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Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

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ClinicalTrials.gov Identifier: NCT00343512
Recruitment Status : Terminated (closed due to competing neoadjuvant studies for a small patient population)
First Posted : June 23, 2006
Results First Posted : November 9, 2010
Last Update Posted : April 27, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bapsi Chak, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: docetaxel
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Procedure: biopsy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Enrollment 34

Recruitment Details This study enrolled patients from February 2004 to September 2007.
Pre-assignment Details A total of 39 people were consented, one of which was ineligible. Four patients withdrew from the study before beginning treatment.
Arm/Group Title Therapeutic Intervention
Hide Arm/Group Description Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
Period Title: Overall Study
Started 34
Completed 32
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Therapeutic Intervention
Hide Arm/Group Description Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
47  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
34
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Number Participants to Achieve Pathologic Complete Response
Hide Description 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)
Time Frame 3 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
Hide Arm/Group Description:
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: participants
pCR: Yes 5
pCR: No 29
2.Secondary Outcome
Title Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
Hide Description Not 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
Time Frame Through 30 days after completion of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
No. patients with worst-grade toxicity 1 5
No. patients with worst-grade toxicity 2 8
No. patients with worst-grade toxicity 3 11
No. patients with worst-grade toxicity 4 1
No. patients with worst-grade toxicity 5 0
3.Secondary Outcome
Title Tumor Response as Measured by Ultrasound
Hide Description 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.
Time Frame At screening, 8 weeks and at surgery (within 14-21 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
Hide Arm/Group Description:
Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
Complete Response 5
Progressive Disease 1
Stable Disease 1
Partial Response 11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Therapeutic Intervention
Hide Arm/Group Description Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
All-Cause Mortality
Therapeutic Intervention
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Therapeutic Intervention
Affected / at Risk (%) # Events
Total   9/32 (28.13%)    
Blood and lymphatic system disorders   
Anemia  1/32 (3.13%)  1
Febrile neutropenia  1/32 (3.13%)  1
Cardiac disorders   
Chest Pain  3/32 (9.38%)  4
sinus tachacardia  1/32 (3.13%)  1
Endocrine disorders   
hypothyroidism  1/32 (3.13%)  2
Gastrointestinal disorders   
Diarrhea  2/32 (6.25%)  2
Vomiting  2/32 (6.25%)  2
nausea  2/32 (6.25%)  3
General disorders   
Fatigue  4/32 (12.50%)  5
fever  2/32 (6.25%)  2
edema, arm  1/32 (3.13%)  1
Infections and infestations   
Infection [1]  6/32 (18.75%)  6
Injury, poisoning and procedural complications   
bruising  1/32 (3.13%)  2
Investigations   
Neutrophil count decrease  1/32 (3.13%)  1
hemoglobin increased  6/32 (18.75%)  7
alkaline phosphatase increase  1/32 (3.13%)  1
weight loss  1/32 (3.13%)  1
Metabolism and nutrition disorders   
Anorexia  1/32 (3.13%)  1
Dehydration  1/32 (3.13%)  1
hyperglycemia  2/32 (6.25%)  3
hypercholesterolemia  1/32 (3.13%)  1
hypertriglyceridemia  1/32 (3.13%)  1
Musculoskeletal and connective tissue disorders   
Muscle pain  1/32 (3.13%)  1
Weakness  2/32 (6.25%)  2
pain, right shoulder  1/32 (3.13%)  1
Nervous system disorders   
neuropathy  2/32 (6.25%)  2
Respiratory, thoracic and mediastinal disorders   
dyspnea  1/32 (3.13%)  2
pneumothorax  1/32 (3.13%)  1
cough  1/32 (3.13%)  1
Skin and subcutaneous tissue disorders   
alopecia  1/32 (3.13%)  2
nail changes  1/32 (3.13%)  1
Vascular disorders   
Hematoma  1/32 (3.13%)  1
hypertension  1/32 (3.13%)  2
acute vascular leak syndrome  1/32 (3.13%)  1
[1]
possible port infections, dental infection
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Therapeutic Intervention
Affected / at Risk (%) # Events
Total   27/32 (84.38%)    
Blood and lymphatic system disorders   
Blood, bone marrow  2/32 (6.25%)  2
Leukocytes,  2/32 (6.25%)  2
Eye disorders   
Dry eye syndrome  4/32 (12.50%)  4
Watery eye, tearing  10/32 (31.25%)  11
Gastrointestinal disorders   
Constipation  2/32 (6.25%)  2
Diarrhea  3/32 (9.38%)  3
Dyspepsia, heartburn  3/32 (9.38%)  3
Nausea  3/32 (9.38%)  3
Vomiting  2/32 (6.25%)  2
General disorders   
Edema  4/32 (12.50%)  7
Fatigue  22/32 (68.75%)  25
Pain - breast  5/32 (15.63%)  5
Pain, headache  4/32 (12.50%)  4
Sweating  3/32 (9.38%)  3
Immune system disorders   
Allergic reaction  2/32 (6.25%)  7
Infections and infestations   
Infection  10/32 (31.25%)  11
Investigations   
Alkaline Phosphatase  6/32 (18.75%)  6
Hemoglobin  14/32 (43.75%)  15
Weight gain  4/32 (12.50%)  4
Weight loss  3/32 (9.38%)  5
Metabolism and nutrition disorders   
ALT, SGPT  5/32 (15.63%)  5
Anorexia  3/32 (9.38%)  3
AST, SGOT  2/32 (6.25%)  2
Glucose, serum-high  7/32 (21.88%) 
Potassium, serum-low  4/32 (12.50%)  4
obesity  2/32 (6.25%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  2/32 (6.25%)  2
Muscle weakness, legs  5/32 (15.63%)  8
Musculoskelatal stiffness  3/32 (9.38%)  3
Pain, bone  5/32 (15.63%)  5
Pain, extermity limb  9/32 (28.13%)  9
Nervous system disorders   
Neuropathy  18/32 (56.25%)  25
Taste alteration, dysgeusia  10/32 (31.25%)  10
Psychiatric disorders   
Anxiety  8/32 (25.00%)  10
Depression  5/32 (15.63%)  6
Insomnia  7/32 (21.88%)  7
Memory impairment  3/32 (9.38%)  3
Reproductive system and breast disorders   
Irregular menses  8/32 (25.00%)  8
Respiratory, thoracic and mediastinal disorders   
Allergic Rhinitis  2/32 (6.25%)  2
Cough  2/32 (6.25%)  3
Dsypnea  6/32 (18.75%)  6
Skin and subcutaneous tissue disorders   
Alopecia  19/32 (59.38%)  23
Nail changes  17/32 (53.13%)  17
Pruritus, itching  2/32 (6.25%)  3
Skin dry  8/32 (25.00%)  9
Skin reaction, hand-foot  4/32 (12.50%)  6
Vascular disorders   
Flushes  8/32 (25.00%)  9
Hemorrhage  5/32 (15.63%)  5
All adverse events have been included in the "other adverse event" section. They are not differentiated by causality (eg. related to disease, con-meds).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Bapsi Chak, M.D.
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-322-2555
Responsible Party: Bapsi Chak, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00343512     History of Changes
Other Study ID Numbers: VICC BRE 0368
VICC-BRE-0368
VICC-11239
First Submitted: June 22, 2006
First Posted: June 23, 2006
Results First Submitted: October 11, 2010
Results First Posted: November 9, 2010
Last Update Posted: April 27, 2012