Trial Outcomes & Findings for Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores (NCT NCT00832338)
NCT ID: NCT00832338
Last Updated: 2017-08-31
Results Overview
Patients were assessed for surgery after 6 cycles of TC (18 weeks). Pathologic stage was determined based on size of tumor and degree of lymph node involvement at the time of surgery, whereas clinical stage pre-operatively was determined by clinical assessment and imaging. If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
At time of definitive surgery
Results posted on
2017-08-31
Participant Flow
Patients were recruited from April 2009 to October 2015 at Winship Cancer Institute of Emory University, Emory University Hospital Midtown, and Grady Memorial Hospital.
Participant milestones
| Measure |
Docetaxel With Cytoxan
Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores
Baseline characteristics by cohort
| Measure |
Docetaxel With Cytoxan
n=23 Participants
Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.
|
|---|---|
|
Age, Continuous
|
54.91 years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 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
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of definitive surgeryPopulation: Staging information was not collected for two patients.
Patients were assessed for surgery after 6 cycles of TC (18 weeks). Pathologic stage was determined based on size of tumor and degree of lymph node involvement at the time of surgery, whereas clinical stage pre-operatively was determined by clinical assessment and imaging. If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists.
Outcome measures
| Measure |
Docetaxel With Cytoxan
n=21 Participants
Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.
|
|---|---|
|
Pathologic Response to Pre-operative Docetaxel and Cytoxan (TC)
Downstaged
|
12 Participants
|
|
Pathologic Response to Pre-operative Docetaxel and Cytoxan (TC)
Stable
|
4 Participants
|
|
Pathologic Response to Pre-operative Docetaxel and Cytoxan (TC)
Upstaged
|
5 Participants
|
Adverse Events
Docetaxel With Cytoxan
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel With Cytoxan
n=23 participants at risk
Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.
|
|---|---|
|
Infections and infestations
Febrile neutropenia
|
4.3%
1/23
|
Other adverse events
| Measure |
Docetaxel With Cytoxan
n=23 participants at risk
Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.
|
|---|---|
|
Cardiac disorders
Tachycardia
|
4.3%
1/23
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23
|
|
General disorders
Fever
|
4.3%
1/23
|
|
Nervous system disorders
Syncope
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Increased creatinine
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.7%
2/23
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
1/23
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.3%
1/23
|
|
Reproductive system and breast disorders
Irregular menstruation
|
4.3%
1/23
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.3%
1/23
|
|
General disorders
Chills
|
8.7%
2/23
|
|
Gastrointestinal disorders
Colitis
|
4.3%
1/23
|
|
General disorders
Weight gain
|
8.7%
2/23
|
|
General disorders
Fatigue
|
69.6%
16/23
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
8.7%
2/23
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
26.1%
6/23
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
8.7%
2/23
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
21.7%
5/23
|
|
Eye disorders
Watery eyes
|
13.0%
3/23
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
1/23
|
|
General disorders
Abdominal pain
|
4.3%
1/23
|
|
Nervous system disorders
Memory impairment
|
4.3%
1/23
|
|
Gastrointestinal disorders
Anorexia
|
13.0%
3/23
|
|
Nervous system disorders
Sensory peripheral neuropathy
|
52.2%
12/23
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
34.8%
8/23
|
|
Gastrointestinal disorders
Nausea
|
17.4%
4/23
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23
|
|
Gastrointestinal disorders
Diarrhea
|
26.1%
6/23
|
|
Gastrointestinal disorders
Constipation
|
17.4%
4/23
|
|
Blood and lymphatic system disorders
Lower extremity edema
|
34.8%
8/23
|
|
Gastrointestinal disorders
Oral mucositis
|
17.4%
4/23
|
|
Gastrointestinal disorders
Dysgeusia
|
26.1%
6/23
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
34.8%
8/23
|
|
General disorders
Insomnia
|
21.7%
5/23
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.1%
6/23
|
|
Psychiatric disorders
Anxiety
|
21.7%
5/23
|
|
Psychiatric disorders
Depression
|
13.0%
3/23
|
|
Psychiatric disorders
Mood swings
|
4.3%
1/23
|
|
Immune system disorders
Allergic reaction
|
4.3%
1/23
|
|
Nervous system disorders
Headache
|
21.7%
5/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.1%
6/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place