Trial Outcomes & Findings for Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer (NCT NCT00343512)
NCT ID: NCT00343512
Last Updated: 2012-04-27
Results Overview
whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
3 month
Results posted on
2012-04-27
Participant Flow
This study enrolled patients from February 2004 to September 2007.
A total of 39 people were consented, one of which was ineligible. Four patients withdrew from the study before beginning treatment.
Participant milestones
| Measure |
Therapeutic Intervention
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Therapeutic Intervention
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
Baseline characteristics by cohort
| Measure |
Therapeutic Intervention
n=34 Participants
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
47 years
STANDARD_DEVIATION 1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 monthwhether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)
Outcome measures
| Measure |
Therapeutic Intervention
n=34 Participants
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
|
|---|---|
|
Number Participants to Achieve Pathologic Complete Response
pCR: Yes
|
5 participants
|
|
Number Participants to Achieve Pathologic Complete Response
pCR: No
|
29 participants
|
SECONDARY outcome
Timeframe: Through 30 days after completion of treatmentNot all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria
Outcome measures
| Measure |
Therapeutic Intervention
n=12 Participants
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
|
|---|---|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
No. patients with worst-grade toxicity 1
|
5 participants
|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
No. patients with worst-grade toxicity 2
|
8 participants
|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
No. patients with worst-grade toxicity 3
|
11 participants
|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
No. patients with worst-grade toxicity 4
|
1 participants
|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
No. patients with worst-grade toxicity 5
|
0 participants
|
SECONDARY outcome
Timeframe: At screening, 8 weeks and at surgery (within 14-21 days)Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Outcome measures
| Measure |
Therapeutic Intervention
n=18 Participants
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
|
|---|---|
|
Tumor Response as Measured by Ultrasound
Progressive Disease
|
1 participants
|
|
Tumor Response as Measured by Ultrasound
Stable Disease
|
1 participants
|
|
Tumor Response as Measured by Ultrasound
Complete Response
|
5 participants
|
|
Tumor Response as Measured by Ultrasound
Partial Response
|
11 participants
|
Adverse Events
Therapeutic Intervention
Serious events: 9 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Therapeutic Intervention
n=32 participants at risk
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
1/32 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
1/32 • Number of events 1
|
|
Cardiac disorders
Chest Pain
|
9.4%
3/32 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Fatigue
|
12.5%
4/32 • Number of events 5
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Number of events 1
|
|
Vascular disorders
Hematoma
|
3.1%
1/32 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
3.1%
1/32 • Number of events 1
|
|
Investigations
Neutrophil count decrease
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Infection
|
18.8%
6/32 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
6.2%
2/32 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
pain, right shoulder
|
3.1%
1/32 • Number of events 1
|
|
Investigations
hemoglobin increased
|
18.8%
6/32 • Number of events 7
|
|
General disorders
fever
|
6.2%
2/32 • Number of events 2
|
|
General disorders
edema, arm
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
3.1%
1/32 • Number of events 2
|
|
Vascular disorders
hypertension
|
3.1%
1/32 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
alopecia
|
3.1%
1/32 • Number of events 2
|
|
Injury, poisoning and procedural complications
bruising
|
3.1%
1/32 • Number of events 2
|
|
Endocrine disorders
hypothyroidism
|
3.1%
1/32 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
6.2%
2/32 • Number of events 3
|
|
Metabolism and nutrition disorders
hyperglycemia
|
6.2%
2/32 • Number of events 3
|
|
Metabolism and nutrition disorders
hypercholesterolemia
|
3.1%
1/32 • Number of events 1
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
3.1%
1/32 • Number of events 1
|
|
Vascular disorders
acute vascular leak syndrome
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
nail changes
|
3.1%
1/32 • Number of events 1
|
|
Investigations
alkaline phosphatase increase
|
3.1%
1/32 • Number of events 1
|
|
Nervous system disorders
neuropathy
|
6.2%
2/32 • Number of events 2
|
|
Cardiac disorders
sinus tachacardia
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
3.1%
1/32 • Number of events 1
|
|
Investigations
weight loss
|
3.1%
1/32 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
3.1%
1/32 • Number of events 1
|
Other adverse events
| Measure |
Therapeutic Intervention
n=32 participants at risk
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
|
|---|---|
|
Immune system disorders
Allergic reaction
|
6.2%
2/32 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
6.2%
2/32 • Number of events 2
|
|
Investigations
Alkaline Phosphatase
|
18.8%
6/32 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
59.4%
19/32 • Number of events 23
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
15.6%
5/32 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
9.4%
3/32 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
25.0%
8/32 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
2/32 • Number of events 2
|
|
Metabolism and nutrition disorders
AST, SGOT
|
6.2%
2/32 • Number of events 2
|
|
Blood and lymphatic system disorders
Blood, bone marrow
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32 • Number of events 3
|
|
Psychiatric disorders
Depression
|
15.6%
5/32 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
9.4%
3/32 • Number of events 3
|
|
Eye disorders
Dry eye syndrome
|
12.5%
4/32 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dsypnea
|
18.8%
6/32 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia, heartburn
|
9.4%
3/32 • Number of events 3
|
|
General disorders
Edema
|
12.5%
4/32 • Number of events 7
|
|
General disorders
Fatigue
|
68.8%
22/32 • Number of events 25
|
|
Vascular disorders
Flushes
|
25.0%
8/32 • Number of events 9
|
|
Metabolism and nutrition disorders
Glucose, serum-high
|
21.9%
7/32
|
|
Investigations
Hemoglobin
|
43.8%
14/32 • Number of events 15
|
|
Vascular disorders
Hemorrhage
|
15.6%
5/32 • Number of events 5
|
|
Infections and infestations
Infection
|
31.2%
10/32 • Number of events 11
|
|
Psychiatric disorders
Insomnia
|
21.9%
7/32 • Number of events 7
|
|
Reproductive system and breast disorders
Irregular menses
|
25.0%
8/32 • Number of events 8
|
|
Blood and lymphatic system disorders
Leukocytes,
|
6.2%
2/32 • Number of events 2
|
|
Psychiatric disorders
Memory impairment
|
9.4%
3/32 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, legs
|
15.6%
5/32 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Musculoskelatal stiffness
|
9.4%
3/32 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
53.1%
17/32 • Number of events 17
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Number of events 3
|
|
Nervous system disorders
Neuropathy
|
56.2%
18/32 • Number of events 25
|
|
General disorders
Pain - breast
|
15.6%
5/32 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain, bone
|
15.6%
5/32 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain, extermity limb
|
28.1%
9/32 • Number of events 9
|
|
General disorders
Pain, headache
|
12.5%
4/32 • Number of events 4
|
|
Metabolism and nutrition disorders
Potassium, serum-low
|
12.5%
4/32 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus, itching
|
6.2%
2/32 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin dry
|
25.0%
8/32 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Skin reaction, hand-foot
|
12.5%
4/32 • Number of events 6
|
|
General disorders
Sweating
|
9.4%
3/32 • Number of events 3
|
|
Nervous system disorders
Taste alteration, dysgeusia
|
31.2%
10/32 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32 • Number of events 2
|
|
Eye disorders
Watery eye, tearing
|
31.2%
10/32 • Number of events 11
|
|
Investigations
Weight gain
|
12.5%
4/32 • Number of events 4
|
|
Metabolism and nutrition disorders
obesity
|
6.2%
2/32 • Number of events 2
|
|
Investigations
Weight loss
|
9.4%
3/32 • Number of events 5
|
Additional Information
Bapsi Chak, M.D.
Vanderbilt-Ingram Cancer Center
Phone: 615-322-2555
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place