Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa
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ClinicalTrials.gov Identifier: NCT01670500 |
Recruitment Status :
Active, not recruiting
First Posted : August 22, 2012
Results First Posted : August 3, 2020
Last Update Posted : May 25, 2022
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Breast Cancer |
Interventions |
Drug: Cisplatin Drug: Cyclophosphamide Drug: Doxorubicin |
Enrollment | 118 |
Recruitment Details | The trial was conducted at 13 academic centers and participants were recruited from these locations. Accrual occurred between January 2012 and January 2019. |
Pre-assignment Details |
Arm/Group Title | Doxorubicin-Cyclophosphamide | Cisplatin |
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Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4 Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses |
Cisplatin q 3 wk x 4 Cisplatin: administered intravenously every 3 weeks for 4 doses |
Period Title: Overall Study | ||
Started | 58 | 60 |
Completed [1] | 57 [2] | 60 [3] |
Not Completed | 1 | 0 |
Reason Not Completed | ||
Withdrawal by Subject | 1 | 0 |
[1]
Participants received allocated intervention
[2]
1 patient withdrew after 3 cycles; 5 patients received additional non-protocol chemo before surgery
[3]
4 pts received <4 cycles of assigned chemo; 2 pts received add'l non-protocol chemo before surgery
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Arm/Group Title | Doxorubicin-Cyclophosphamide | Cisplatin | Total | |
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Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4 Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses |
Cisplatin q 3 wk x 4 Cisplatin: administered intravenously every 3 weeks for 4 doses |
Total of all reporting groups | |
Overall Number of Baseline Participants | 58 | 60 | 118 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
44 (10) | 40 (9) | 42 (10) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
Female |
58 100.0%
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59 98.3%
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117 99.2%
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Male |
0 0.0%
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1 1.7%
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1 0.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
Hispanic or Latino |
7 12.1%
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8 13.3%
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15 12.7%
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Not Hispanic or Latino |
49 84.5%
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48 80.0%
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97 82.2%
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Unknown or Not Reported |
2 3.4%
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4 6.7%
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6 5.1%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
2 3.4%
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2 3.3%
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4 3.4%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
5 8.6%
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7 11.7%
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12 10.2%
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White |
44 75.9%
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43 71.7%
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87 73.7%
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More than one race |
2 3.4%
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3 5.0%
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5 4.2%
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Unknown or Not Reported |
5 8.6%
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5 8.3%
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10 8.5%
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BRCA status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
BRCA 1 |
37 63.8%
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44 73.3%
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81 68.6%
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BRCA 2 |
20 34.5%
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15 25.0%
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35 29.7%
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BRCA 1 and BRCA 2 |
1 1.7%
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1 1.7%
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2 1.7%
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[1]
Measure Description: Eligible patients had a germline pathogenic or likely pathogenic variant (i.e. mutation) in BRCA1 or BRCA2; genetic testing was not performed as part of the trial, but known genetic status was required for eligibility
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Tumor size by imaging
Median (Inter-Quartile Range) Unit of measure: Centimeters |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
2
(2 to 4)
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3
(2 to 4)
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2
(2 to 4)
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T Stage (Tumor Size)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
T1 |
17 29.3%
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12 20.0%
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29 24.6%
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T2 |
31 53.4%
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35 58.3%
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66 55.9%
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T3 |
10 17.2%
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12 20.0%
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22 18.6%
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unknown |
0 0.0%
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1 1.7%
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1 0.8%
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[1]
Measure Description:
Per National Cancer Institute (NCI) definition, T describes the size of the tumor and any spread of cancer into nearby tissue. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues. T1: The tumor in the breast is 20 millimeters (mm) or smaller in size at its widest area. T2: The tumor is larger than 20 mm but not larger than 50 mm. T3: The tumor is larger than 50 mm. |
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N stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
N0 |
34 58.6%
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31 51.7%
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65 55.1%
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N1 |
19 32.8%
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24 40.0%
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43 36.4%
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N2 |
2 3.4%
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2 3.3%
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4 3.4%
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N3 |
3 5.2%
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3 5.0%
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6 5.1%
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[1]
Measure Description:
Per the National Cancer Institute Definition: N stage refers to the number of nearby lymph nodes that have cancer. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer. |
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Node status: biopsy before chemotherapy
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
positive |
24 41.4%
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29 48.3%
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53 44.9%
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negative |
34 58.6%
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31 51.7%
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65 55.1%
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Stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
I |
15 25.9%
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8 13.3%
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23 19.5%
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II |
34 58.6%
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40 66.7%
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74 62.7%
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III |
9 15.5%
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12 20.0%
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21 17.8%
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[1]
Measure Description:
Per the National Cancer Institute Definitions: Stage of Cancer. For Stage I, II, III, cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues. |
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Estrogen Receptor (ER)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
Positive (>/= 1%) |
20 34.5%
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20 33.3%
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40 33.9%
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Negative (< 1%) |
38 65.5%
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40 66.7%
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78 66.1%
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Hormone receptor 1% cutoff
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
Triple Negative Breast Cancer (ER & PR < 1%) |
36 62.1%
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40 66.7%
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76 64.4%
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ER+ or PR+ |
22 37.9%
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20 33.3%
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42 35.6%
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[1]
Measure Description: ER= estrogen receptor; PR= progesterone receptor
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Histology
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
Invasive ductal |
52 89.7%
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57 95.0%
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109 92.4%
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Invasive lobular |
2 3.4%
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2 3.3%
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4 3.4%
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Mixed |
3 5.2%
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1 1.7%
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4 3.4%
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Other |
1 1.7%
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0 0.0%
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1 0.8%
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Pre-chemotherapy tumor grade
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
1 |
1 1.7%
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2 3.3%
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3 2.5%
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2 |
12 20.7%
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11 18.3%
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23 19.5%
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3 |
45 77.6%
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46 76.7%
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91 77.1%
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unknown |
0 0.0%
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1 1.7%
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1 0.8%
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[1]
Measure Description:
Per the National Cancer Institute Definition: Tumor grade is description of tumor based on how abnormal the tumor cells and tumor tissue look under a microscope. In general, tumors are graded as 1, 2, 3, or 4, depending on the amount of abnormality. In Grade 1 tumors, the tumor cells and organization of the tumor tissue appear close to normal. These tumors tend to grow and spread slowly. In contrast, the cells and tissue of Grade 3 and Grade 4 tumors do not look like normal cells and tissue. Grade 3 and Grade 4 tumors tend to grow rapidly and spread faster than tumors with a lower grade. |
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Lymphovascular invasion
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
Present |
11 19.0%
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12 20.0%
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23 19.5%
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Absent |
47 81.0%
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48 80.0%
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95 80.5%
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lymphocytic infiltrate
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 60 participants | 118 participants | |
moderate/marked |
22 37.9%
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21 35.0%
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43 36.4%
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absent/scant |
33 56.9%
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36 60.0%
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69 58.5%
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unknown |
3 5.2%
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3 5.0%
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6 5.1%
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Stromal TILs
[1] [2] Median (Inter-Quartile Range) Unit of measure: Percentage of stromal TILs |
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Number Analyzed | 53 participants | 56 participants | 109 participants | |
10
(1 to 20)
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10
(3 to 30)
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10
(1 to 20)
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[1]
Measure Description:
TILs= tumor infiltrating lymphocytes The pre-chemotherapy clinical biopsy was assessed for tumor infiltrating lymphocytes. [2]
Measure Analysis Population Description: Stromal TILS missing for 5 in Doxorubicin-Cyclophosphamide arm and 4 in the Cisplatin arm
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Name/Title: | Project Manager |
Organization: | DFCI |
Phone: | 617-632-2257 |
EMail: | CTOPM@dfci.harvard.edu |
Responsible Party: | Nadine Tung, MD, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT01670500 |
Other Study ID Numbers: |
12-258 |
First Submitted: | August 16, 2012 |
First Posted: | August 22, 2012 |
Results First Submitted: | June 12, 2020 |
Results First Posted: | August 3, 2020 |
Last Update Posted: | May 25, 2022 |