Trial Outcomes & Findings for Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression (NCT NCT00944047)
NCT ID: NCT00944047
Last Updated: 2018-04-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
22 weeks
Results posted on
2018-04-23
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery
nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks
trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles
cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
\- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.
Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=32 Participants
Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery
nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks
trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles
cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
\- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.
Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 22 weeksOutcome measures
| Measure |
Intervention Arm
n=32 Participants
Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery
nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks
trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles
cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
\- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.
Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.
|
|---|---|
|
Pathologic Complete Response
|
26 percentage of participants
|
Adverse Events
Intervention Arm
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Arm
n=32 participants at risk
Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery
nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks
trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles
cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
\- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.
Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.
|
|---|---|
|
Infections and infestations
Febrile neutropenia
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
General disorders
Pain
|
3.1%
1/32 • Number of events 2 • 18 weeks
|
Other adverse events
| Measure |
Intervention Arm
n=32 participants at risk
Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery
nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks
trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles
cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
\- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.
Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Immune system disorders
Rhinitis
|
9.4%
3/32 • Number of events 3 • 18 weeks
|
|
Ear and labyrinth disorders
Otitis, middle
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Blood and lymphatic system disorders
Blood - Other (Specify)
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Blood and lymphatic system disorders
Hemoglobin
|
15.6%
5/32 • Number of events 5 • 18 weeks
|
|
Blood and lymphatic system disorders
Leukocytes
|
6.2%
2/32 • Number of events 5 • 18 weeks
|
|
Blood and lymphatic system disorders
Neutrophils
|
21.9%
7/32 • Number of events 10 • 18 weeks
|
|
Cardiac disorders
Palpitations
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Cardiac disorders
Vasovagal episode
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Cardiac disorders
Hypotension
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
General disorders
Fatigue
|
84.4%
27/32 • Number of events 48 • 18 weeks
|
|
General disorders
Fever
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Psychiatric disorders
Insomnia
|
50.0%
16/32 • Number of events 20 • 18 weeks
|
|
General disorders
Rigors/chills
|
12.5%
4/32 • Number of events 4 • 18 weeks
|
|
Investigations
Weight gain
|
12.5%
4/32 • Number of events 8 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.6%
5/32 • Number of events 7 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.4%
3/32 • Number of events 3 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Flushing
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
46.9%
15/32 • Number of events 17 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
4/32 • Number of events 4 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
16/32 • Number of events 28 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
3.1%
1/32 • Number of events 2 • 18 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Endocrine disorders
Hot flashes
|
15.6%
5/32 • Number of events 7 • 18 weeks
|
|
Gastrointestinal disorders
Abdominal distention
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Gastrointestinal disorders
Anorexia
|
21.9%
7/32 • Number of events 11 • 18 weeks
|
|
Gastrointestinal disorders
Colitis
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Gastrointestinal disorders
Constipation
|
50.0%
16/32 • Number of events 20 • 18 weeks
|
|
Gastrointestinal disorders
Dehydration
|
12.5%
4/32 • Number of events 7 • 18 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
46.9%
15/32 • Number of events 22 • 18 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
9.4%
3/32 • Number of events 3 • 18 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
18.8%
6/32 • Number of events 6 • 18 weeks
|
|
Gastrointestinal disorders
Esophageal mucositis
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Gastrointestinal disorders
Esophagitis
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Gastrointestinal disorders
Heartburn
|
9.4%
3/32 • Number of events 3 • 18 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
21.9%
7/32 • Number of events 9 • 18 weeks
|
|
Gastrointestinal disorders
Nausea
|
78.1%
25/32 • Number of events 36 • 18 weeks
|
|
Gastrointestinal disorders
Pharyngeal examination abnormal
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Gastrointestinal disorders
Taste alteration
|
28.1%
9/32 • Number of events 11 • 18 weeks
|
|
Gastrointestinal disorders
Tooth disorder
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
8/32 • Number of events 11 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
4/32 • Number of events 4 • 18 weeks
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
3.1%
1/32 • Number of events 2 • 18 weeks
|
|
Infections and infestations
Eye infection
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Infections and infestations
Febrile neutropenia
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Infections and infestations
Infection - Other (Specify)
|
12.5%
4/32 • Number of events 7 • 18 weeks
|
|
Infections and infestations
Infection, normal ANC, Lip/perioral
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Infections and infestations
Infection, Urinary tract NOS
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Infections and infestations
Nail infection
|
6.2%
2/32 • Number of events 3 • 18 weeks
|
|
Infections and infestations
Otitis media
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Infections and infestations
Sinusitis
|
9.4%
3/32 • Number of events 5 • 18 weeks
|
|
Infections and infestations
Upper respiratory infection
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Infections and infestations
Urinary tract infection
|
12.5%
4/32 • Number of events 5 • 18 weeks
|
|
Infections and infestations
Vaginal infection
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Dermal change
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
General disorders
Edema limbs
|
18.8%
6/32 • Number of events 8 • 18 weeks
|
|
General disorders
Edema: head and neck
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Metabolism and nutrition disorders
Creatinine increased
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
34.4%
11/32 • Number of events 12 • 18 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
15.6%
5/32 • Number of events 7 • 18 weeks
|
|
Psychiatric disorders
Agitation
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Psychiatric disorders
Anxiety
|
18.8%
6/32 • Number of events 6 • 18 weeks
|
|
Psychiatric disorders
Depression
|
9.4%
3/32 • Number of events 3 • 18 weeks
|
|
Nervous system disorders
Dizziness
|
21.9%
7/32 • Number of events 10 • 18 weeks
|
|
Psychiatric disorders
Euphoria
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Nervous system disorders
Memory impairment
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
68.8%
22/32 • Number of events 27 • 18 weeks
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Nervous system disorders
Trigeminal nerve disorder
|
3.1%
1/32 • Number of events 2 • 18 weeks
|
|
Eye disorders
Blurred vision
|
3.1%
1/32 • Number of events 2 • 18 weeks
|
|
Eye disorders
Dry eye syndrome
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Eye disorders
Watering eyes
|
15.6%
5/32 • Number of events 6 • 18 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
6/32 • Number of events 7 • 18 weeks
|
|
Gastrointestinal disorders
Anal pain
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • Number of events 3 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.4%
3/32 • Number of events 3 • 18 weeks
|
|
Cardiac disorders
Chest pain
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Cardiac disorders
Chest wall pain
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Eye disorders
Eye pain
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Nervous system disorders
Headache
|
31.2%
10/32 • Number of events 11 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
25.0%
8/32 • Number of events 11 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Gastrointestinal disorders
Oral pain
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain
|
21.9%
7/32 • Number of events 8 • 18 weeks
|
|
Gastrointestinal disorders
Pharyngolaryngeal pain
|
18.8%
6/32 • Number of events 7 • 18 weeks
|
|
Gastrointestinal disorders
Rectal pain
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Renal and urinary disorders
Urethral pain
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Reproductive system and breast disorders
Vaginal pain
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
12/32 • Number of events 13 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Renal and urinary disorders
Cystitis
|
6.2%
2/32 • Number of events 2 • 18 weeks
|
|
Renal and urinary disorders
Urinary frequency
|
12.5%
4/32 • Number of events 5 • 18 weeks
|
|
Renal and urinary disorders
Urinary retention
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
|
General disorders
Flu-like syndrome
|
3.1%
1/32 • Number of events 1 • 18 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place