S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00127205 |
Recruitment Status :
Active, not recruiting
First Posted : August 5, 2005
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2020
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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: clodronate disodium Drug: ibandronate sodium Drug: zoledronic acid |
Enrollment | 6097 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm I Zoledronate | Arm II Clodronate | Arm III Ibandronate |
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Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years. zoledronic acid: Given IV |
Patients receive oral clodronate once daily for 35 months. clodronate disodium: Given orally |
Patients receive oral ibandronate once daily for 35 months. ibandronate sodium: Given orally |
Period Title: Overall Study | |||
Started | 2262 | 2268 | 1567 |
Completed | 1427 | 1288 | 950 |
Not Completed | 835 | 980 | 617 |
Reason Not Completed | |||
Adverse Event | 228 | 386 | 272 |
Death | 8 | 6 | 6 |
Withdrawal by Subject | 318 | 308 | 172 |
Other-non protocol specified | 141 | 129 | 77 |
Under Review | 13 | 21 | 6 |
Progression | 127 | 130 | 84 |
Arm/Group Title | Arm I Zoledronate | Arm II Clodronate | Arm III Ibandronate | Total | |
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Patients receive zoledronate IV over 15 minutes once a month for 6 months and then once every 3 months for 2.5 years. zoledronic acid: Given IV |
Patients receive oral clodronate once daily for 35 months. clodronate disodium: Given orally |
Patients receive oral ibandronate once daily for 35 months. ibandronate sodium: Given orally |
Total of all reporting groups | |
Overall Number of Baseline Participants | 2231 | 2235 | 1552 | 6018 | |
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Only eligible patients are included in the analysis.
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants | |
53.0
(24.8 to 85.7)
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52.6
(21.2 to 86.1)
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52.7
(26.1 to 85.8)
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52.7
(21.2 to 86.1)
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Age, Categorized | Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants |
Age < 55 |
1270 56.9%
|
1304 58.3%
|
894 57.6%
|
3468 57.6%
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Age >= 55 |
961 43.1%
|
931 41.7%
|
658 42.4%
|
2550 42.4%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants | |
Female |
2231 100.0%
|
2235 100.0%
|
1552 100.0%
|
6018 100.0%
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|
Male |
0 0.0%
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0 0.0%
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0 0.0%
|
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants | |
American Indian or Alaska Native |
12 0.5%
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8 0.4%
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4 0.3%
|
24 0.4%
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|
Asian |
70 3.1%
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90 4.0%
|
57 3.7%
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217 3.6%
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Native Hawaiian or Other Pacific Islander |
2 0.1%
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2 0.1%
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3 0.2%
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7 0.1%
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Black or African American |
129 5.8%
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118 5.3%
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85 5.5%
|
332 5.5%
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White |
1975 88.5%
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1976 88.4%
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1374 88.5%
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5325 88.5%
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More than one race |
12 0.5%
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5 0.2%
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2 0.1%
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19 0.3%
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|
Unknown or Not Reported |
31 1.4%
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36 1.6%
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27 1.7%
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94 1.6%
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Nodal Status
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants |
Negative |
1089 48.8%
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1152 51.5%
|
784 50.5%
|
3025 50.3%
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|
1~3 |
722 32.4%
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685 30.6%
|
489 31.5%
|
1896 31.5%
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>=4 |
404 18.1%
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385 17.2%
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267 17.2%
|
1056 17.5%
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ER/PR
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants |
Negative (ER-, PR-) |
480 21.5%
|
487 21.8%
|
319 20.6%
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1286 21.4%
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Positive (ER+ or PR+) |
1747 78.3%
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1747 78.2%
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1231 79.3%
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4725 78.5%
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HER2 status
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants |
HER2 negative |
1787 80.1%
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1786 79.9%
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1247 80.3%
|
4820 80.1%
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HER2 positive/equivocal |
418 18.7%
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427 19.1%
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288 18.6%
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1133 18.8%
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Breast disease subtype
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants |
ER+ or PR+, HER2- |
1437 64.4%
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1419 63.5%
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1015 65.4%
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3871 64.3%
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ER+ or PR+, HER2+ |
292 13.1%
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312 14.0%
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205 13.2%
|
809 13.4%
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ER/PR-, HER2- (triple neg) |
350 15.7%
|
367 16.4%
|
232 14.9%
|
949 15.8%
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ER/PR-, HER2+ (triple neg) |
126 5.6%
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115 5.1%
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83 5.3%
|
324 5.4%
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Stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants |
Stage I |
721 32.3%
|
770 34.5%
|
509 32.8%
|
2000 33.2%
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Stage II |
992 44.5%
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954 42.7%
|
694 44.7%
|
2640 43.9%
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Stage III |
472 21.2%
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460 20.6%
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304 19.6%
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1236 20.5%
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[1]
Measure Description: Staging criterial is per AJCC 6th Edition, 2002. Higher staging means worse disease.
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Chemotherapy
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants |
Not given or planned |
446 20.0%
|
454 20.3%
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319 20.6%
|
1219 20.3%
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Given or planned |
1779 79.7%
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1778 79.6%
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1232 79.4%
|
4789 79.6%
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Hormonal Therapy
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 2231 participants | 2235 participants | 1552 participants | 6018 participants |
Not given or planned |
542 24.3%
|
535 23.9%
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367 23.6%
|
1444 24.0%
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Given or planned |
1670 74.9%
|
1686 75.4%
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1170 75.4%
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4526 75.2%
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Name/Title: | SWOG statistician |
Organization: | SWOG Statistics & Data Management Center |
Phone: | 2066674263 |
EMail: | jmiao@fredhutch.org |
Responsible Party: | Southwest Oncology Group |
ClinicalTrials.gov Identifier: | NCT00127205 |
Other Study ID Numbers: |
CDR0000437061 S0307 ( Other Identifier: SWOG ) |
First Submitted: | August 3, 2005 |
First Posted: | August 5, 2005 |
Results First Submitted: | June 20, 2019 |
Results First Posted: | August 28, 2019 |
Last Update Posted: | August 28, 2020 |