Trial Outcomes & Findings for Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer (NCT NCT00209092)
NCT ID: NCT00209092
Last Updated: 2015-03-27
Results Overview
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast. Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%) Stable disease (SD): No decrease or \<25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions. Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
1 year
Results posted on
2015-03-27
Participant Flow
Participant milestones
| Measure |
Arm A:Sequential Therapy
Docetaxel will be given at 100mg/m\^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
|
Arm B:Concurrent Therapy
Docetaxel will be given at 50mg/m\^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
17
|
24
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
Arm A:Sequential Therapy
Docetaxel will be given at 100mg/m\^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
|
Arm B:Concurrent Therapy
Docetaxel will be given at 50mg/m\^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
|
|---|---|---|
|
Overall Study
Progression of disease
|
7
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A:Sequential Therapy
n=25 Participants
Docetaxel will be given at 100mg/m\^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
|
Arm B:Concurrent Therapy
n=26 Participants
Docetaxel will be given at 50mg/m\^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
|
50.8 participants
n=5 Participants
|
49.8 participants
n=7 Participants
|
50.3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPathologic complete response (pCR): Absence of invasive breast cancer in the breast. Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%) Stable disease (SD): No decrease or \<25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions. Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.
Outcome measures
| Measure |
Arm A:Sequential Therapy
n=25 Participants
Docetaxel will be given at 100mg/m\^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
|
Arm B:Concurrent Therapy
n=26 Participants
Docetaxel will be given at 50mg/m\^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
|
|---|---|---|
|
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
Pathologic Complete Response-Overall population
|
2 participants
|
3 participants
|
|
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
Overall Clinical Response
|
15 participants
|
23 participants
|
|
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
Stable disease
|
3 participants
|
1 participants
|
|
Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
Progressive Disease
|
7 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of Patients remained alive and relapse free
Outcome measures
| Measure |
Arm A:Sequential Therapy
n=24 Participants
Docetaxel will be given at 100mg/m\^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
|
Arm B:Concurrent Therapy
n=26 Participants
Docetaxel will be given at 50mg/m\^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
|
|---|---|---|
|
Long Term Follow up Data on Recurrence and Survival
|
19 participants
|
21 participants
|
Adverse Events
Arm A:Sequential Therapy
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Arm B:Concurrent Therapy
Serious events: 11 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A:Sequential Therapy
n=25 participants at risk
Docetaxel will be given at 100mg/m\^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
|
Arm B:Concurrent Therapy
n=26 participants at risk
Docetaxel will be given at 50mg/m\^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25
|
3.8%
1/26
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.0%
3/25
|
11.5%
3/26
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/25
|
3.8%
1/26
|
|
Skin and subcutaneous tissue disorders
Hand and Foot Syndrome
|
4.0%
1/25
|
3.8%
1/26
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/25
|
3.8%
1/26
|
|
General disorders
Fatigue
|
4.0%
1/25
|
0.00%
0/26
|
|
Hepatobiliary disorders
Liver Tests
|
0.00%
0/25
|
3.8%
1/26
|
|
Nervous system disorders
Syncope
|
0.00%
0/25
|
3.8%
1/26
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/25
|
3.8%
1/26
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/25
|
3.8%
1/26
|
Other adverse events
| Measure |
Arm A:Sequential Therapy
n=25 participants at risk
Docetaxel will be given at 100mg/m\^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
|
Arm B:Concurrent Therapy
n=26 participants at risk
Docetaxel will be given at 50mg/m\^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
56.0%
14/25
|
38.5%
10/26
|
|
Nervous system disorders
Neuropathy
|
56.0%
14/25
|
53.8%
14/26
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
2/25
|
30.8%
8/26
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Syndrome
|
56.0%
14/25
|
69.2%
18/26
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
10/25
|
19.2%
5/26
|
|
General disorders
Fatigue
|
80.0%
20/25
|
65.4%
17/26
|
|
Gastrointestinal disorders
Nausea
|
36.0%
9/25
|
42.3%
11/26
|
|
General disorders
Anorexia
|
20.0%
5/25
|
19.2%
5/26
|
|
Musculoskeletal and connective tissue disorders
Myalgias/Arthralgias
|
48.0%
12/25
|
34.6%
9/26
|
|
Endocrine disorders
Hyperglycemia
|
64.0%
16/25
|
61.5%
16/26
|
|
Hepatobiliary disorders
Liver Tests
|
40.0%
10/25
|
34.6%
9/26
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
56.0%
14/25
|
50.0%
13/26
|
|
Gastrointestinal disorders
Muscositis
|
40.0%
10/25
|
50.0%
13/26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place