Breast Neoplasms
Conditions
Brief summary
This phase I/II clinical trial studies the side effects of delivering radiation therapy in a single session instead of multiple treatments over several weeks and to see how well it works in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a type of radiation therapy focused only to the part of the breast that has cancer in it, given at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient partial-breast irradiation may cause fewer side effects, help prevent breast cancer from coming back, and improve the appearance of the breast and quality of life of patients with breast cancer.
Detailed description
This is a phase I/II study which will evaluate the complication rates, local control, cosmetic results, and quality of life of single fraction high gradient partial breast irradiation (HG-PBI) when used as the sole method of radiation therapy for patients with pathologic stage 0 (=\< 2 cm) or I carcinoma of the breast treated with partial mastectomy with histologically assessed negative surgical margins.
Interventions
RADIATIONaccelerated partial breast irradiation
Undergo HG-PBI
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node. * Negative histologic margins of partial mastectomy or re-excision specimen. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge. * Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm). * Systemic therapy, if planned, must be adjuvant in nature and not be scheduled to begin for at least 4 weeks after completion of HG-PBI. * Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation. * Postmenopausal status. * Age ≥ 50 years at diagnosis. * Able to understand and willing to sign IRB-approved written informed consent document. * English speaker.
Exclusion criteria
* Presence of distant metastases. * In situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma. * Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. * Premenopausal status. * Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor. * Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy. * Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis. * Diagnosis of a coexisting medical condition which limits life expectancy to \< 2 years. * Diagnosis of psychiatric or addictive disorders that would preclude obtaining informed consent. * History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. * Paget's disease of the nipple. * Skin involvement, regardless of tumor size. * Unsatisfactory breast for HG-PBI as determined by the treating physician. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, treatment with HG-PBI is technically problematic. * Partial mastectomy so extensive that the cosmetic result is fair or poor prior to HG-PBI as determined by the treating physician. * Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation. * Time between final definitive breast procedure to HG-PBI simulation is greater than 8 weeks. Inclusion of Women and Minorities -Women and members of all races and ethnic groups are eligible for this trial. Because breast cancer occurs rarely in men, men will not be recruited for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Are Free of Serious Treatment Related Toxicity | Up to 5 years | Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per CTCAE, v.4.0) or any other grade 4 or 5 toxicity attributed to the therapy. Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis and pericarditis. Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up. |
| Percentage of Patients Who Are Free of Breast Cancer in the Treated Breast | At 5 years | Percentage of patients without ipsilateral breast tumor recurrences (IBTR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5 | The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. For the global health and five functional scales (Cognitive Functioning, Emotional Functioning, Physical Functioning, Role Functioning, and Social Functioning) a high score correlates to a high level of functioning or a better outcome. For the three symptom scales and six single item scales (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Constipation, Diarrhea, Financial Difficulties) a high score correlates to high levels of symptoms or problems and a worse outcome. |
| Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5 | The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. For the four symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms, Breast Symptoms) a high score correlates to high levels of symptoms or problems and a worse outcome. For the four functional scales (Body Image, Future Perspective, Sexual Functioning, Sexual Enjoyment) a high score correlates to a high/healthy level of functioning or a better outcome |
| Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5 | The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor (0) and severe pain at (10) with the patient's mark providing a range of scores from 0-100 millimeters. A higher score indicates greater pain intensity. |
| Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5 | This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features. |
| Percentage of Patients Who Are Free of Breast Cancer in the Regional Lymph Nodes | At 5 years | Ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups. |
| Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5 | Using this scale, cosmesis is qualitatively evaluated by the treating radiation oncologist by comparing the treated breast with the contralateral breast using the Aronson Modified Scale. The global cosmetic result, appearance of the surgical scar, breast size, breast shape, skin color, location of the areola and nipple, and shape of the areola and nipple were scored on a 4-point scale. In this case 1 is 'excellent' with 4 being 'poor.' |
| Number of Patients With Complications Using CTCAE v. 4.0 | Up to 5 years | Acute complications are defined as complications that occurred from start of treatment until day 90. Late complications are defined as complications that occurred from Day 91 until completion of 5 year follow-up. |
| Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0 | Up to 5 years | Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up. |
| Percentage of Patients Undergoing Mastectomy on the Treated Side | At 5 years | — |
| Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5 | This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features. This is calculated from dividing the BRA score by the reference length from sternal notch to contralateral nipple and then multiplying that value by 100 to get a percentage. |
| Percentage of Patients Who Are Free From Distant Metastases | At 5 years | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment (HG-PBI) Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Treatment (HG-PBI) |
|---|---|
| Age, Continuous | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 4 / 50 |
| other Total, other adverse events | 32 / 50 | 48 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Percentage of Patients Who Are Free of Breast Cancer in the Treated Breast
Percentage of patients without ipsilateral breast tumor recurrences (IBTR).
Time frame: At 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (HG-PBI) | Percentage of Patients Who Are Free of Breast Cancer in the Treated Breast | 48 Participants |
Primary
Percentage of Patients Who Are Free of Serious Treatment Related Toxicity
Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per CTCAE, v.4.0) or any other grade 4 or 5 toxicity attributed to the therapy. Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis and pericarditis. Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up.
Time frame: Up to 5 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (HG-PBI) | Percentage of Patients Who Are Free of Serious Treatment Related Toxicity | Number of patients free of acute grade 3 or higher treatment related toxicity | 50 Participants |
| Treatment (HG-PBI) | Percentage of Patients Who Are Free of Serious Treatment Related Toxicity | Number of patients free of late grade 3 or higher treatment related toxicity | 49 Participants |
Secondary
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. For the global health and five functional scales (Cognitive Functioning, Emotional Functioning, Physical Functioning, Role Functioning, and Social Functioning) a high score correlates to a high level of functioning or a better outcome. For the three symptom scales and six single item scales (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Constipation, Diarrhea, Financial Difficulties) a high score correlates to high levels of symptoms or problems and a worse outcome.
Time frame: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Population: If participants did not complete the questionnaire or did not complete a question then they are not included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Emotional Functioning | 1.07 score on a scale | Standard Deviation 14.82 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Nausea and Vomiting | 2.71 score on a scale | Standard Deviation 10.87 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Social Functioning | -1.14 score on a scale | Standard Deviation 19.49 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Pain | -3.03 score on a scale | Standard Deviation 18.42 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Dyspnea | -1.55 score on a scale | Standard Deviation 19.18 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Cognitive Functioning | -2.27 score on a scale | Standard Deviation 17.46 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Global Health Status | -0.57 score on a scale | Standard Deviation 10.54 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Financial Difficulties | 0.81 score on a scale | Standard Deviation 26.34 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Fatigue | 5.68 score on a scale | Standard Deviation 19.23 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Role Functioning | 0 score on a scale | Standard Deviation 23.85 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Constipation | 0 score on a scale | Standard Deviation 20.33 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Insomnia | -2.33 score on a scale | Standard Deviation 23.45 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Physical Functioning | 0.67 score on a scale | Standard Deviation 6.53 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Diarrhea | 0.76 score on a scale | Standard Deviation 11.34 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Appetite Loss | -0.78 score on a scale | Standard Deviation 15.41 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Financial Difficulties | -0.72 score on a scale | Standard Deviation 21.65 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Appetite Loss | 0.68 score on a scale | Standard Deviation 14.42 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Role Functioning | 0.68 score on a scale | Standard Deviation 14.42 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Social Functioning | 2.38 score on a scale | Standard Deviation 11.28 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Pain | 0 score on a scale | Standard Deviation 22.31 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Physical Functioning | -0.11 score on a scale | Standard Deviation 11.19 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Constipation | 0 score on a scale | Standard Deviation 13.61 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Dyspnea | 1.36 score on a scale | Standard Deviation 16.61 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Global Health Status | -0.68 score on a scale | Standard Deviation 8.81 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Nausea and Vomiting | 1.7 score on a scale | Standard Deviation 7.01 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Cognitive Functioning | -6.12 score on a scale | Standard Deviation 18.22 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Diarrhea | 0 score on a scale | Standard Deviation 15.21 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Fatigue | 7.26 score on a scale | Standard Deviation 13.38 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Insomnia | 3.47 score on a scale | Standard Deviation 25.02 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Emotional Functioning | 0.34 score on a scale | Standard Deviation 15.31 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Global Health Status | -2.89 score on a scale | Standard Deviation 12.68 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Financial Difficulties | -2.9 score on a scale | Standard Deviation 19.66 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Cognitive Functioning | -6.46 score on a scale | Standard Deviation 16.95 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Appetite Loss | 0.69 score on a scale | Standard Deviation 12.84 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Role Functioning | 0.34 score on a scale | Standard Deviation 12.02 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Constipation | 0.68 score on a scale | Standard Deviation 14.42 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Physical Functioning | -1.58 score on a scale | Standard Deviation 14.25 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Diarrhea | 0.68 score on a scale | Standard Deviation 15.94 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Pain | -2.04 score on a scale | Standard Deviation 20.59 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Dyspnea | 1.36 score on a scale | Standard Deviation 13.54 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Nausea and Vomiting | 1.36 score on a scale | Standard Deviation 6.66 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Emotional Functioning | 1.93 score on a scale | Standard Deviation 15.3 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Social Functioning | 2.38 score on a scale | Standard Deviation 12.27 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Insomnia | 2.72 score on a scale | Standard Deviation 33.22 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Fatigue | 3.51 score on a scale | Standard Deviation 15.16 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Diarrhea | -0.71 score on a scale | Standard Deviation 8.48 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Physical Functioning | -2.6 score on a scale | Standard Deviation 11.59 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Global Health Status | -2.48 score on a scale | Standard Deviation 12.76 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Emotional Functioning | 2.3 score on a scale | Standard Deviation 15.22 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Fatigue | 3.78 score on a scale | Standard Deviation 15.59 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Insomnia | 2.17 score on a scale | Standard Deviation 28.46 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Financial Difficulties | -6.06 score on a scale | Standard Deviation 21.89 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Appetite Loss | -1.42 score on a scale | Standard Deviation 9.72 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Constipation | 1.42 score on a scale | Standard Deviation 16.96 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Role Functioning | -0.35 score on a scale | Standard Deviation 16.11 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Social Functioning | 2.48 score on a scale | Standard Deviation 14.74 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Nausea and Vomiting | 2.48 score on a scale | Standard Deviation 10.41 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Cognitive Functioning | -3.9 score on a scale | Standard Deviation 16.74 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Dyspnea | 5.67 score on a scale | Standard Deviation 16.03 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Pain | -3.26 score on a scale | Standard Deviation 13.89 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Financial Difficulties | -4.17 score on a scale | Standard Deviation 18.78 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Appetite Loss | 1.52 score on a scale | Standard Deviation 14.3 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Cognitive Functioning | -5.43 score on a scale | Standard Deviation 16.15 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Constipation | 5.43 score on a scale | Standard Deviation 26.16 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Diarrhea | 0 score on a scale | Standard Deviation 12.75 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Dyspnea | 5.3 score on a scale | Standard Deviation 18.94 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Emotional Functioning | 4.52 score on a scale | Standard Deviation 10.2 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Fatigue | 1.64 score on a scale | Standard Deviation 14.99 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Global Health Status | -4.26 score on a scale | Standard Deviation 17.29 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Insomnia | -1.52 score on a scale | Standard Deviation 28.71 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Nausea and Vomiting | 3.79 score on a scale | Standard Deviation 16.42 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Pain | -1.14 score on a scale | Standard Deviation 18.47 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Physical Functioning | -0.66 score on a scale | Standard Deviation 9.84 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Role Functioning | 1.14 score on a scale | Standard Deviation 14.56 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Social Functioning | 4.26 score on a scale | Standard Deviation 13.16 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Pain | -1.39 score on a scale | Standard Deviation 17.13 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Social Functioning | 1.74 score on a scale | Standard Deviation 15.47 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Financial Difficulties | -1.48 score on a scale | Standard Deviation 22.42 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Dyspnea | 8.33 score on a scale | Standard Deviation 23.32 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Diarrhea | 1.39 score on a scale | Standard Deviation 13.68 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Nausea and Vomiting | 1.74 score on a scale | Standard Deviation 7.87 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Role Functioning | 1.74 score on a scale | Standard Deviation 12.51 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Cognitive Functioning | -5.9 score on a scale | Standard Deviation 13.96 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Global Health Status | -1.39 score on a scale | Standard Deviation 15.21 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Emotional Functioning | 1.56 score on a scale | Standard Deviation 16.09 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Appetite Loss | 2.08 score on a scale | Standard Deviation 15.99 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Insomnia | 5.67 score on a scale | Standard Deviation 28.93 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Fatigue | 1.62 score on a scale | Standard Deviation 16.04 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Physical Functioning | -1.99 score on a scale | Standard Deviation 12.58 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Constipation | 1.39 score on a scale | Standard Deviation 21.7 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Fatigue | 0.4 score on a scale | Standard Deviation 14.12 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Appetite Loss | -0.81 score on a scale | Standard Deviation 11.76 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Global Health Status | -3.57 score on a scale | Standard Deviation 14.51 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Emotional Functioning | 0.79 score on a scale | Standard Deviation 15.49 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Insomnia | 3.25 score on a scale | Standard Deviation 29.63 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Dyspnea | 3.25 score on a scale | Standard Deviation 10.01 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Nausea and Vomiting | 0 score on a scale | Standard Deviation 3.73 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Diarrhea | 2.38 score on a scale | Standard Deviation 15.43 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Pain | -1.59 score on a scale | Standard Deviation 23.52 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Constipation | -0.79 score on a scale | Standard Deviation 11.61 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Social Functioning | 1.98 score on a scale | Standard Deviation 14.82 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Physical Functioning | -1.63 score on a scale | Standard Deviation 11.41 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Cognitive Functioning | -1.59 score on a scale | Standard Deviation 13.17 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Role Functioning | -0.4 score on a scale | Standard Deviation 16.66 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Financial Difficulties | -6.84 score on a scale | Standard Deviation 19.01 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Emotional Functioning | 3.43 score on a scale | Standard Deviation 11.07 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Social Functioning | 3.43 score on a scale | Standard Deviation 14.67 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Insomnia | 5.71 score on a scale | Standard Deviation 24.9 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Fatigue | 2.86 score on a scale | Standard Deviation 16.47 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Role Functioning | 0 score on a scale | Standard Deviation 23.22 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Constipation | 0.98 score on a scale | Standard Deviation 12.94 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Physical Functioning | -1.21 score on a scale | Standard Deviation 10.62 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Nausea and Vomiting | 1.43 score on a scale | Standard Deviation 7.42 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Global Health Status | -3.92 score on a scale | Standard Deviation 17.44 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Pain | -3.81 score on a scale | Standard Deviation 24.62 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Diarrhea | 2.02 score on a scale | Standard Deviation 16.54 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Appetite Loss | -1.9 score on a scale | Standard Deviation 7.85 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Cognitive Functioning | -4.41 score on a scale | Standard Deviation 12.52 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Dyspnea | 3.81 score on a scale | Standard Deviation 15.7 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Financial Difficulties | -5.21 score on a scale | Standard Deviation 17.16 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Dyspnea | 5.05 score on a scale | Standard Deviation 18.86 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Pain | -0.51 score on a scale | Standard Deviation 23.01 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Constipation | 0 score on a scale | Standard Deviation 20.74 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Insomnia | 3.03 score on a scale | Standard Deviation 24.1 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Financial Difficulties | -4.6 score on a scale | Standard Deviation 14.7 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Physical Functioning | -2.79 score on a scale | Standard Deviation 8.18 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Cognitive Functioning | 0.52 score on a scale | Standard Deviation 13.04 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Fatigue | 5.05 score on a scale | Standard Deviation 16.45 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Emotional Functioning | 4.25 score on a scale | Standard Deviation 10.27 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Role Functioning | -5.56 score on a scale | Standard Deviation 20.27 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Appetite Loss | 2.02 score on a scale | Standard Deviation 8.08 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Nausea and Vomiting | 0 score on a scale | Standard Deviation 4.17 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Diarrhea | 1.04 score on a scale | Standard Deviation 15.8 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Social Functioning | 4.69 score on a scale | Standard Deviation 15.4 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30 | Global Health Status | -1.3 score on a scale | Standard Deviation 11.99 |
Secondary
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. For the four symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms, Breast Symptoms) a high score correlates to high levels of symptoms or problems and a worse outcome. For the four functional scales (Body Image, Future Perspective, Sexual Functioning, Sexual Enjoyment) a high score correlates to a high/healthy level of functioning or a better outcome
Time frame: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Population: If participants did not complete the questionnaire or did not complete a question then they are not included in the number analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Arm Symptoms | -2.02 score on a scale | Standard Deviation 11.05 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Breast Symptoms | -1.83 score on a scale | Standard Deviation 11.54 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Upset by Hair Loss | 33.33 score on a scale | — |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Functioning | -4.88 score on a scale | Standard Deviation 17.18 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Enjoyment | 2.38 score on a scale | Standard Deviation 15.82 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Body Image | 2.31 score on a scale | Standard Deviation 10.32 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Systemic Therapy Side Effects | 3.7 score on a scale | Standard Deviation 10.3 |
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Future Perspective | -3.97 score on a scale | Standard Deviation 18.34 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Enjoyment | 4.76 score on a scale | Standard Deviation 25.68 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Breast Symptoms | -3.3 score on a scale | Standard Deviation 15.54 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Body Image | 1.6 score on a scale | Standard Deviation 8.97 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Arm Symptoms | -0.69 score on a scale | Standard Deviation 12 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Systemic Therapy Side Effects | 7.75 score on a scale | Standard Deviation 10.76 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Functioning | -4.35 score on a scale | Standard Deviation 17.72 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Future Perspective | -4.96 score on a scale | Standard Deviation 25.04 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Upset by Hair Loss | 16.67 score on a scale | Standard Deviation 33.33 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Functioning | -3.88 score on a scale | Standard Deviation 14.01 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Systemic Therapy Side Effects | 8.1 score on a scale | Standard Deviation 11.46 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Body Image | 0 score on a scale | Standard Deviation 7.66 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Breast Symptoms | -6.86 score on a scale | Standard Deviation 14.74 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Future Perspective | -2.17 score on a scale | Standard Deviation 23.73 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Upset by Hair Loss | -26.67 score on a scale | Standard Deviation 43.46 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Enjoyment | -2.78 score on a scale | Standard Deviation 26.43 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Arm Symptoms | -0.47 score on a scale | Standard Deviation 15.18 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Functioning | -5.16 score on a scale | Standard Deviation 15.39 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Enjoyment | 0 score on a scale | Standard Deviation 21.82 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Arm Symptoms | -1.45 score on a scale | Standard Deviation 11.14 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Upset by Hair Loss | -20 score on a scale | Standard Deviation 29.81 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Breast Symptoms | -8.76 score on a scale | Standard Deviation 10.44 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Body Image | -0.37 score on a scale | Standard Deviation 10.65 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Systemic Therapy Side Effects | 5.13 score on a scale | Standard Deviation 12.22 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Future Perspective | -7.41 score on a scale | Standard Deviation 24.5 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Breast Symptoms | -10.08 score on a scale | Standard Deviation 11.72 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Body Image | 1.23 score on a scale | Standard Deviation 10.49 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Future Perspective | -6.2 score on a scale | Standard Deviation 31.92 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Systemic Therapy Side Effects | 3.75 score on a scale | Standard Deviation 8.71 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Enjoyment | 5.56 score on a scale | Standard Deviation 19.25 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Arm Symptoms | -3.23 score on a scale | Standard Deviation 14.1 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Functioning | -7.5 score on a scale | Standard Deviation 14.1 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Upset by Hair Loss | 0 score on a scale | Standard Deviation 0 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Breast Symptoms | -9.63 score on a scale | Standard Deviation 13.57 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Enjoyment | 2.56 score on a scale | Standard Deviation 21.35 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Arm Symptoms | -1.89 score on a scale | Standard Deviation 12.33 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Functioning | -0.39 score on a scale | Standard Deviation 19.41 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Systemic Therapy Side Effects | 4.67 score on a scale | Standard Deviation 10.26 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Body Image | 0.66 score on a scale | Standard Deviation 9.45 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Upset by Hair Loss | 0 score on a scale | Standard Deviation 27.22 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Future Perspective | -4.35 score on a scale | Standard Deviation 23.94 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Future Perspective | -7.5 score on a scale | Standard Deviation 26.67 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Body Image | -0.9 score on a scale | Standard Deviation 13.17 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Upset by Hair Loss | -44.44 score on a scale | Standard Deviation 38.49 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Enjoyment | 9.09 score on a scale | Standard Deviation 30.15 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Functioning | -5.41 score on a scale | Standard Deviation 19.66 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Breast Symptoms | -11.04 score on a scale | Standard Deviation 11.94 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Arm Symptoms | -3.52 score on a scale | Standard Deviation 15.8 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Systemic Therapy Side Effects | 2.72 score on a scale | Standard Deviation 7.71 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Body Image | -0.98 score on a scale | Standard Deviation 14.76 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Arm Symptoms | -4.9 score on a scale | Standard Deviation 18.59 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Breast Symptoms | -8.25 score on a scale | Standard Deviation 11.16 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Future Perspective | -11.76 score on a scale | Standard Deviation 29.45 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Enjoyment | -4.76 score on a scale | Standard Deviation 12.6 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Functioning | -4.02 score on a scale | Standard Deviation 23.42 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Systemic Therapy Side Effects | 2.5 score on a scale | Standard Deviation 7.02 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Upset by Hair Loss | 0 score on a scale | Standard Deviation 0 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Enjoyment | -5.56 score on a scale | Standard Deviation 13.61 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Future Perspective | -10.75 score on a scale | Standard Deviation 29.04 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Breast Symptoms | -8.94 score on a scale | Standard Deviation 10.65 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Body Image | -1.61 score on a scale | Standard Deviation 12.98 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Arm Symptoms | -2.08 score on a scale | Standard Deviation 11.79 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Systemic Therapy Side Effects | 3.14 score on a scale | Standard Deviation 10.38 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Upset by Hair Loss | -50 score on a scale | Standard Deviation 23.57 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23 | Sexual Functioning | -1.19 score on a scale | Standard Deviation 21.24 |
Secondary
Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor (0) and severe pain at (10) with the patient's mark providing a range of scores from 0-100 millimeters. A higher score indicates greater pain intensity.
Time frame: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Population: If participants did not complete the questionnaire then they are not included in the number analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (HG-PBI) | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | -0.34 mm | Standard Deviation 0.94 |
| Treatment (HG-PBI) - 8 Weeks | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | -0.14 mm | Standard Deviation 1.29 |
| Treatment (HG-PBI) - 6 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | -0.43 mm | Standard Deviation 1.44 |
| Treatment (HG-PBI) - 12 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | -0.59 mm | Standard Deviation 1.23 |
| Treatment (HG-PBI) - 18 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | -0.67 mm | Standard Deviation 1.49 |
| Treatment (HG-PBI) - 24 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | -0.63 mm | Standard Deviation 1.51 |
| Treatment (HG-PBI) - 36 Months | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | -0.62 mm | Standard Deviation 1.14 |
| Treatment (HG-PBI) - Year 4 | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | -0.6 mm | Standard Deviation 1.29 |
| Treatment (HG-PBI) - Year 5 | Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain | -0.74 mm | Standard Deviation 1.03 |
Secondary
Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale.
Using this scale, cosmesis is qualitatively evaluated by the treating radiation oncologist by comparing the treated breast with the contralateral breast using the Aronson Modified Scale. The global cosmetic result, appearance of the surgical scar, breast size, breast shape, skin color, location of the areola and nipple, and shape of the areola and nipple were scored on a 4-point scale. In this case 1 is 'excellent' with 4 being 'poor.'
Time frame: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5
Population: If physicians did not complete the evaluation with the participant then they are not included in the number analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (HG-PBI) | Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | -0.04 score on a scale | Standard Deviation 0.36 |
| Treatment (HG-PBI) - 8 Weeks | Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | -0.09 score on a scale | Standard Deviation 0.28 |
| Treatment (HG-PBI) - 6 Months | Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | 0.02 score on a scale | Standard Deviation 0.4 |
| Treatment (HG-PBI) - 12 Months | Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | 0.03 score on a scale | Standard Deviation 0.37 |
| Treatment (HG-PBI) - 18 Months | Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | 0 score on a scale | Standard Deviation 0.31 |
| Treatment (HG-PBI) - 24 Months | Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | 0.05 score on a scale | Standard Deviation 0.4 |
| Treatment (HG-PBI) - 36 Months | Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | 0.09 score on a scale | Standard Deviation 0.58 |
| Treatment (HG-PBI) - Year 4 | Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale. | 0.21 score on a scale | Standard Deviation 0.49 |
Secondary
Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA)
This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features.
Time frame: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5
Population: If participants missed the BRA then they are not included in the number analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (HG-PBI) | Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | -0.14 cm | Standard Deviation 1.08 |
| Treatment (HG-PBI) - 8 Weeks | Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | 0.22 cm | Standard Deviation 3.41 |
| Treatment (HG-PBI) - 6 Months | Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | -0.15 cm | Standard Deviation 2.89 |
| Treatment (HG-PBI) - 12 Months | Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | -0.5 cm | Standard Deviation 1.08 |
| Treatment (HG-PBI) - 18 Months | Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | 0.21 cm | Standard Deviation 3.09 |
| Treatment (HG-PBI) - 24 Months | Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | 0.34 cm | Standard Deviation 4.08 |
| Treatment (HG-PBI) - 36 Months | Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA) | 0.91 cm | Standard Deviation 4.85 |
Secondary
Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA)
This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features. This is calculated from dividing the BRA score by the reference length from sternal notch to contralateral nipple and then multiplying that value by 100 to get a percentage.
Time frame: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5
Population: If participants did not have the percentage Breast Retraction Assessment then they are not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (HG-PBI) | Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | -1.05 percentage breast retraction | Standard Deviation 5.14 |
| Treatment (HG-PBI) - 8 Weeks | Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | -0.67 percentage breast retraction | Standard Deviation 10.37 |
| Treatment (HG-PBI) - 6 Months | Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | -1.81 percentage breast retraction | Standard Deviation 9.71 |
| Treatment (HG-PBI) - 12 Months | Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | -2.93 percentage breast retraction | Standard Deviation 5.24 |
| Treatment (HG-PBI) - 18 Months | Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | -1.76 percentage breast retraction | Standard Deviation 9.2 |
| Treatment (HG-PBI) - 24 Months | Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | -1.56 percentage breast retraction | Standard Deviation 11.29 |
| Treatment (HG-PBI) - 36 Months | Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA) | -0.03 percentage breast retraction | Standard Deviation 14.29 |
Secondary
Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0
Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up.
Time frame: Up to 5 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (HG-PBI) | Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0 | Late - white blood cell decreased | 1 Participants |
| Treatment (HG-PBI) | Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0 | Late - fibrosis deep connective tissue | 1 Participants |
| Treatment (HG-PBI) | Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0 | Late - neutrophil count decreased | 1 Participants |
Secondary
Number of Patients With Complications Using CTCAE v. 4.0
Acute complications are defined as complications that occurred from start of treatment until day 90. Late complications are defined as complications that occurred from Day 91 until completion of 5 year follow-up.
Time frame: Up to 5 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Alkaline phosphatase increased | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Poor dentition | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Chest pain - Cardiac | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Headache | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Trigger finger | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Heart Failure | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Chest Wall Pain | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Hematoma | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Alopecia | 3 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Hot Flashes | 13 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Chills | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Hyperhidrosis | 10 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Vertigo | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Hyperkalemia | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Chronic kidney disease | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Hypertension | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Anemia | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Candida infection | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Constipation | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | COVID-19 infection | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Shingles | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Insomnia | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Cough | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Irritability | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Arthralgia | 6 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Joint infection | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Depression | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Memory Impairment | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Dry Mouth | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Shoulder pain | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Diarrhea | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Myocardial Infarction | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Ataxia | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Nausea | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Dizziness | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Neck Pain | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Dry Skin | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Neutrophil Count Decreased | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Vomiting | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Nipple deformity | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Dyspnea | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Pain in extremity | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Atrial Fibrillation | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Pain | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Edema Limbs | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Pericardial Effusion | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Breast Atrophy | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Platelet Count decrease | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Ejection fraction decreased | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Seroma | 3 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Scar retraction | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Skin Atrophy | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Epistaxis | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Skin Hyperpigmentation | 15 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Breast Pain | 3 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Skin Induration | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Fall | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Skin Infection | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Back Pain | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Superficial soft tissue fibrosis | 3 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Fatigue | 2 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Telangiectasia | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Bronchial Infection | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Thrombotic event | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Fibrosis deep connective tissue | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Tremor | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | White blood cell decrease | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Upper respiratory Infection | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Flank Pain | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Urticaria | 1 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Congestive heart failure | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Vaginal Pain | 0 Participants |
| Treatment (HG-PBI) | Number of Patients With Complications Using CTCAE v. 4.0 | Gastroesophageal reflux disease | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Vaginal Pain | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Vertigo | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | White blood cell decrease | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Shingles | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Scar retraction | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Trigger finger | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Dizziness | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Dry Mouth | 2 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Atrial Fibrillation | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Back Pain | 4 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Alkaline phosphatase increased | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Alopecia | 3 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Anemia | 2 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Arthralgia | 30 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Ataxia | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Breast Atrophy | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Breast Pain | 7 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Bronchial Infection | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Congestive heart failure | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Chest pain - Cardiac | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Chest Wall Pain | 0 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Chills | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Chronic kidney disease | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Constipation | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Cough | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Depression | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Diarrhea | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Dry Skin | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Dyspnea | 4 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Edema Limbs | 3 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Ejection fraction decreased | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Epistaxis | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Fall | 2 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Fatigue | 4 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Fibrosis deep connective tissue | 24 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Flank Pain | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Gastroesophageal reflux disease | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Poor dentition | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Headache | 0 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Heart Failure | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Hematoma | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Hot Flashes | 34 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Hyperhidrosis | 22 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Hyperkalemia | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Hypertension | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Candida infection | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | COVID-19 infection | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Insomnia | 3 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Irritability | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Joint infection | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Memory Impairment | 3 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Shoulder pain | 0 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Myocardial Infarction | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Nausea | 0 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Neck Pain | 2 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Neutrophil Count Decreased | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Nipple deformity | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Pain in extremity | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Pain | 0 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Pericardial Effusion | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Platelet Count decrease | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Seroma | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Skin Atrophy | 5 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Skin Hyperpigmentation | 16 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Skin Induration | 4 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Skin Infection | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Superficial soft tissue fibrosis | 7 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Telangiectasia | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Thrombotic event | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Tremor | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Upper respiratory Infection | 1 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Urticaria | 0 Participants |
| Treatment (HG-PBI) - 8 Weeks | Number of Patients With Complications Using CTCAE v. 4.0 | Vomiting | 0 Participants |
Secondary
Percentage of Patients Undergoing Mastectomy on the Treated Side
Time frame: At 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (HG-PBI) | Percentage of Patients Undergoing Mastectomy on the Treated Side | 1 Participants |
Secondary
Percentage of Patients Who Are Free From Distant Metastases
Time frame: At 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (HG-PBI) | Percentage of Patients Who Are Free From Distant Metastases | 49 Participants |
Secondary
Percentage of Patients Who Are Free of Breast Cancer in the Regional Lymph Nodes
Ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups.
Time frame: At 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (HG-PBI) | Percentage of Patients Who Are Free of Breast Cancer in the Regional Lymph Nodes | 49 Participants |