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Radiation Therapy in Treating Patients With Recurrent Breast Cancer
NA trial testing intracavitary balloon brachytherapy in Breast Cancer in 13 participants. Completed in 6 July 2018.
| Lead sponsor | Case Comprehensive Cancer Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 23 September 2008 |
| Primary completion | 6 July 2018 |
| Estimated completion | 6 July 2018 |
| Sites | 3 locations across United States |
Case Comprehensive Cancer Center — full company profile →
18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 0 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 0 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 0 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 0 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 0 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 9 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 9 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 10 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 11 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 0 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 0 | |
| Intracavitary Balloon Brachytherapy | 0 |
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
| Group | Value | 95% CI |
|---|---|---|
| Intraoperative Radiation Therapy | 0 | |
| Intracavitary Balloon Brachytherapy | 0 |
Time frame: up to 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intraoperative Radiation T… | Intracavitary Balloon Brac… |
|---|---|---|---|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | — | — |
| Induration/fibrosis (skin and subcutaneous tissue) | Skin and subcutaneous tissue disorders | — | — |
| Seroma | Musculoskeletal and connective tissue disorders | — | — |
| Pain - Joint | Musculoskeletal and connective tissue disorders | — | — |
| Hypertension | Cardiac disorders | — | — |
| Fatigue | General disorders | — | — |
| Insomnia | General disorders | — | — |
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | Skin and subcutaneous tissue disorders | — | — |
| Hot flashes/flushes | Endocrine disorders | — | — |
| Edema: trunk/genital | Blood and lymphatic system disorders | — | — |
| Pain - Back | Musculoskeletal and connective tissue disorders | — | — |
| Pain - Head/headache | Musculoskeletal and connective tissue disorders | — | — |
| Breast indentation/dimpling | Skin and subcutaneous tissue disorders | — | — |
| Nail changes | Skin and subcutaneous tissue disorders | — | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — | — |
| Rash: dermatitis associated with radiation - Radiation | Skin and subcutaneous tissue disorders | — | — |
| Telangiectasia | Skin and subcutaneous tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Mood alteration - Depression | Nervous system disorders | — | — |
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | — | — |
| Pain - Pelvis | Musculoskeletal and connective tissue disorders | — | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — | — |
| Hemoglobin | Blood and lymphatic system disorders | — | — |
| Hemorrhage, pulmonary/upper respiratory - nose | Blood and lymphatic system disorders | — | — |
| Rigors/chills | General disorders | — | — |
| Burn | Skin and subcutaneous tissue disorders | — | — |
| Skin retraction | Skin and subcutaneous tissue disorders | — | — |
| Skin dimpling | Skin and subcutaneous tissue disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Heartburn/dyspepsia | Gastrointestinal disorders | — | — |
| Breast Infection | Infections and infestations | — | — |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) | Infections and infestations | — | — |
| Edema: limb | Blood and lymphatic system disorders | — | — |
| Lymphatics: seroma | Blood and lymphatic system disorders | — | — |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | — | — |
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | — | — |
| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | — | — |
| Fibrosis-cosmesis | Musculoskeletal and connective tissue disorders | — | — |
Data from ClinicalTrials.gov NCT00945061 adverse events section.
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer. PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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