A Phase 3 interventional study of Radiation Therapy and Questionnaire Administration in Ductal Breast Carcinoma, Invasive Breast Carcinoma and Lobular Breast Carcinoma, sponsored by Alliance for Clinical Trials in Oncology. Active, not recruiting at 859 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care
Among 50 studies in Carcinoma, Ductal, Breast with a site in United States — 4 open to participants now, 9 under way, 2 of them phase 3. Carcinoma, Ductal, Breast · United States.
Among the 50 studies in Carcinoma, Ductal, Breast with a site in United States, this one is the 3rd largest by enrollment of the 42 interventional ones that give a count, is one of 2 that started in 2018, is one of 7 in phase 3, and was the 42nd registered.
86 studies on the registry are indexed under Carcinoma, Ductal, Breast; 7 are open to participants now.
Browse Carcinoma, Ductal, Breast studies →4 of the 50 studies in Carcinoma, Ductal, Breast with a site in United States are open now. Recruiting first, the newest first:
Natera, Inc. · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 45+ · Women only
Stanford University · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 7 Carcinoma, Ductal, Breast studies recruiting now, 5 (71%) set no upper age limit and 2 (29%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
50 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 16 · Phase 3 7
First in 1997; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 898 is above the median of 92 across 69 interventional studies indexed under Carcinoma, Ductal, Breast.
Median enrollment 48 across the 42 interventional studies, 74 across the 5 observational. Of the 37 that completed or were terminated, 11 (30%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 50 have an industry lead sponsor. The 10 most frequent:
Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Alliance for Clinical Trials in Oncology has 3 studies filed under Carcinoma, Ductal, Breast — fewer than ten, so there is no comparison to draw.
5 of the studies in Carcinoma, Ductal, Breast with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01953588Phase 3Alliance for Clinical Trials in OncologyFulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery | 2027-04-01 |
| NCT03909282Stanford UniversitySurgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma | 2026-12 |
| NCT00909909Rutgers, The State University of New JerseyRadiation Therapy in Treating Women With Early Stage Breast Cancer | 2027-07 |
| NCT05837767Memorial Sloan Kettering Cancer CenterA Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue | 2027-07-24 |
| NCT04084730Memorial Sloan Kettering Cancer CenterStudy of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer | 2027-08-30 |
Among the 50 studies in Carcinoma, Ductal, Breast with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.
PRIMARY OBJECTIVES:
I. To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.
II. To evaluate the local and local regional recurrence rate. III. To compare reconstruction complication rates based on reconstruction method (autologous +/- implant versus [vs] implant only) and timing of reconstruction received (immediate vs. intent for delayed).
TERTIARY OBJECTIVES:
I. To evaluate reconstructed breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation.
II. To evaluate reconstructed breast photographic cosmetic scores 24 months after radiation based on the method and timing of reconstruction received.
III. To estimate the incidence of arm lymphedema by treatment arm. IV. To compare physical well-being, psychosocial well-being, sexual well-being, satisfaction with breast/nipples/abdomen, and satisfaction with overall outcome between the treatment arms at 24 months after radiation.
V. To estimate patient satisfaction with trial participation by treatment arm as measured by the Was It Worth It Questionnaire at 24 months after radiation.
VI. To compare the direct and indirect patient costs for radiation therapy by treatment arm.
VII. To compare patient reported total health care service utilization 12 months after the completion of radiation.
VIII. To compare the economic impact of treatment. IX. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 and determine correlations with a higher likelihood of adverse radiation reactions (radiation sensitivity) and with toxicities.
X. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 to determine correlations with secondary endpoints such as local-regional control.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.
GROUP II: Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.
After completion of study, patients are followed up for 5 years.
Inclusion Criteria:
Patients will be staged according to the TNM staging system
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.
Radiation: Radiation Therapy · Other: Questionnaire Administration · Other: Quality-of-Life Assessment · Other: Laboratory Biomarker Analysis
Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.
Other: Questionnaire Administration · Other: Quality-of-Life Assessment · Other: Laboratory Biomarker Analysis · Radiation: Hypofractionated Radiation Therapy
Undergo RT
Ancillary studies
Ancillary studies
Correlative studies
Undergo hypofractionated RT
Proportion of Breast Reconstruction Complications
The primary endpoint of this trial is the rate of ipsilateral breast reconstruction complications defined (in the protocol in 10.0. Measurement of effect) as; Capsular contracture (Baker Grade III or IV only), Complete failure of the implant/skin flap, Unplanned admission for reconstruction related issue(s) including but not limited to infection, wound healing complication or pain, Unplanned return to the operating room for recon related issue including but not limited to infection, prosthesis exposure, failed reconstruction, implant removal, wound healing complications or contracture management. Note: Routine revisions such as dog-ear corrections, fat grafting, and contralateral breast revision will be recorded, but not counted towards the primary endpoint; ii) Complications related to the contralateral breast will be collected but will not count towards the assessment of the primary endpoint, ipsilateral breast complications will be counted towards the primary endpoint.
Time frame: 24 months
Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events 4.0 Toxicity
The proportion of patients with acute or late radiation complications, will be estimated separately by treatment arm and will be compared across the two arms using two-sample test of proportions (Z test) with a two-sided alternative.
Time frame: 5 years
Local and Local Regional Recurrence
The cumulative incidence of local and local regional recurrence will be estimated separately by treatment arm using the cumulative incidence function treating death as the competing risk and will be compared using Gray's test.
Time frame: 3 years
Local and Local Regional Recurrence-free Survival
Local and local regional recurrence free survival rate at three years will be summarized for each arm using the Kaplan-Meier estimators, and will be compared using a log rank test. Any recurrence or death will be considered an event.
Time frame: 3 years
Reconstruction Complication Rates Based on Reconstruction Method (Autologous +/- Implant Versus [vs.] Implant Only) and Timing of Reconstruction Received (Immediate vs. Intent for Delayed)
Between-arm differences in reconstruction complication rates will be assessed separately within each of the six subgroups based on type and timing of reconstruction. Between-arm differences in complication rates will also be assessed within the two broader subgroups of patients who receive implant only and those who receive autologous based reconstruction. Within each subgroup, the comparison will be done using a two-sample Z test of proportions with a two-sided alternative.
Time frame: Up to 5 years
Reconstructed Breast Photographic Cosmetic Scores
Two year photographic cosmetic scores will be summarized by treatment arm and will be compared across the treatment arms using a Wilcoxon rank-sum test with a two-sided alternative. The proportions of patients with poor global cosmetic score (defined as a cosmetic score of 3: poor or large difference) at 24 months after radiation will be summarized separately by treatment arm and will be compared using a two-sample test of proportions with a two-sided alternative.
Time frame: At 24 months
Reconstructed Breast Photographic Cosmetic Scores Based on the Method and Timing of Reconstruction Received
Two year photographic cosmetic scores and the proportions of patients with poor global cosmetic score will be assessed separately by timing and method of reconstruction subgroups using similar method described above.
Time frame: At 24 months
Incidence of Arm Lymphedema as Measured by Percent Change in Ipsilateral Arm Volume Post-radiation From Its Pre-radiation Volume
The proportions of patients with arm lymphedema (defined as a change of 10% or greater in ipsilateral arm volume from the pre-radiation therapy \[RT\] volume) at 2 year post radiation will be summarized and will be compared across the two treatment arms using a two-sample test of proportions (Z test) with a two-sided alternative. Change in ipsilateral arm volume at each of the following time-points: 6, 12, 24 and 60 months post-radiation (relative to pre-RT) will be compared using a two sample t-test with a two-sided alternative. The changes in arm volume at these time points will also be analyzed as a repeated measure using a linear mixed model with patient as the random effect.
Time frame: Up to 5 years
Physical Well-being, Psychosocial Well-being, Sexual Well-being, Satisfaction With Breast/Nipples/Abdomen, and Satisfaction With Overall Outcome
Change in Lymphedema and Breast Cancer Questionnaire and Breast Lymphedema scores at 24 months post-radiation (relative to pre-RT) and patient satisfaction scores as measured by the Breast Questionnaire overall outcome scale will be summarized and will be compared across the treatment arms using a two-sample t-test with a two-sided alternative. Linear mixed models will also be used to assess these scores longitudinally.
Time frame: At to 24 months
Patient Satisfaction With Trial Participation by Treatment Arm as Measured by the Was It Worth It Questionnaire
Was It Worth It questionnaire responses to each of the five questions at 24 months will be summarized and the will be compared across treatment arms using a chi-square tests with a two-sided alternative.
Time frame: At 24 months
Economic Analyses
Direct costs of medical care to each patient will be estimated using utilization information from the health care expense survey and the health care utilization survey, along with publicly available Medicare reimbursement rates. In particular, based on the reported number of outpatient visits to the radiation oncologist, medical oncologist, surgeon who performed mastectomy, plastic surgeon or physical therapist, and the number of visits to the emergency room, the number of hospital admissions, and the number of surgical procedures to breast reconstruction, Medicare reimbursement rates can be used to estimate what the direct cost to each patient would be if that patient were covered by Medicare. Generalized linear models will then be used to model these costs as a function of treatment, time on study, and all available baseline patient characteristics to assess the extent to which estimated direct cost is impacted by the type of radiation dosing.
Time frame: Up to 5 years
| Milestone | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) |
|---|---|---|
| Started | 449 | 449 |
| Completed | 403 | 422 |
| Not completed | 46 | 27 |
| Withdrew: Withdrawal by subject | 30 | 8 |
| Withdrew: Other complicating disease | 3 | 4 |
| Withdrew: Ineligible | 9 | 14 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Alternative therapy prior to beginning protocol therapy | 1 | 1 |
| Withdrew: Failed to begin protocol therapy due to other reasons | 2 | 0 |
The primary endpoint of this trial is the rate of ipsilateral breast reconstruction complications defined (in the protocol in 10.0. Measurement of effect) as; Capsular contracture (Baker Grade III or IV only), Complete failure of the implant/skin flap, Unplanned admission for reconstruction related issue(s) including but not limited to infection, wound healing complication or pain, Unplanned return to the operating room for recon related issue including but not limited to infection, prosthesis exposure, failed reconstruction, implant removal, wound healing complications or contracture management. Note: Routine revisions such as dog-ear corrections, fat grafting, and contralateral breast revision will be recorded, but not counted towards the primary endpoint; ii) Complications related to the contralateral breast will be collected but will not count towards the assessment of the primary endpoint, ipsilateral breast complications will be counted towards the primary endpoint.
| proportion of participants | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) |
|---|---|---|
| Proportion of Breast Reconstruction Complications | 0.102 | 0.123 |
The proportion of patients with acute or late radiation complications, will be estimated separately by treatment arm and will be compared across the two arms using two-sample test of proportions (Z test) with a two-sided alternative.
| proportion of participants | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) |
|---|---|---|
| Acute Radiation | 0.077 | .050 |
| Late Radiation | 0.060 | 0.063 |
The cumulative incidence of local and local regional recurrence will be estimated separately by treatment arm using the cumulative incidence function treating death as the competing risk and will be compared using Gray's test.
| percentage of patients with event | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) |
|---|---|---|
| Local and Local Regional Recurrence | 2.2 (0.2 to 2.3) | 0.7 (0.2 to 2.2) |
Local and local regional recurrence free survival rate at three years will be summarized for each arm using the Kaplan-Meier estimators, and will be compared using a log rank test. Any recurrence or death will be considered an event.
| percentage of patients without event | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) |
|---|---|---|
| Local and Local Regional Recurrence-free Survival | 96.2 (94.3 to 98.2) | 97.0 (95.4 to 98.7) |
Between-arm differences in reconstruction complication rates will be assessed separately within each of the six subgroups based on type and timing of reconstruction. Between-arm differences in complication rates will also be assessed within the two broader subgroups of patients who receive implant only and those who receive autologous based reconstruction. Within each subgroup, the comparison will be done using a two-sample Z test of proportions with a two-sided alternative.
Results for this outcome have not been posted.
Two year photographic cosmetic scores will be summarized by treatment arm and will be compared across the treatment arms using a Wilcoxon rank-sum test with a two-sided alternative. The proportions of patients with poor global cosmetic score (defined as a cosmetic score of 3: poor or large difference) at 24 months after radiation will be summarized separately by treatment arm and will be compared using a two-sample test of proportions with a two-sided alternative.
Results for this outcome have not been posted.
Two year photographic cosmetic scores and the proportions of patients with poor global cosmetic score will be assessed separately by timing and method of reconstruction subgroups using similar method described above.
Results for this outcome have not been posted.
The proportions of patients with arm lymphedema (defined as a change of 10% or greater in ipsilateral arm volume from the pre-radiation therapy \[RT\] volume) at 2 year post radiation will be summarized and will be compared across the two treatment arms using a two-sample test of proportions (Z test) with a two-sided alternative. Change in ipsilateral arm volume at each of the following time-points: 6, 12, 24 and 60 months post-radiation (relative to pre-RT) will be compared using a two sample t-test with a two-sided alternative. The changes in arm volume at these time points will also be analyzed as a repeated measure using a linear mixed model with patient as the random effect.
Results for this outcome have not been posted.
Change in Lymphedema and Breast Cancer Questionnaire and Breast Lymphedema scores at 24 months post-radiation (relative to pre-RT) and patient satisfaction scores as measured by the Breast Questionnaire overall outcome scale will be summarized and will be compared across the treatment arms using a two-sample t-test with a two-sided alternative. Linear mixed models will also be used to assess these scores longitudinally.
Results for this outcome have not been posted.
Was It Worth It questionnaire responses to each of the five questions at 24 months will be summarized and the will be compared across treatment arms using a chi-square tests with a two-sided alternative.
Results for this outcome have not been posted.
Direct costs of medical care to each patient will be estimated using utilization information from the health care expense survey and the health care utilization survey, along with publicly available Medicare reimbursement rates. In particular, based on the reported number of outpatient visits to the radiation oncologist, medical oncologist, surgeon who performed mastectomy, plastic surgeon or physical therapist, and the number of visits to the emergency room, the number of hospital admissions, and the number of surgical procedures to breast reconstruction, Medicare reimbursement rates can be used to estimate what the direct cost to each patient would be if that patient were covered by Medicare. Generalized linear models will then be used to model these costs as a function of treatment, time on study, and all available baseline patient characteristics to assess the extent to which estimated direct cost is impacted by the type of radiation dosing.
Results for this outcome have not been posted.
Collected over Adverse events were followed for 73 months and mortality was followed for 80 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group I (Radiation Therapy) | 15/431 (3.5%) | 48/431 (11.1%) | 405/431 (94%) |
| Group II (Hypofractionated Radiation Therapy) | 10/443 (2.3%) | 58/443 (13.1%) | 424/443 (95.7%) |
| Event | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) |
|---|---|---|
| Breast infectionInfections and infestations | 8/431 | 4/443 |
| FatigueGeneral disorders and administration site conditions | 7/431 | 3/443 |
| Skin infectionInfections and infestations | 1/431 | 7/443 |
| Joint range of motion decreasedMusculoskeletal and connective tissue disorders | 2/431 | 7/443 |
| Peripheral sensory neuropathyNervous system disorders | 6/431 | 1/443 |
| Wound dehiscenceInjury, poisoning and procedural complications | 3/431 | 6/443 |
| Dermatitis radiationInjury, poisoning and procedural complications | 5/431 | 5/443 |
| Chest wall painMusculoskeletal and connective tissue disorders | 5/431 | 5/443 |
| Wound infectionInfections and infestations | 3/431 | 5/443 |
| Wound complicationInjury, poisoning and procedural complications | 2/431 | 5/443 |
| Event | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) |
|---|---|---|
| Dermatitis radiationInjury, poisoning and procedural complications | 379/431 | 369/443 |
| FatigueGeneral disorders and administration site conditions | 319/431 | 346/443 |
| Joint range of motion decreasedMusculoskeletal and connective tissue disorders | 182/431 | 197/443 |
| Chest wall painMusculoskeletal and connective tissue disorders | 181/431 | 196/443 |
| Peripheral sensory neuropathyNervous system disorders | 133/431 | 150/443 |
| LymphedemaVascular disorders | 133/431 | 131/443 |
| Superficial soft tissue fibrosisMusculoskeletal and connective tissue disorders | 104/431 | 129/443 |
| Skin hyperpigmentationSkin and subcutaneous tissue disorders | 84/431 | 114/443 |
| Fibrosis deep connective tissueMusculoskeletal and connective tissue disorders | 71/431 | 83/443 |
| TelangiectasiaSkin and subcutaneous tissue disorders | 46/431 | 61/443 |
All enrolled patients
| Age, Continuous(years) | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) | Total |
|---|---|---|---|
| Mean | 49.5 ± 10.56 | 49.4 ± 10.70 | 49.4 ± 10.63 |
| Sex: Female, Male(Participants) | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) | Total |
|---|---|---|---|
| Female | 449 | 449 | 898 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) | Total |
|---|---|---|---|
| Hispanic or Latino | 32 | 37 | 69 |
| Not Hispanic or Latino | 383 | 392 | 775 |
| Unknown or Not Reported | 34 | 20 | 54 |
| Race (NIH/OMB)(Participants) | Group I (Radiation Therapy) | Group II (Hypofractionated Radiation Therapy) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 18 | 19 | 37 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 41 | 44 | 85 |
| White | 357 | 349 | 706 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 31 | 32 | 63 |
Showing the first 100 of 859 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Feb 2024, 70 months.
Results were first posted in Feb 2026, 2 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology →