Trial · NCT01349322
Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
NCT01349322, Phase 3, Active not recruiting, Radiation Therapy Oncology Group; results first posted 2023-04-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery. Trials, record NCT01349322. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01349322
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
- NCT number
- NCT01349322
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 2,354 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Breast Cancer
- Interventions
- Standard fractionation whole breast irradiation, Hypofractionated whole breast irradiation, Concurrent boost, Sequential boost
- First posted
- 2011-05-06
- Last updated
- 2026-03-05
- Results first posted
- 2023-04-06
- Limitations and caveats
Due to a lower than anticipated incidence of in-breast recurrence (IBR), the protocol was amended to allow for timely reporting of the trial results with at least 46 IBR events, while maintaining statistical integrity and reflecting current knowledge of the observed IBR incidence in the control arm.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With In-breast Recurrence (Local Failure) | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are reported here. | In-breast recurrence (IBR) is defined as any of the following: invasive local recurrence-ipsilateral breast (within treatment field); invasive local recurrence-ipsilateral breast (outside treatment field); non-invasive local recurrence-ipsilateral breast (within treatment field); or non-invasive local recurrence-ipsilateral breast (outside treatment field). Time to IBR is defined as time from randomization to the date of first IBR, last known follow-up (censored), or death without IBR (competing risk). IBR rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. 5-year rates are provided. |
| Secondary | Percentage of Participants Alive | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here. | Failure is defined as death due to any cause. Failure time (overall survival time) is defined as the time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method and distributions between the two arms are compared using the log-rank test. Five-year rates are provided here. |
| Secondary | Percentage of Participants Alive Without Disease | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here. | Disease-free survival (DFS) time is defined as time from randomization to local-regional disease recurrence, distant metastases, second/new primary, death due to any cause or last known follow-up (censored). DFS rates are estimated by the Kaplan-Meier method and distributions between the two arms are compared using the log-rank test. Five-year rates are provided here. |
| Secondary | Percentage of Participants Alive Without Distant Disease | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here. | Distant disease-free survival (DDFS) time is defined as time from randomization to distant metastases, second/new primary, death due to any cause or last known follow-up (censored). DDFS rates are estimated by the Kaplan-Meier method and distributions between the two arms are compared using the log-rank test. Five-year rates are provided here. |
| Secondary | Number of Participants by Highest Grade Adverse Event Reported as Definitely, Probably, or Possibly Related to Protocol Treatment | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data |
| Secondary | Change in Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis Subscale Score From Baseline to 3 Years | Baseline and 3 years | The BCTOS cosmesis subscale score measures perceived aesthetic (e.g., breast shape) status . Patients rated each item using a four-point scale evaluating the differences between the treated and the untreated breast (1=no difference, 2=slight difference, 3=moderate difference, 4=large difference) with higher scores indicating a worse outcome. The score for each subscale is the mean of the ratings over all items belonging to that specific subscale. Change was calculated as the value at 3 years minus the value at baseline. A positive change reflects a decline at 3 years and a negative change reflects an improvement at 3 years. |
| Secondary | Percentage of Participants With a Physician-reported Cosmetic Score of Excellent or Good at 3 Years | 3 years | Physicians rated cosmesis using a four point scale: * Excellent: When compared to the untreated breast or the original appearance of the breast, there is minimal/no difference in the size or shape of the treated breast. * Good: There is a slight difference in the size or shape of the treated breast as compared to the opposite breast or the original appearance of the treated breast. * Fair: Obvious differences in the size and shape of the treated breast. This change involves quarter or less of the breast. * Poor: Marked change in the appearance of the treated breast involving more than a quarter of the breast tissue. |
| Secondary | Correlation Between Dose-volume Data and Both Adverse Events and Efficacy | From randomization to end of follow-up. | |
| Secondary | Translational Research of Single Nucleotide Polymorphisms (SNPs) in Transforming Growth Factor Beta 1 (TGFB1) and Ataxia-Telangiesctasia Mutated (ATM) Genes | From randomization to last follow-up. | |
| Secondary | Treatment Cost | From randomization to end of treatment. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With In-breast Recurrence (Local Failure) | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are reported here. | Eligible population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here. | Eligible population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive Without Disease | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here. | Eligible population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive Without Distant Disease | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. Five-year rates are provided here. | Eligible population | percentage of participants | NUMBER |
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported as Definitely, Probably, or Possibly Related to Protocol Treatment | From randomization to last follow-up. Evaluated weekly during radiation therapy (RT), last day of RT, 1, 6, and 12 months after RT completion, then annually. Maximum follow-up at time of analysis was 10.1 years. | Adverse event population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis Subscale Score From Baseline to 3 Years | Baseline and 3 years | Quality of life population, with data at baseline and 3 years. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Physician-reported Cosmetic Score of Excellent or Good at 3 Years | 3 years | Quality of life population, with data at 3 years. | percentage of participants | NUMBER |
| SECONDARY | Correlation Between Dose-volume Data and Both Adverse Events and Efficacy | From randomization to end of follow-up. | |||
| SECONDARY | Translational Research of Single Nucleotide Polymorphisms (SNPs) in Transforming Growth Factor Beta 1 (TGFB1) and Ataxia-Telangiesctasia Mutated (ATM) Genes | From randomization to last follow-up. | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified analysis, therefore no assays were performed, and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial. | ||
| SECONDARY | Treatment Cost | From randomization to end of treatment. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With In-breast Recurrence (Local Failure) | Whole Breast Irradiation + Sequential Boost (Arm 1) | 2.0 | 95% Confidence Interval 1.4 to 2.9 | percentage of participants | |
| Percentage of Participants With In-breast Recurrence (Local Failure) | Hypofractionated Whole Breast Irradiation + Concurrent Boost (Arm 2) | 1.9 | 95% Confidence Interval 1.3 to 2.7 | percentage of participants | |
| Percentage of Participants Alive | Whole Breast Irradiation + Sequential Boost | 95.7 | 95% Confidence Interval 94.4 to 96.9 | percentage of participants | |
| Percentage of Participants Alive | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 95.1 | 95% Confidence Interval 93.8 to 96.4 | percentage of participants | |
| Percentage of Participants Alive Without Disease | Whole Breast Irradiation + Sequential Boost | 90.2 | 95% Confidence Interval 88.5 to 92.0 | percentage of participants | |
| Percentage of Participants Alive Without Disease | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 88.5 | 95% Confidence Interval 86.7 to 90.4 | percentage of participants | |
| Percentage of Participants Alive Without Distant Disease | Whole Breast Irradiation + Sequential Boost | 91.5 | 95% Confidence Interval 89.9 to 93.2 | percentage of participants | |
| Percentage of Participants Alive Without Distant Disease | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 90.2 | 95% Confidence Interval 88.4 to 91.9 | percentage of participants | |
| Number of Participants by Highest Grade Adverse Event Reported as Definitely, Probably, or Possibly Related to Protocol Treatment | Whole Breast Irradiation + Sequential Boost | Grade 1 | 427 | Participants | |
| Number of Participants by Highest Grade Adverse Event Reported as Definitely, Probably, or Possibly Related to Protocol Treatment | Hypofractionated Whole Breast Irradiation + Concurrent Boost | Grade 1 | 554 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Whole Breast Irradiation + Sequential Boost | 1,169 | |
| Overall Study | STARTED | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 1,185 | |
| Overall Study | Eligible population | Whole Breast Irradiation + Sequential Boost | 1,124 | |
| Overall Study | Eligible population | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 1,138 | |
| Overall Study | Adverse event population | Whole Breast Irradiation + Sequential Boost | 1,100 | |
| Overall Study | Adverse event population | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 1,123 | |
| Overall Study | Quality of Life Population | Whole Breast Irradiation + Sequential Boost | 429 | |
| Overall Study | Quality of Life Population | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 449 | |
| Overall Study | COMPLETED | Whole Breast Irradiation + Sequential Boost | 1,124 | |
| Overall Study | COMPLETED | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 1,138 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events136
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 | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Whole Breast Irradiation + Sequential Boost | 60 | 1,100 | |
| other | Nausea | Gastrointestinal disorders | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 56 | 1,123 | |
| other | Fatigue | General disorders and administration site conditions | Whole Breast Irradiation + Sequential Boost | 435 | 1,100 | |
| other | Fatigue | General disorders and administration site conditions | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 427 | 1,123 | |
| other | Localized edema | General disorders and administration site conditions | Whole Breast Irradiation + Sequential Boost | 123 | 1,100 | |
| other | Localized edema | General disorders and administration site conditions | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 116 | 1,123 | |
| other | Pain | General disorders and administration site conditions | Whole Breast Irradiation + Sequential Boost | 160 | 1,100 | |
| other | Pain | General disorders and administration site conditions | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 144 | 1,123 | |
| other | Dermatitis radiation | Injury, poisoning and procedural complications | Whole Breast Irradiation + Sequential Boost | 399 | 1,100 | |
| other | Dermatitis radiation | Injury, poisoning and procedural complications | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 384 | 1,123 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Whole Breast Irradiation + Sequential Boost | 87 | 1,124 |
| Total, all-cause mortality | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 86 | 1,138 |
| Total, other adverse events | Whole Breast Irradiation + Sequential Boost | 866 | 1,100 |
| Total, other adverse events | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 910 | 1,123 |
| Total, serious adverse events | Whole Breast Irradiation + Sequential Boost | 18 | 1,100 |
| Total, serious adverse events | Hypofractionated Whole Breast Irradiation + Concurrent Boost | 20 | 1,123 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42114027 | DERIVED |
Source 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Whole Breast Irradiation + Sequential Boost vs Hypofractionated Whole Breast Irradiation + Concurrent Boost: deaths from any cause | Trial comparisons |
| Whole Breast Irradiation + Sequential Boost vs Hypofractionated Whole Breast Irradiation + Concurrent Boost: serious adverse events | Trial comparisons |
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01349322
GET https://conductscience.org/api/trials/v1/NCT01349322/results?page=2