CLINICAL TRIAL

Radiation Therapy for Breast Cancer

Stage I
Waitlist Available · 18+ · Female · Milford, MA

This study is evaluating whether a shorter course of radiation therapy is as effective as a longer course of radiation therapy for women who have undergone mastectomy and immediate breast reconstruction.

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About the trial for Breast Cancer

Eligible Conditions
Breast Cancer · Breast Neoplasms

Treatment Groups

This trial involves 2 different treatments. Radiation Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Radiation Therapy
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Radiation Therapy
RADIATION

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2005
Completed Phase 3
~7080

Eligibility

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age ≥18
Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3 tumor Has been treated with mastectomy
Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy
Is a candidate for unilateral post-mastectomy radiation therapy as per National Comprehensive Cancer Network (NCCN) guidelines (post-mastectomy radiation therapy is indicated for most patients with positive lymph nodes at time of surgery and infrequently for selected node-negative patients)
Use of bolus is permitted, but not required
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 10 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 10 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Radiation Therapy will improve 1 primary outcome and 2 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 6 months.

Patient reported outcomes using the FACT-B
6 MONTHS
The primary outcome is the change at 6 months from baseline in patient-reported outcomes on the Physical Well Being sub-domain of the FACT-B.
6 MONTHS
Cosmetic outcomes assessed using photographic evaluations.
18 MONTHS
Cosmetic outcomes (quality of reconstructive surgery throughout and after radiation therapy) will be assessed from baseline to 18 months by trained physicians using a standardized rating scale.
18 MONTHS
Oncologic and clinical outcomes assessed using medical record abstractions.
10 YEARS
Clinical and oncologic outcomes (rare radiation side effects, recurrence, infections, additional surgeries) will be assessed over a period of 10 years through annual medical record abstractions.
10 YEARS

Who is running the study

Principal Investigator
R. P.
Rinaa Punglia, MD
Dana-Farber Cancer Institute

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?

Around 1.4 million cases of breast cancer are diagnosed each year in the United States. In 2015, more than 1.7 million women were diagnosed with breast cancer. This disease is the leading cause of death among white, middle-aged women.

Anonymous Patient Answer

What causes breast cancer?

Several risk factors are known to increase the risk of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), including a family history of the disease. However, the cause of breast cancer is not known. However, certain cancer-related processes (e.g., the effects of hormones and genetics) are likely to increase the risk through alterations in the cell biology of cells, resulting in cells in the breast becoming more likely to grow and form tumors. Many of the genes involved in breast cancer initiation and progression are still unknown.\n

Anonymous Patient Answer

What is breast cancer?

Breast cancer is, by far, the most common cancer diagnosed in women in Europe. In the United Kingdom, breast cancer is the third most common cancer in both males and females and the leading cause of cancer death for females. This disease presents a particular challenge as women with the disease are typically young and live a long life. Breast cancer remains a major public health issue in the UK with an estimated 5,200 new cases diagnosed in 2011.

Anonymous Patient Answer

What are the signs of breast cancer?

Symptoms of breast cancer last for 6 months or more and usually include pain when touched, which represents a new symptom and becomes one of the first symptoms of breast cancer. Other symptoms frequently include nipple discharge of an unknown nature, which has to be tested, as not all women have breast cancer and it is recommended that they are only checked every three to five months. Some women have no symptoms and those with early stage breast cancer can be reassured. One study identified a large proportion of women as initially suffering from the early stage disease; it is unclear whether these women had symptoms but they were overlooked due to the lack of knowledge about screening. It is believed that these women could be treated earlier and have a better chance of survival.

Anonymous Patient Answer

What are common treatments for breast cancer?

Women with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) need to have their tumours removed by radical mastectomy, either by surgery or with a mastectomy. Women also need chemotherapy before surgery and if surgery is not possible then they will need radiation or hormone therapy for at least 5 years to treat their cancer. A routine course of chemotherapy before surgery helps stop local recurrence or spread of breast cancer. Surgery alone improves survival by removing the cancer, but it does not cure women with breast cancer. Chemotherapy and radiotherapy are used after surgery to prevent metastasis of cancer to nearby sites of the body such as to areas in the chest and bones. Most women with breast cancer who are node-negative and who have not been treated with radiation or chemotherapy have a good life span.

Anonymous Patient Answer

Can breast cancer be cured?

Breast cancer cannot be cured. It can be delayed and controlled, but not eliminated. Breast cancer patients with node-negative disease do better, regardless of size or stage. But breast cancer patients with node-positive disease do not. There is no evidence that any cure exists for any subset of patients.

Anonymous Patient Answer

How quickly does breast cancer spread?

The cancer cells at this point may either be alive or dead. As the cells die, they may release a variety of proteins, chemokines, cytokines and growth factors. These factors are of the signaling and regulatory kinds, so their effects on neighboring cells is complex. This is also the case with metastasis, in which tumor cells at the site of primary tumor are capable of migrating to other organs, either by migration or dissemination.\n\nThis is a discussion of the different types of tumors in breast cancer staging and is based on the TNM system of staging. When breast cancer is newly diagnosed, staging is crucial to deciding how best to treat it.

Anonymous Patient Answer

What are the latest developments in radiation therapy for therapeutic use?

RT can be used in many clinical situations, with high rates of local control obtained in almost all patients who received RT, although one third of these patients were treated with a low fraction schedule (1.25Gy) or with a sequential schedule of two fractions given every other day. The rates obtained of long-term local control and survival are comparable to those reported using standard fractionation when high doses are included in RT.

Anonymous Patient Answer

Does radiation therapy improve quality of life for those with breast cancer?

The use of radiation therapy to treat breast cancer has had benefits not only in loco-regional control, distant control, and disease-free survival, but also in QoL for survivors.

Anonymous Patient Answer

What does radiation therapy usually treat?

Radiation therapy is often used to treat “everything”. It’s not an “area” – it’s “everywhere”. There’s no reason why it can’t be used “only” for certain things, such as only for “recurrent, local,” “infiltrating,” “metastatic,” locally advanced, or “sentinel-node-positive” breast cancer; yet many patients who are “fought” to death with chemotherapy have gone into remission thanks to radiation therapy.

Anonymous Patient Answer

Who should consider clinical trials for breast cancer?

Recent findings demonstrates that the choice of the clinical trial protocol (phase II and III) is a central decision-making factor in the use of these protocols in clinical practice as it determines the likelihood that an appropriate and efficacious treatment will be developed.

Anonymous Patient Answer

How serious can breast cancer be?

It is possible to die from [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), especially with recurrence, even when the disease is discovered early. It is just as possible to live for decades without symptoms. The difference between life and death is a matter of how much quality of life can be regained after the cancer attacks. As a group, women with breast cancer seem to be in reasonably good health and do not seem to have high mortality rates. But even if survival is good, cancer is always very debilitating.

Anonymous Patient Answer
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