Trial Outcomes & Findings for Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer (NCT NCT02827877)

Last Updated: 2025-11-14

Results Overview

The response assessment is performed at the time of definitive surgery. Patients' disease will be staged in the conventional manner according to the AJCC. The primary endpoint is complete pathologic response defined as no evidence of residual invasive cancer in either the breast or regional lymph nodes.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2025-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab. Copper Cu 64-DOTA-Trastuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given IV Positron Emission Tomography: Undergo PET Therapeutic Conventional Surgery: Undergo surgery Trastuzumab: Given IV
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab. Copper Cu 64-DOTA-Trastuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given IV Positron Emission Tomography: Undergo PET Therapeutic Conventional Surgery: Undergo surgery Trastuzumab: Given IV
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) n=18 Participants Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab. Copper Cu 64-DOTA-Trastuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given IV Positron Emission Tomography: Undergo PET Therapeutic Conventional Surgery: Undergo surgery Trastuzumab: Given IV
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Age, Continuous	54.9 years n=10 Participants
Sex: Female, Male Female	18 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=10 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian; Non-Hispanic or Latino	4 Participants n=10 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black; Non-Hispanic or Latino	2 Participants n=10 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian; Hispanic or Latino	8 Participants n=10 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian; Non-Hispanic or Latino	3 Participants n=10 Participants
Race/Ethnicity, Customized Race/Ethnicity · Not Disclosed; Hispanic or Latino	1 Participants n=10 Participants
Region of Enrollment United States	18 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: protocol patients

Outcome measures

Outcome measures
Measure	Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) n=18 Participants Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab. Copper Cu 64-DOTA-Trastuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given IV Positron Emission Tomography: Undergo PET Therapeutic Conventional Surgery: Undergo surgery Trastuzumab: Given IV
Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy). Response	14 Participants
Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy). Non-response	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: protocol patients

First Scan SUV Maximum, measurement by 64Cu-DOTA trastuzumab PET SUV is "Standard Uptake Value". SUV = tumor activity concentration x patient body weight/injected activity decay-corrected to time of scan.

Outcome measures

Outcome measures
Measure	Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) n=18 Participants Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab. Copper Cu 64-DOTA-Trastuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given IV Positron Emission Tomography: Undergo PET Therapeutic Conventional Surgery: Undergo surgery Trastuzumab: Given IV
SUV Measurement by 64Cu-DOTA Trastuzumab PET	6.6 SUV Interval 3.5 to 16.2

Adverse Events

Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET)

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) n=18 participants at risk Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab. Copper Cu 64-DOTA-Trastuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given IV Positron Emission Tomography: Undergo PET Therapeutic Conventional Surgery: Undergo surgery Trastuzumab: Given IV
Eye disorders acute hordeola of the right upper eyelid	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Infections and infestations bacteriemia	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.

Other adverse events

Other adverse events
Measure	Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) n=18 participants at risk Patients receive trastuzumab IV over 15 minutes immediately before receiving copper Cu 64-DOTA-trastuzumab IV on day 0. Patients undergo PET scans at 18-24 and 42-48 hours, on day 1 and day 2. Within 4 days after completion of PET scans, patients receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks and pertuzumab IV over 30-60 minutes. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after 6 cycles of trastuzumab and pertuzumab. Copper Cu 64-DOTA-Trastuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pertuzumab: Given IV Positron Emission Tomography: Undergo PET Therapeutic Conventional Surgery: Undergo surgery Trastuzumab: Given IV
General disorders 10016791-Flu like symptoms	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
General disorders 10033371-Pain	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
General disorders 10050068-Edema limbs	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
General disorders 10051792-Infusion related reaction	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
General disorders 10062466-Localized edema	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Infections and infestations 10046571-Urinary tract infection	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Infections and infestations 10069138-Papulopustular rash	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Injury, poisoning and procedural complications 10006504-Bruising	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Investigations 10001551-Alanine aminotransferase increased	27.8% 5/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Investigations 10001675-Alkaline phosphatase increased	27.8% 5/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Investigations 10003481-Aspartate aminotransferase increased	22.2% 4/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Investigations 10011368-Creatinine increased	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Investigations 10025256-Lymphocyte count decreased	27.8% 5/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Investigations 10029366-Neutrophil count decreased	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Investigations 10035528-Platelet count decreased	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Investigations 10047900-Weight loss	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Investigations 10049182-White blood cell decreased	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders 10002646-Anorexia	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders 10020587-Hypercalcemia	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders 10020639-Hyperglycemia	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders 10020943-Hypoalbuminemia	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders 10020949-Hypocalcemia	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders 10021018-Hypokalemia	22.2% 4/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders 10021028-Hypomagnesemia	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders 10021038-Hyponatremia	27.8% 5/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders 10021059-Hypophosphatemia	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Metabolism and nutrition disorders increased appetite	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders 10003239-Arthralgia	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders 10006002-Bone pain	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders 10028411-Myalgia	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Respiratory, thoracic and mediastinal disorders 10041367-Sore throat	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Respiratory, thoracic and mediastinal disorders itchy throat	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders 10001760-Alopecia	33.3% 6/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders 10037847-Rash acneiform	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders 10037868-Rash maculo-papular	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders 10040865-Skin hyperpigmentation	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders rectal pressure	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders worsening acid reflux	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
General disorders 10008531-Chills	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
General disorders 10016256-Fatigue	72.2% 13/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
General disorders 10016558-Fever	33.3% 6/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Blood and lymphatic system disorders 10002272-Anemia	55.6% 10/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Cardiac disorders 10040741-Sinus bradycardia	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Cardiac disorders 10040752-Sinus tachycardia	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Ear and labyrinth disorders 10043882-Tinnitus	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Eye disorders 10047848-Watering eyes	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Eye disorders acute hordeola of the right upper eyelid	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Eye disorders twitching in L eye	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders 10000081-Abdominal pain	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders 10005265-Bloating	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders 10010774-Constipation	38.9% 7/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders 10012727-Diarrhea	77.8% 14/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders 10028130-Mucositis oral	27.8% 5/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders 10028813-Nausea	77.8% 14/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders 10047700-Vomiting	22.2% 4/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders 10066874-Gastroesophageal reflux disease	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders dry heaving	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Gastrointestinal disorders pain - R side near the waist	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders 10062572-Generalized muscle weakness	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders bilateral leg cramping	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders finger stiffness	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders generalized body pain	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders hip pain	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders intermittent lower back pain	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders intermittent muscle cramps (hands)	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders posterior neck pain	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Musculoskeletal and connective tissue disorders twisted left ankle	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Nervous system disorders 10013573-Dizziness	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Nervous system disorders 10013911-Dysgeusia	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Nervous system disorders 10019211-Headache	22.2% 4/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Nervous system disorders 10034620-Peripheral sensory neuropathy	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Nervous system disorders drowsiness	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Psychiatric disorders 10001497-Agitation	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Psychiatric disorders 10002855-Anxiety	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Psychiatric disorders 10012378-Depression	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Psychiatric disorders 10038743-Restlessness	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Psychiatric disorders insomnia and nightmares	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Psychiatric disorders panic attacks	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Reproductive system and breast disorders 10006298-Breast pain	22.2% 4/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Reproductive system and breast disorders 10046904-Vaginal dryness	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Reproductive system and breast disorders 10046912-Vaginal hemorrhage	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Reproductive system and breast disorders sensation in the R breast after the herceptin infusion	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Respiratory, thoracic and mediastinal disorders 10011224-Cough	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Respiratory, thoracic and mediastinal disorders 10013963-Dyspnea	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Respiratory, thoracic and mediastinal disorders 10015090-Epistaxis	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Respiratory, thoracic and mediastinal disorders 10020201-Hoarseness	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders 10054524-Palmar-plantar erythrodysesthesia syndrome	16.7% 3/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders acne (chin)	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders hair follicle dicomfort	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders mosquito bites	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders pustules on face	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders rash - arms and anterior chest	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Skin and subcutaneous tissue disorders skin changes R forarm	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Vascular disorders 10020407-Hot flashes	11.1% 2/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Vascular disorders 10020772-Hypertension	44.4% 8/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.
Vascular disorders 10021097-Hypotension	5.6% 1/18 • Adverse events occurred over a period of 2 years. Adverse events were collected for all 18 patients.

Additional Information

Dr. Joanne Mortimer

City of Hope Medical Center

Phone: 626-359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place