Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma

NCT03422003 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: 16-304
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 15

Brief Summary

This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side effects, and oncologic outcomes.

Conditions

Breast Cancer

Keywords

Breast Cancer; Radiation; Hypofractionation; Randomization

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcomes Using the FACT-B

  The primary outcome is the change at 6 months from baseline in patient-reported outcomes on the Physical Well Being (PWB) sub-domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument. The FACT-B is a 37-item instrument designed to measure five domains of health-related quality of life in breast cancer patients. The higher the score, the better the quality of life. Score ranges: * The score range for the FACT-B total score is 0-148. * The score range for the PWB, social/family well-being (SWB), and functional well-being (FWB) subscales is 0-28. * The score range for the emotional well-being (EWB) subscale is 0-24. * The score range for the breast cancer subscale (BCS) is 0-40.

  6 months

Secondary Outcomes (2)

• Oncologic and Clinical Outcomes Assessed Using Medical Record Abstractions.

  10 years

• Cosmetic Outcomes Assessed Using Photographic Evaluations.

  18 months

Study Arms (2)

Arm 1: Hypofractionation

EXPERIMENTAL

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.

Radiation: Radiation Therapy

Arm 2: Conventional Radiation Therapy

ACTIVE COMPARATOR

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.

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

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.

Arm 1: Hypofractionation; Arm 2: Conventional Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (15)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Vail Health

Edwards, Colorado, 81632, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Johns Hopkins Medicine

Washington D.C., District of Columbia, 20016, United States

Location

Eastern Maine Medical Center

Brewer, Maine, 04412, United States

Location

Maine Medical Center

Scarborough, Maine, 04074, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital/North Shore Center for Outpatient Care

Danvers, Massachusetts, 01923, United States

Location

Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center

Milford, Massachusetts, 01757, United States

Location

Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital

South Weymouth, Massachusetts, 02190, United States

Location

Lifespan/Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (7)

• EBCTCG (Early Breast Cancer Trialists' Collaborative Group); McGale P, Taylor C, Correa C, Cutter D, Duane F, Ewertz M, Gray R, Mannu G, Peto R, Whelan T, Wang Y, Wang Z, Darby S. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014 Jun 21;383(9935):2127-35. doi: 10.1016/S0140-6736(14)60488-8. Epub 2014 Mar 19.

  PMID: 24656685 BACKGROUND

• Duxbury PJ, Gandhi A, Kirwan CC, Jain Y, Harvey JR. Current attitudes to breast reconstruction surgery for women at risk of post-mastectomy radiotherapy: A survey of UK breast surgeons. Breast. 2015 Aug;24(4):502-12. doi: 10.1016/j.breast.2015.05.002. Epub 2015 May 26.

  PMID: 26021276 BACKGROUND

• START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19.

  PMID: 18356109 BACKGROUND

• Shaitelman SF, Schlembach PJ, Arzu I, Ballo M, Bloom ES, Buchholz D, Chronowski GM, Dvorak T, Grade E, Hoffman KE, Kelly P, Ludwig M, Perkins GH, Reed V, Shah S, Stauder MC, Strom EA, Tereffe W, Woodward WA, Ensor J, Baumann D, Thompson AM, Amaya D, Davis T, Guerra W, Hamblin L, Hortobagyi G, Hunt KK, Buchholz TA, Smith BD. Acute and Short-term Toxic Effects of Conventionally Fractionated vs Hypofractionated Whole-Breast Irradiation: A Randomized Clinical Trial. JAMA Oncol. 2015 Oct;1(7):931-41. doi: 10.1001/jamaoncol.2015.2666.

  PMID: 26247543 BACKGROUND

• Bekelman JE, Sylwestrzak G, Barron J, Liu J, Epstein AJ, Freedman G, Malin J, Emanuel EJ. Uptake and costs of hypofractionated vs conventional whole breast irradiation after breast conserving surgery in the United States, 2008-2013. JAMA. 2014 Dec 17;312(23):2542-50. doi: 10.1001/jama.2014.16616.

  PMID: 25494006 BACKGROUND

• Jagsi R, Falchook AD, Hendrix LH, Curry H, Chen RC. Adoption of hypofractionated radiation therapy for breast cancer after publication of randomized trials. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1001-9. doi: 10.1016/j.ijrobp.2014.09.032.

  PMID: 25539365 BACKGROUND

• Wong JS, Uno H, Tramontano AC, Fisher L, Pellegrini CV, Abel GA, Burstein HJ, Chun YS, King TA, Schrag D, Winer E, Bellon JR, Cheney MD, Hardenbergh P, Ho A, Horst KC, Kim JN, Leonard KL, Moran MS, Park CC, Recht A, Soto DE, Shiloh RY, Stinson SF, Snyder KM, Taghian AG, Warren LE, Wright JL, Punglia RS. Hypofractionated vs Conventionally Fractionated Postmastectomy Radiation After Implant-Based Reconstruction: A Randomized Clinical Trial. JAMA Oncol. 2024 Oct 1;10(10):1370-1378. doi: 10.1001/jamaoncol.2024.2652.

  PMID: 39115975 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Rinaa Punglia
• Organization: Dana-Farber Cancer Institute

rpunglia@mgb.org

617-632-3591

Study Officials

• Rinaa Punglia, MD MPH

  Dana-Farber Cancer Institute

  STUDY CHAIR

• Julia Wong, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 5, 2018
• Study Start: April 1, 2018
• Primary Completion: October 31, 2023
• Study Completion (Estimated): April 1, 2030
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)