Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
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| ClinicalTrials.gov Identifier: NCT03422003 |
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Recruitment Status :
Active, not recruiting
First Posted : February 5, 2018
Last Update Posted : November 22, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Radiation: Radiation Therapy | Not Applicable |
Over 180,000 diagnoses of invasive breast cancer are made in the US each year. Over one-third of women with early stage and over half with late-stage breast cancer are treated with mastectomy (removal of the entire breast) due to tumor size, multiple cancers within the breast, genetic cancer predisposition, and/or patient preference. Following treatment with mastectomy, women who receive breast reconstructive surgery may experience better quality of life as they do not have to leave surgery with a bare chest wall. However, large randomized trials of post-mastectomy radiation therapy reveal a survival benefit with the addition of radiation after mastectomy in women who have cancer present in the axillary lymph nodes (6). The delivery of radiation therapy in the presence of a breast reconstruction is challenging and often leads to undesirable consequences including reconstruction loss, need for major surgical revision, or poor cosmetic outcomes. Therefore, oncologists and patients are forced to decide between the potential for improved oncologic outcomes with radiation therapy versus increased likelihood of complications and suboptimal cosmetic results. Because of this, some patients may be foregoing reconstruction if radiation therapy after mastectomy is needed; or foregoing radiation therapy if they have had breast reconstructive surgery (28).
Hypofractionation enhances patient convenience and decreases treatment burden. This regimen has been shown in randomized trials largely in the breast-conservation setting to reduce acute radiation therapy side-effects, decrease fatigue at six months and improve cosmetic results (21, 22). Despite these results, adoption of hypofractionation has been slow among women with breast cancer treated with breast-conserving surgery (24, 25) likely due to familiarity and experience of conventional long-course radiation therapy.
While hypofractionation is used commonly in the UK for patients with mastectomy, there are no randomized studies particularly studying outcomes following shorter course radiation therapy in women who undergo mastectomy with breast reconstruction. Therefore, there is an even greater barrier to the use of hypofractionation in this setting in the US. With improved cosmetic results found with hypofractionation, this shorter regimen may have the potential to improve reconstruction success rates which are unfortunately modest overall, for patients who require post-mastectomy radiation. Especially in contrast to financial disincentives to reduce number of radiation treatments, Level I randomized evidence is needed in this population to change practice patterns regarding radiation regimen.
Our study of radiation fractionation regimens has the potential to increase use of hypofractionation among women treated with mastectomy, thereby decreasing treatment burden. Our team of patient stakeholders ensures that our outcomes measures encompass all domains of survivorship after breast cancer (physical and mental health as well as satisfaction with the decision-making process). Despite the large numbers of breast cancer survivors who undergo mastectomy, reconstruction and radiation therapy, little is known about which domains of quality of life are affected and their importance to these patients. This study uses previously validated tools for measuring patient outcomes, and have added questions for areas which are important to patients that may not have been captured adequately by previous tools. In concert with the increasing awareness of the importance of survivorship care to cancer care, identifying a comprehensive set of outcomes measurement tools following treatment with radiation therapy, mastectomy, and reconstruction is an important asset for future treatment evaluation in these women.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 400 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma |
| Actual Study Start Date : | April 1, 2018 |
| Actual Primary Completion Date : | October 31, 2023 |
| Estimated Study Completion Date : | April 1, 2030 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1: Hypofractionation
16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.
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Radiation: Radiation Therapy
For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes. For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes. |
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Active Comparator: Arm 2: Conventional Radiation Therapy
25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.
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Radiation: Radiation Therapy
For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes. For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes. |
- Patient reported outcomes using the FACT-B [ Time Frame: 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.
- Oncologic and clinical outcomes assessed using medical record abstractions. [ Time Frame: 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.
- Cosmetic outcomes assessed using photographic evaluations. [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Age ≥18
Exclusion Criteria:
- T4 cancer
- Recurrent breast cancer or history of prior breast radiation therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or mental health illness that the consenting investigator feels would affect patient's ability to participate in this study
- Pregnant or nursing
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History of a different malignancy except for the following circumstances:
- Disease-free for at least five years and deemed by the investigator to be at low risk for recurrence of that malignancy (<5 %).
- Cervical cancer in situ and basal cell or squamous cell carcinoma of the skin
- Breast cancer requiring bilateral breast/chest wall radiation therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422003
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94115 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Vail Health | |
| Edwards, Colorado, United States, 81632 | |
| United States, Connecticut | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06511 | |
| United States, District of Columbia | |
| Johns Hopkins Medicine | |
| Washington, District of Columbia, United States, 20016 | |
| United States, Maine | |
| Eastern Maine Medical Center | |
| Brewer, Maine, United States, 04412 | |
| Maine Medical Center | |
| Scarborough, Maine, United States, 04074 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| Massachusetts General Hospital/North Shore Center for Outpatient Care | |
| Danvers, Massachusetts, United States, 01923 | |
| Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center | |
| Milford, Massachusetts, United States, 01757 | |
| Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital | |
| South Weymouth, Massachusetts, United States, 02190 | |
| United States, Rhode Island | |
| Lifespan/Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98109 | |
| Study Chair: | Rinaa Punglia, MD MPH | Dana-Farber Cancer Institute | |
| Study Chair: | Julia Wong, MD | Dana-Farber Cancer Institute |
| Responsible Party: | Rinaa Punglia, MD, MPH, Prinicipal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT03422003 |
| Other Study ID Numbers: |
16-304 |
| First Posted: | February 5, 2018 Key Record Dates |
| Last Update Posted: | November 22, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Breast Cancer Radiation Hypofractionation Randomization |
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Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |