Trial Outcomes & Findings for Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients (NCT NCT00206518)
NCT ID: NCT00206518
Last Updated: 2020-07-28
Results Overview
The patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as: 1. Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR) 2. Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR) 3. Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively \> 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively \< 25% therapeutic effect OR Grade 4 4. No or few modification of tumoral appearance (pNR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
10 years
Results posted on
2020-07-28
Participant Flow
Participant milestones
| Measure |
A: Taxotere/Docetaxel
Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
|
B: AC Adriamycin/Cytoxan
In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
84
|
|
Overall Study
COMPLETED
|
73
|
78
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
A: Taxotere/Docetaxel
Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
|
B: AC Adriamycin/Cytoxan
In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
4
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
A: Taxotere/Docetaxel
n=83 Participants
Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
|
B: AC Adriamycin/Cytoxan
n=84 Participants
In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=50 years
|
56 participants
n=93 Participants
|
49 participants
n=4 Participants
|
105 participants
n=27 Participants
|
|
Age, Customized
>50 years
|
27 participants
n=93 Participants
|
35 participants
n=4 Participants
|
62 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
167 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
21 participants
n=93 Participants
|
27 participants
n=4 Participants
|
48 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
35 participants
n=93 Participants
|
34 participants
n=4 Participants
|
69 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
24 participants
n=93 Participants
|
18 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=93 Participants
|
5 participants
n=4 Participants
|
8 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 10 yearsThe patients' pathological response were assessed using Chevalier's system which graded the responses into Chevalier 1, 2, 3A, 3B, 3C, 3D, and 4, defined as: 1. Disappearance of all tumor either on macroscopic or microscopic assessment in both the breast and LN (pCR) 2. Presence of in situ carcinoma in the breast. No invasive tumor in breast and no tumor in LN (pCR) 3. Presence of invasive cancer with stromal alteration such as sclerosis or fibrosis (pPR) 3A: Subjectively \> 75% therapeutic effect 3B: Subjectively between 50% - 75% therapeutic effect 3C: Subjectively between 25% - 50% therapeutic effect 3D: Subjectively \< 25% therapeutic effect OR Grade 4 4. No or few modification of tumoral appearance (pNR).
Outcome measures
| Measure |
A: Taxotere/Docetaxel
n=83 Participants
Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
|
B: AC Adriamycin/Cytoxan
n=84 Participants
In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan
|
|---|---|---|
|
Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)
1
|
3 participants
|
9 participants
|
|
Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)
2
|
2 participants
|
1 participants
|
|
Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)
3A
|
18 participants
|
15 participants
|
|
Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)
3B
|
15 participants
|
18 participants
|
|
Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)
3C
|
18 participants
|
15 participants
|
|
Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)
3D
|
10 participants
|
8 participants
|
|
Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)
4
|
3 participants
|
0 participants
|
|
Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)
N/A
|
14 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 10 yearsData associated with relapse and progression will be obtained over the course of 10 years. Relapse/progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
A: Taxotere/Docetaxel
n=83 Participants
Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
|
B: AC Adriamycin/Cytoxan
n=84 Participants
In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan
|
|---|---|---|
|
Disease Relapse
relapsed
|
24 participants
|
25 participants
|
|
Disease Relapse
not relapsed
|
59 participants
|
59 participants
|
SECONDARY outcome
Timeframe: 10 yearsOutcome measures
| Measure |
A: Taxotere/Docetaxel
n=83 Participants
Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
|
B: AC Adriamycin/Cytoxan
n=84 Participants
In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan
|
|---|---|---|
|
Overall Survival
deceased
|
16 participants
|
19 participants
|
|
Overall Survival
alive
|
67 participants
|
65 participants
|
Adverse Events
A: Taxotere/Docetaxel
Serious events: 12 serious events
Other events: 13 other events
Deaths: 0 deaths
B: AC Adriamycin/Cytoxan
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: Taxotere/Docetaxel
n=83 participants at risk
Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
|
B: AC Adriamycin/Cytoxan
n=84 participants at risk
In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/83
|
1.2%
1/84 • Number of events 1
|
|
Immune system disorders
ALLERGIC/REACTION
|
1.2%
1/83 • Number of events 1
|
0.00%
0/84
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
9.6%
8/83 • Number of events 12
|
3.6%
3/84 • Number of events 6
|
|
General disorders
FEVER
|
2.4%
2/83 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/83
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
INFECTION
|
4.8%
4/83 • Number of events 6
|
1.2%
1/84 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/83
|
1.2%
1/84 • Number of events 2
|
Other adverse events
| Measure |
A: Taxotere/Docetaxel
n=83 participants at risk
Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
Taxotere/Docetaxel: Taxotere
doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
|
B: AC Adriamycin/Cytoxan
n=84 participants at risk
In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
Adriamycin/Cytoxan: Adriamycin/Cytoxan
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
15.7%
13/83 • Number of events 20
|
3.6%
3/84 • Number of events 14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place