Trial Outcomes & Findings for Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer (NCT NCT00464646)
NCT ID: NCT00464646
Last Updated: 2021-10-25
Results Overview
The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Assessed at time of surgery on average at 8 months
Results posted on
2021-10-25
Participant Flow
Participant milestones
| Measure |
Cohort A
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
29
|
|
Overall Study
COMPLETED
|
76
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort A
n=76 Participants
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
n=29 Participants
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Age, Customized
18 to less than 50 years
|
39 participants
n=5 Participants
|
10 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Age, Customized
>=50 years and <=59 years
|
27 participants
n=5 Participants
|
8 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Age, Customized
> 59 years
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
65 participants
n=5 Participants
|
26 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
70 participants
n=5 Participants
|
29 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at time of surgery on average at 8 monthsPopulation: 73 of the 76 patients in Cohort A were analyzed: 2 patients did not have surgery and 1 patient did not have the nodal status determined.
The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.
Outcome measures
| Measure |
Cohort A
n=73 Participants
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)
|
34 participants
Interval 34.8 to 58.63
|
—
|
PRIMARY outcome
Timeframe: Cohort A: Baseline, post-treatment with EC, 2-4 weeks after surgery, and 9, 12, 15, and 18 months from study entry. Cohort B: Baseline, post-treatment with EC, 2-3 weeks after the last dose of docetaxel, and 6, 9, 12, 15, and 18 months from study entry.The number of cardiac events defined as NYHA Class III/IV CHF and cardiac death.To determine the rate of cardiac events (NYHA Class III/IV CHF and cardiac death) of a regimen of EC followed by THA when administered to: Cohort A as neoadjuvant therapy for HER-2 positive locally advanced (clinical stage IIIA, IIIB or IIIC breast cancer or Cohort B as adjuvant therapy for resected HER2-positive pN2 or pN3 (pathologic stage III) breast cancer. The number of participants with one or more cardiac events are being reported.
Outcome measures
| Measure |
Cohort A
n=70 Participants
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
n=29 Participants
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Number of Participants With Cardiac Events
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at the time of surgeryPopulation: Endpoint was for Cohort A only.70
The determination of pCR will be performed by the local pathologist following examination of tissue (breast and nodes) removed at the time of surgery.
Outcome measures
| Measure |
Cohort A
n=70 Participants
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Number of Participants With no Histologic Evidence of Invasive Tumor Cells in the Surgical Breast Specimen.
|
36 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Determined at baseline, 2-3 weeks after the last EC dose, 2-4 weeks after last Docetaxel dose-before surgery.Population: This outcome only applicable to Cohort A.
cCR following the last dose of docetaxel (Cohort A). cCR is detemined by tumor measurement by physical exam at baseline: target lesions greater than or equal to 2.0 cm; non-target lesions greater than or equal to 2.0 cm. cCR assessment at other timepoints: resolution of all target and non-target lesions identified at baseline, and no new lesions or other signs of disease progression.
Outcome measures
| Measure |
Cohort A
n=70 Participants
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Clinical Complete Response (cCR)
|
61.43 percentage of patients
Interval 49.03 to 72.83
|
—
|
SECONDARY outcome
Timeframe: Before each cycle of pre-op Rx; 2-4 wks after the last docetaxel dose; 2-4 wks post surgery (Cohort A); every 6 wks during post-op Rx (Cohort A); every 6 wks during targeted therapy alone (Cohort B); RT complications assessed at 12 mos from study entryPopulation: Data shows total number of patients with 1 AE, for further information see Reported Adverse Events Section.
Outcome measures
| Measure |
Cohort A
n=76 Participants
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
n=29 Participants
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)
|
55 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study therapy until the date of recurrence or for a maximum of five (5) years from study entryTo determine the five-year RFS.
Outcome measures
| Measure |
Cohort A
n=70 Participants
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
n=29 Participants
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Recurrence-free Survival
|
75.97 percentage of patients
Interval 63.5 to 85.67
|
89.66 percentage of patients
Interval 71.2 to 96.54
|
SECONDARY outcome
Timeframe: From the first dose of study therapy until the date of death or for a maximum of five (5) years from study entryDeath from any cause during the 5 years from study entry.
Outcome measures
| Measure |
Cohort A
n=76 Participants
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
n=29 Participants
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Overall Survival
|
12 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2-4 weeks after surgery and at 9 and 12 months from study entryThe percentage of patients with surgical complications (from mastectomy, lumpectomy, and axillary staging procedures).
Outcome measures
| Measure |
Cohort A
n=74 Participants
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Percentage of Participants With Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)
|
37 Participants
|
—
|
Adverse Events
Cohort A
Serious events: 16 serious events
Other events: 76 other events
Deaths: 0 deaths
Cohort B
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A
n=76 participants at risk
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
n=29 participants at risk
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
General disorders
Pain- head/headache
|
3.9%
3/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
General disorders
Pain- back
|
2.6%
2/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
General disorders
Pain- extremity-limb
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
General disorders
Pain- joint
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
General disorders
Pain- NOS
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
General disorders
Pain- chest/thorax
|
0.00%
0/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Infections and infestations
Infection with normal ANC - skin (cellulites)
|
2.6%
2/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Infections and infestations
Infection with Normal ANC - bladder (urinary)
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Gastrointestinal disorders
Dehydration
|
1.3%
1/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Metabolism and nutrition disorders
Creatinine
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Cardiac disorders
Left ventricular systolic function
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Cardiac disorders
Hypertension
|
0.00%
0/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Gastrointestinal disorders
Hemorrhage, GI - stomach
|
0.00%
0/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Nervous system disorders
Neuropathy
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
General disorders
Syncope
|
2.6%
2/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Psychiatric disorders
Mood alteration - depression
|
2.6%
2/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
General disorders
Pain - neck
|
2.6%
2/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Investigations
Hypertriglyceridemia
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Infections and infestations
Infection documented clinically or micro with grade 4 neutrophils - blood
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Infections and infestations
Infection with unknown ANC - wound
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Infections and infestations
Infection other - colon
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Infections and infestations
Infection other - skin (cellulitis)
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
General disorders
Myositis
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Nervous system disorders
Neurology - other - loss of consciousness
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Gastrointestinal disorders
Perforation, GI - colon
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
1.3%
1/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary - nose
|
0.00%
0/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Gastrointestinal disorders
Ulcer, GI - stomach
|
0.00%
0/76 • 5 years
|
3.4%
1/29 • 5 years
|
Other adverse events
| Measure |
Cohort A
n=76 participants at risk
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
|
Cohort B
n=29 participants at risk
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
85.5%
65/76 • 5 years
|
82.8%
24/29 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.1%
13/76 • 5 years
|
31.0%
9/29 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hand - foot
|
11.8%
9/76 • 5 years
|
6.9%
2/29 • 5 years
|
|
General disorders
Pain - muscle
|
36.8%
28/76 • 5 years
|
37.9%
11/29 • 5 years
|
|
General disorders
Pain - bone
|
32.9%
25/76 • 5 years
|
48.3%
14/29 • 5 years
|
|
General disorders
Pain - joint
|
25.0%
19/76 • 5 years
|
41.4%
12/29 • 5 years
|
|
General disorders
Pain - head/headache
|
25.0%
19/76 • 5 years
|
20.7%
6/29 • 5 years
|
|
General disorders
Pain - extremity - limb
|
21.1%
16/76 • 5 years
|
13.8%
4/29 • 5 years
|
|
General disorders
Pain - chest/thorax
|
14.5%
11/76 • 5 years
|
6.9%
2/29 • 5 years
|
|
General disorders
Pain - breast
|
11.8%
9/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
General disorders
Pain - back
|
10.5%
8/76 • 5 years
|
20.7%
6/29 • 5 years
|
|
General disorders
Pain - abdominal NOS
|
10.5%
8/76 • 5 years
|
6.9%
2/29 • 5 years
|
|
General disorders
Pain - pain NOS
|
6.6%
5/76 • 5 years
|
20.7%
6/29 • 5 years
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) - oral cavity
|
40.8%
31/76 • 5 years
|
27.6%
8/29 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
31.6%
24/76 • 5 years
|
24.1%
7/29 • 5 years
|
|
General disorders
Nausea
|
30.3%
23/76 • 5 years
|
41.4%
12/29 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
22.4%
17/76 • 5 years
|
20.7%
6/29 • 5 years
|
|
Gastrointestinal disorders
Dehydration
|
19.7%
15/76 • 5 years
|
24.1%
7/29 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
13.2%
10/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Gastrointestinal disorders
Heartburn
|
11.8%
9/76 • 5 years
|
6.9%
2/29 • 5 years
|
|
General disorders
Fatigue
|
61.8%
47/76 • 5 years
|
69.0%
20/29 • 5 years
|
|
General disorders
Fever
|
5.3%
4/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Cardiac disorders
Hypertension
|
38.2%
29/76 • 5 years
|
41.4%
12/29 • 5 years
|
|
Cardiac disorders
Left ventricular systolic function
|
17.1%
13/76 • 5 years
|
10.3%
3/29 • 5 years
|
|
Blood and lymphatic system disorders
Neutrophils
|
25.0%
19/76 • 5 years
|
17.2%
5/29 • 5 years
|
|
Blood and lymphatic system disorders
Leucocytes
|
22.4%
17/76 • 5 years
|
10.3%
3/29 • 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
13.2%
10/76 • 5 years
|
24.1%
7/29 • 5 years
|
|
Nervous system disorders
Neuropathy - sensory
|
23.7%
18/76 • 5 years
|
27.6%
8/29 • 5 years
|
|
Nervous system disorders
Dizziness
|
7.9%
6/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Nervous system disorders
Neuropathy - motor
|
6.6%
5/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Infections and infestations
Infection with normal ANC - skin (cellulites)
|
14.5%
11/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Infections and infestations
Infection with normal ANC - bladder (urinary)
|
7.9%
6/76 • 5 years
|
20.7%
6/29 • 5 years
|
|
Infections and infestations
Febrile neutropenia
|
5.3%
4/76 • 5 years
|
10.3%
3/29 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
9/76 • 5 years
|
10.3%
3/29 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.6%
5/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Metabolism and nutrition disorders
ALT
|
5.3%
4/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Metabolism and nutrition disorders
AST, SGOT
|
5.3%
4/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
21.1%
16/76 • 5 years
|
31.0%
9/29 • 5 years
|
|
General disorders
Hot flashes
|
19.7%
15/76 • 5 years
|
13.8%
4/29 • 5 years
|
|
Gastrointestinal disorders
Mucositis (clinical exam) - oral cavity
|
18.4%
14/76 • 5 years
|
17.2%
5/29 • 5 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
15.8%
12/76 • 5 years
|
24.1%
7/29 • 5 years
|
|
General disorders
Anorexia
|
15.8%
12/76 • 5 years
|
17.2%
5/29 • 5 years
|
|
Gastrointestinal disorders
Taste alteration
|
15.8%
12/76 • 5 years
|
13.8%
4/29 • 5 years
|
|
Psychiatric disorders
Mood alteration - depression
|
14.5%
11/76 • 5 years
|
17.2%
5/29 • 5 years
|
|
General disorders
Insomnia
|
13.2%
10/76 • 5 years
|
10.3%
3/29 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
11.8%
9/76 • 5 years
|
6.9%
2/29 • 5 years
|
|
Psychiatric disorders
Mood alteration - anxiety
|
11.8%
9/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
General disorders
Edema - limb
|
7.9%
6/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Gastrointestinal disorders
Gastritis
|
7.9%
6/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Eye disorders
Watery eye
|
6.6%
5/76 • 5 years
|
20.7%
6/29 • 5 years
|
|
General disorders
Weight loss
|
6.6%
5/76 • 5 years
|
10.3%
3/29 • 5 years
|
|
Investigations
Hyperglycemia
|
6.6%
5/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
6.6%
5/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Infections and infestations
Infection with normal ANC - sinus
|
6.6%
5/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Infections and infestations
Infection with unknown ANC - sinus
|
6.6%
5/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Infections and infestations
Infection with unknown ANC - upper airway NOS
|
6.6%
5/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
5.3%
4/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
4/76 • 5 years
|
3.4%
1/29 • 5 years
|
|
Infections and infestations
Infection with normal ANC - upper airway NOS
|
3.9%
3/76 • 5 years
|
6.9%
2/29 • 5 years
|
|
Infections and infestations
Infection with unknown ANC - bronchus
|
3.9%
3/76 • 5 years
|
6.9%
2/29 • 5 years
|
|
Eye disorders
Blurred vision
|
2.6%
2/76 • 5 years
|
10.3%
3/29 • 5 years
|
|
Gastrointestinal disorders
Hemorhoids
|
1.3%
1/76 • 5 years
|
17.2%
5/29 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
2/76 • 5 years
|
6.9%
2/29 • 5 years
|
|
Blood and lymphatic system disorders
Blood - Other (low HCT)
|
5.3%
4/76 • 5 years
|
0.00%
0/29 • 5 years
|
|
Reproductive system and breast disorders
Vaginitis
|
2.6%
2/76 • 5 years
|
6.9%
2/29 • 5 years
|
|
Infections and infestations
Infection - other- shingles
|
1.3%
1/76 • 5 years
|
6.9%
2/29 • 5 years
|
Additional Information
Director, Department of Site and Study Management
NSABP Foundation, Inc.
Phone: 1-800-270-3165
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60