Trial · NCT00127205

S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.

NCT00127205, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2019-08-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer. Trials, record NCT00127205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00127205

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
NCT number: NCT00127205
Status: Completed
Phases: Phase 3
Enrollment: 6,097 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Breast Cancer
Interventions: clodronate disodium, ibandronate sodium, zoledronic acid
First posted: 2005-08-05
Last updated: 2021-07-02
Results first posted: 2019-08-28

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-free Survival	Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence	Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.
Secondary	Overall Survival	follow up completed every 6 months for 5 years and then annually for 5 years or until death	Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 5 year overall survival rate.
Secondary	Distributions of Sites of First Recurrence on the Three Arms.	Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence	All sites of invasive disease documented within 30 days of first documentation of invasive recurrence.
Secondary	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.	Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival	Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence	Only eligible patients will be included in the analysis.	percentage of analyzed participants	NUMBER
SECONDARY	Overall Survival	follow up completed every 6 months for 5 years and then annually for 5 years or until death	Only eligible patients will be included in the analysis.	percentage of analyzable patients	NUMBER
SECONDARY	Distributions of Sites of First Recurrence on the Three Arms.	Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.	Patients who received at least one dose of protocol treatment.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group393

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Disease-free Survival	Arm I Zoledronate		88	95% Confidence Interval 87 to 90	percentage of analyzed participants
Disease-free Survival	Arm II Clodronate		88	95% Confidence Interval 86 to 89	percentage of analyzed participants
Disease-free Survival	Arm III Ibandronate		87	95% Confidence Interval 86 to 89	percentage of analyzed participants
Overall Survival	Arm I Zoledronate		93	95% Confidence Interval 91 to 94	percentage of analyzable patients
Overall Survival	Arm II Clodronate		92	95% Confidence Interval 91 to 94	percentage of analyzable patients
Overall Survival	Arm III Ibandronate		93	95% Confidence Interval 92 to 94	percentage of analyzable patients
Distributions of Sites of First Recurrence on the Three Arms.	Arm I Zoledronate	Local/Regional only	41		Participants
Distributions of Sites of First Recurrence on the Three Arms.	Arm II Clodronate	Local/Regional only	55		Participants
Distributions of Sites of First Recurrence on the Three Arms.	Arm III Ibandronate	Local/Regional only	36		Participants
Distributions of Sites of First Recurrence on the Three Arms.	Arm I Zoledronate	Contralateral only	17		Participants

1 to 10 of 393Source ClinicalTrials.gov

See all 393 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I Zoledronate	2,262
Overall Study	STARTED	Arm II Clodronate	2,268
Overall Study	STARTED	Arm III Ibandronate	1,567
Overall Study	COMPLETED	Arm I Zoledronate	1,433
Overall Study	COMPLETED	Arm II Clodronate	1,295
Overall Study	COMPLETED	Arm III Ibandronate	955
Overall Study	NOT COMPLETED	Arm I Zoledronate	829
Overall Study	NOT COMPLETED	Arm II Clodronate	973
Overall Study	NOT COMPLETED	Arm III Ibandronate	612

Source ClinicalTrials.gov

Adverse events690

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hemoglobin	Blood and lymphatic system disorders	Arm I Zoledronic Acid	376	2,125
other	Hemoglobin	Blood and lymphatic system disorders	Arm II Clodronate	326	2,186
other	Hemoglobin	Blood and lymphatic system disorders	Arm III Ibandronate	251	1,530
other	Constipation	Gastrointestinal disorders	Arm I Zoledronic Acid	230	2,125
other	Constipation	Gastrointestinal disorders	Arm II Clodronate	259	2,186
other	Constipation	Gastrointestinal disorders	Arm III Ibandronate	180	1,530
other	Diarrhea	Gastrointestinal disorders	Arm I Zoledronic Acid	288	2,125
other	Diarrhea	Gastrointestinal disorders	Arm II Clodronate	447	2,186
other	Diarrhea	Gastrointestinal disorders	Arm III Ibandronate	223	1,530
other	Heartburn/dyspepsia	Gastrointestinal disorders	Arm I Zoledronic Acid	138	2,125

1 to 10 of 690Source ClinicalTrials.gov

See all 690 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I Zoledronic Acid	238	2,231
Total, all-cause mortality	Arm II Clodronate	263	2,235
Total, all-cause mortality	Arm III Ibandronate	182	1,552
Total, other adverse events	Arm I Zoledronic Acid	1,854	2,125
Total, other adverse events	Arm II Clodronate	1,942	2,186
Total, other adverse events	Arm III Ibandronate	1,366	1,530
Total, serious adverse events	Arm I Zoledronic Acid	21	2,125
Total, serious adverse events	Arm II Clodronate	190	2,186
Total, serious adverse events	Arm III Ibandronate	141	1,530

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32929540	DERIVED	PubMed
38979716	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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