Quality-of-Life Assessment for Breast Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Baptist - MD Anderson Cancer Center, Jacksonville, FL
Breast Cancer+9 More
Quality-of-Life Assessment - Other
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a shorter radiation treatment schedule may help reduce the risk of lymphedema for women who need radiation therapy to their lymph nodes as part of their breast cancer treatment.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Stage IIIC Breast Cancer AJCC v7
  • Stage IA Breast Cancer AJCC v7
  • Stage II Breast Cancer AJCC v6 and v7
  • Stage IIA Breast Cancer AJCC v6 and v7
  • Invasive Breast Carcinoma
  • Stage I Breast Cancer AJCC v7
  • Stage IB Breast Cancer AJCC v7
  • Stage IIB Breast Cancer AJCC v6 and v7
  • Stage IIIA Breast Cancer AJCC v7

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Quality-of-Life Assessment will improve 1 primary outcome and 1 secondary outcome in patients with Breast Cancer. Measurement will happen over the course of Up to 24 months.

Up to 126 months
Volume of affected and unaffected arm as assessed by perometry
Up to 24 months
Lymphedema rate as assessed by perometry

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Arm II: Standard Regional Nodal Irradiation (RNI)
Arm I: Hypofractionated Regional Nodal Irradiation (RNI)

This trial requires 290 total participants across 2 different treatment groups

This trial involves 2 different treatments. Quality-of-Life Assessment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm I: Hypofractionated Regional Nodal Irradiation (RNI)Patients undergo hypofractionated RNI in 15 fractions 5 consecutive days a week for 3 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.
Arm II: Standard Regional Nodal Irradiation (RNI)Patients undergo standard RNI in 25 fractions 5 consecutive days a week for 5 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 126 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 126 months for reporting.

Closest Location

Baptist - MD Anderson Cancer Center - Jacksonville, FL

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
is required for patients undergoing postoperative radiation therapy show original
at the time of registration Someone who has had cancer in the past and has completed all treatment for that cancer is allowed to participate in a study that is testing radiation therapy for breast cancer as long as they have no evidence of disease at the time of registration. show original
If the patient has a history of a prior cancer, radiation therapy for that cancer must be completed before the patient can join this study show original
to surgical oncologist The surgeon and radiation oncologist recommend that the surgical oncologist preoperatively radiation therapy. show original
The radiation oncologist recommends radiation treatment to the supraclavicular and infraclavicular fossa, which is also known as RNI. show original
Patients with invasive breast cancer who undergo surgery should receive postoperative radiation therapy if their pathologic stage is T0-T3, N0-N2a or N3a show original
If you have surgery to remove your breast cancer (mastectomy or segmental mastectomy), you may need radiation therapy after your surgery show original
People who have surgery to remove breast cancer and then radiation therapy must enroll in a clinical trial within 12 weeks of their surgery or the last chemotherapy treatment cycle. show original
PREOPERATIVE RADIATION THERAPY: Pathologically-confirmed invasive breast cancer. The clinical stage must be T0-T3, N0-N3a
Preoperative radiation therapy is a planned treatment that includes a mastectomy and axillary evaluation show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get breast cancer a year in the United States?

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Only about 7% got it. People who get it are about 4 to 6 years younger at the time of diagnosis. They are more likely to have been diagnosed with breast cancer at a younger age, and they are more likely to be African American and less likely to be college-educated.

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What is breast cancer?

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For women over the age of 60 years, [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is the second leading cause of cancer death in the US. Risk for breast cancer is influenced by a combination of environment and genetics.

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What causes breast cancer?

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Although there are multiple causes of breast cancer, it appears that environmental exposures, including radiation, chemicals, and hormones, play a role in women's breast cancer risk. Smoking does not alter the risk of breast cancer.

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Can breast cancer be cured?

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While it is impossible to cure [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), some patients do appear to be cured. Some have even undergone treatments for years in the belief that their disease is controlled, only to regain their cancer and be diagnosed again. Others only have had minor, early recurrences of cancer, such as at a local location, and feel that treatment of their cancer is unnecessary and unnecessarily stressful on their body. Some patients with distant, metastatic disease are known to have survived indefinitely, either due to their cancer recurrences being limited to less malignant parts of their body, or due to other unknown factors.

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What are the signs of breast cancer?

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Some of the first noticeable signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include: lump or mass, nipple discharge, changes to or enlargement of the breast or the sensation that your breast is lumpy or has changed. A family history of breast cancer or breast disease also increases the likelihood of finding breast cancer. Younger individuals are also more likely to have symptoms, with about two in ten individuals being symptomatic, compared with around three in ten on average for those over 65 years of age. Women who are breast cancer survivors are at increased risk of breast cancer. For younger patients, a positive family history can increase the risk by as much as ten-fold.

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What are common treatments for breast cancer?

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Tumor size at diagnosis influences clinical outcomes and treatment; a good surgical resection is one of three main factors that determine survival rate. Chemotherapy and radiotherapy can minimize side effects and increase quality of life. Breast reconstruction is very important and may be used in some cases. Clinical trial design should consider the tumor size at diagnosis.

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Does quality-of-life assessment improve quality of life for those with breast cancer?

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Patients diagnosed with breast cancer report increased quality of life after treatment, compared with patients reporting similar quality of life before diagnosis. QOL is perceived as highly valued by patients diagnosed with breast cancer.

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Who should consider clinical trials for breast cancer?

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It may not be possible to identify and target specific populations for breast cancer clinical trials, especially among women with a history of breast cancer and survivors, particularly those with recurrent disease who wish to avoid treatment as a risk factor for future recurrences. These women could possibly benefit from prospective studies, while minimizing the impact of potential adverse events from treatment decisions to be made in the absence of reliable information about long-term benefits and risks of treatment options for recurrent disease in particular.

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Have there been other clinical trials involving quality-of-life assessment?

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The development of a clinical trial quality of life instrument should begin at its end. We believe our instrument may have the potential for use in the next generation of trials on the treatment of cancer; however, additional validation is necessary before its use in clinical trials is contemplated.

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What is the average age someone gets breast cancer?

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Contrary to popular opinion, women undergoing [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) treatment are generally not a younger generation of women than women not diagnosed and treated with cancer. The mean age for breast cancer survivors in the United States is 61.5 years. The average age of diagnosis is 49.6 years of age for women diagnosed with invasive carcinoma/metastatic breast cancer. For those women found to have synchronous or metachronous breast cancer, the average age diagnosed and treated is 50.9 years. The age group with the highest incidence of breast cancer among women diagnosed was the 80 years and older age group. Women over the age of 90 years accounted for a majority of breast cancer deaths among whites, African Americans, and Hispanics.

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What is the latest research for breast cancer?

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The research results published in journals, book and other sources continue to be updated constantly. It is not possible to summarize all the relevant data at this stage, although it is possible to summarize selected areas and list the main sources of relevant information.

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What is quality-of-life assessment?

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QoL measurement can be used to capture the patient's perspective. While the most obvious outcome measurements tend to overestimate the magnitude of the impact of treatment for some patients, it is possible to measure QoL, as a surrogate outcome for outcomes not easily measured, particularly in some rare types of cancer.

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