Breast Cancer
Conditions
Keywords
multi-beam Intensity-Modulated Radiation Therapy (IMRT), 14-028
Brief summary
The purpose of this study is to determine if a radiation treatment called "Multi-beam Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant if they are a candidate for radiation therapy. Currently, the standard method of giving radiation is with "3D radiation", which only uses 2-5 beams of radiation. "Multi-beam" IMRT works by using 8-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is to reduce complications after irradiation to the implants. The study doctors have recently completed a trial using this technique and are now specifically looking at its impact on women with implant reconstructions who are undergoing post-mastectomy radiation therapy. By delivering a more "customized" dose of radiation to the implant, the intent is to reduce side effects of radiation on the implant.
Detailed description
Patients will undergo mastectomy and axillary dissection with immediate tissue expander placement. As is the current practice at MSKCC, patients receiving adjuvant chemotherapy will undergo expansion during chemotherapy, with exchange for a permanent implant to be performed approximately one month after chemotherapy and radiation to begin approximately one month after exchange. Patients who receive neoadjuvant chemotherapy will undergo "rapid expansion" of the expander and begin radiation at least 4 weeks following surgery, although it may be performed sooner if the patient has recovered from surgery and the treating physician deems it safe to proceed with treatment. In these patients, exchange for the permanent implant will occur at the discretion of the treating plastic surgeon (approximately 5-8 months after the end of radiation).
Interventions
DEVICEBreast MRI
BEHAVIORALBreast-Q© questionnaire
RADIATIONMulti-Beam IMRT
The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years * Histologically-confirmed invasive breast cancer by MSKCC * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Status post mastectomy with surgical assessment of axillary nodes * Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to RT performed at MSKCC * If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.
Exclusion criteria
* Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2) * Pregnant or breastfeeding. * Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires. * Prior radiation therapy to the ipsilateral breast/nodes or thorax. * The criterias outlined above apply to the patients enrolled to meet the primary objective of the study. Additional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Implant Failure | 24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2 | The multi-beam IMRT would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Moderate to Severe Capsular Contracture | 24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2 | Will be examined using number of participants who developed Baker's grade \<2 and ≥2 capsular contracture, respectively, at 12 or 18 months and 24 or 30 months after IMRT was administered. Participants were assigned a Baker Classification score (a standardized 4-point scale, which integrates the texture and appearance of the breast) at baseline and each follow-up interval by the radiation oncologist or plastic surgeon (the higher of the 2 was used if the score was discordant). Significant capsular contracture is measured as Baker grade III or IV. |
| Rates of Minor Revisional Surgeries | 2 years | Incidence of minor revisional surgeries by plastic surgeon will be evaluated by proportions too. Again, the rates (proportions) will be compared across the two groups. |
| Evaluate Cosmesis | Baseline, Follow-up 1 (Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)), Follow-up 2 (Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)), and Follow-up 3 (Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)) | To evaluate cosmesis, the Breast-Q© will be utilized in these assessments and will be presented descriptively, giving summary statistics for changes in the Breast-Q© scores over time. With a focus on the post-operative period, the module will evaluate changes over time in four of the six subthemes identified by Breast-Q: (1) Psychosocial well-being; (2) Physical well-being; (3) Satisfaction with breasts; and (4) Satisfaction with outcome. Each subtheme will be evaluated using one or more scales. Each scale is independently scored into a value that ranges from 0 to 100, with higher score indicating greater satisfaction or better health-related quality of life. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaphna Gelblum, MD
Memorial Sloan Kettering Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 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 | 7 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Region of Enrollment United States | 100 Participants |
| Sex: Female, Male Female | 100 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 / 42 | 8 / 58 |
| other Total, other adverse events | 32 / 42 | 58 / 58 |
| serious Total, serious adverse events | 3 / 42 | 15 / 58 |
Outcome results
None listed