and severity of adverse events using Common Terminology Criteria for Adverse Events version 4.03. The number of patients that experienced SAEs that were determined to be at least possibly related to study drug are reported below.

Outcome measures

Outcome measures
Measure	Treatment (Palbociclib) n=12 Participants Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Incidence of Adverse Events	1 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: one patient withdrew consent to be followed for survival

Evaluate OS in patients with HER2-positive breast cancer who have brain metastasis treated with palbociclib. OS is defined as the time from treatment initiation until death due to any cause. Number of patients remaining alive as of the last follow up date, is reported below.

Outcome measures

Outcome measures
Measure	Treatment (Palbociclib) n=11 Participants Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Overall Survival (OS)	0 participants alive

SECONDARY outcome

Timeframe: Up to 3 years

Population: Not sufficient patients enrolled for statistical analysis due to study closing to accrual before the accrual goal was met. Number of patients shown below is the number of patients that discontinued treatment due to progression.

Determine the PFS in patients with HER2-positive breast cancer who have brain metastasis treated with palbociclib where PFS is defined as the time from treatment initiation to documented disease progression or death for any reason. Below shows the number of patient who discontinued treatment due to progression of disease.

Outcome measures

Outcome measures
Measure	Treatment (Palbociclib) n=12 Participants Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Progression Free Survival (PFS)	11 patients

SECONDARY outcome

Timeframe: Up to 3 years

Population: All patient data is shown. Patients that did not complete 2 cycles of treatment required for response are also included as there was no analysis of the data.

Evaluate systemic ORR defined as partial response or complete response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 where: Complete Response = complete disappearance of all lesions Partial Response = At least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Treatment (Palbociclib) n=12 Participants Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Overall Response Rate (ORR)	0 participants

SECONDARY outcome

Timeframe: Up to 3 years

Treatment (Palbociclib)

Serious events: 6 serious events

Other events: 12 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Palbociclib) n=12 participants at risk Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Psychiatric disorders Confusion	8.3% 1/12 • Number of events 1 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Hydrocephalus	8.3% 1/12 • Number of events 1 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Vascular disorders Thromboembolic Event	16.7% 2/12 • Number of events 2 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Seizure	16.7% 2/12 • Number of events 2 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)

Other adverse events

Other adverse events
Measure	Treatment (Palbociclib) n=12 participants at risk Patients receive palbociclib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with HER2 positive breast cancer may also receive trastuzumab IV over 30-90 minutes every 3 weeks. Cognitive Assessment: Ancillary studies Palbociclib: Given PO Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Blood and lymphatic system disorders Anemia	66.7% 8/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Endocrine disorders Hypothyroidism	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Eye disorders Blurred Vision	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Eye disorders Watery Eyes	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Gastrointestinal disorders Abdominal Pain	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Gastrointestinal disorders Diarrhea	16.7% 2/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Gastrointestinal disorders Nausea	25.0% 3/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Gastrointestinal disorders Stomach Pain	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Gastrointestinal disorders Vomiting	16.7% 2/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
General disorders Fatigue	41.7% 5/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
General disorders Flu Like Symptoms	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
General disorders Gait Disturbance	16.7% 2/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
General disorders Malaise	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
General disorders Pain	16.7% 2/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Infections and infestations Tooth Infection	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Investigations Alanine aminotransferase increased	16.7% 2/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Investigations Alkaline phosphatase increased	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Investigations Aspartate aminotransferase increased	33.3% 4/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Investigations Creatinine Increased	16.7% 2/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Investigations Lymphocyte Count Decreased	58.3% 7/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Investigations Neutrophil Count Decreased	66.7% 8/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Investigations Platelet count Decreased	50.0% 6/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Investigations White Blood Cell Decreased	83.3% 10/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Metabolism and nutrition disorders Hyperglycemia	50.0% 6/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 3/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Metabolism and nutrition disorders Hyponatremia	16.7% 2/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Musculoskeletal and connective tissue disorders Chest Wall Pain	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Musculoskeletal and connective tissue disorders Pain in Extremity	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Cognitive Disturbance	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Dysphasia	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Headache	16.7% 2/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Memory Impairment	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Paresthesia	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Peripheral Motor Neuropathy	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Peripheral Sensory Neuropathy	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Seizure	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Nervous system disorders Somnolence	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Psychiatric disorders Anxiety	16.7% 2/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Psychiatric disorders Confusion	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Psychiatric disorders Depression	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Psychiatric disorders Hallucinations	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Renal and urinary disorders Chronic Kidney Disease	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Reproductive system and breast disorders Pelvic Pain	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Respiratory, thoracic and mediastinal disorders Hoarseness	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Respiratory, thoracic and mediastinal disorders Laryngeal Inflammation	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Respiratory, thoracic and mediastinal disorders Sore Throat	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Skin and subcutaneous tissue disorders Rash Maculo-Papular	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Vascular disorders Hypertension	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Vascular disorders Lymphedema	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Investigations Low GFR	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Metabolism and nutrition disorders Hypertriglyceridemia	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)
Skin and subcutaneous tissue disorders Stomatitis	8.3% 1/12 • Adverse Events were collected over a 2 and half year period for the study. For each patient they were collected from treatment initiation until 30 days post the last treatment with range of cycles completed by patients being less than 1 Cycle to 5 Cycles (1 Cycle = 28 Days)

Additional Information

Massimo Cristofanilli, MD

Northwestern University

Phone: 312-503-5488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place