NCT02086578

Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions

Completed Phase 2 Results posted Last updated 20 January 2026

What this trial tests

Phase 2 trial testing Breast MRI in Breast Cancer in 100 participants. Completed in 13 September 2024.

Timeline

11 March 2014

Primary endpoint
13 September 2024

13 September 2024

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	11 March 2014
Primary completion	13 September 2024
Estimated completion	13 September 2024
Sites	7 locations across United States

Drugs / interventions tested

• Breast MRI
• Breast-Q© questionnaire
• Multi-Beam IMRT

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Implant Failure Primary · 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).

Implant Failure

Group	Value	95% CI
IMRT to Temporary Expander	8
IMRT to Permanent Implant	17

No Implant Failure

Group	Value	95% CI
IMRT to Temporary Expander	34
IMRT to Permanent Implant	41

Incidence of Moderate to Severe Capsular Contracture Secondary · 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.

Group	Value	95% CI
IMRT to Temporary Expander	26
IMRT to Permanent Implant	36
IMRT to Temporary Expander	16
IMRT to Permanent Implant	11
IMRT to Temporary Expander	0
IMRT to Permanent Implant	11

Rates of Minor Revisional Surgeries Secondary · 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.

Group	Value	95% CI
IMRT to Temporary Expander	0
IMRT to Permanent Implant	2
IMRT to Temporary Expander	42
IMRT to Permanent Implant	56

Evaluate Cosmesis Secondary · 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 indica

Baseline Physical Well Being Abdomen

Group	Value	95% CI
Arm 1: IMRT to Temporary Expander	84	76 – 92
Arm 2: IMRT to Permanent Implant	64	59 – 92

Follow-up 1 Physical Well Being Abdomen-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)

Group	Value	95% CI
Arm 1: IMRT to Temporary Expander	70	53 – 74
Arm 2: IMRT to Permanent Implant	59	47 – 70

Follow-up 2 Physical Well Being Abdomen-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)

Group	Value	95% CI
Arm 1: IMRT to Temporary Expander	76	62 – 79
Arm 2: IMRT to Permanent Implant	69	46 – 82

Follow-up 3 Physical Well Being Abdomen-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)

Group	Value	95% CI
Arm 1: IMRT to Temporary Expander	69	45 – 72
Arm 2: IMRT to Permanent Implant	50	0 – 75

Baseline Physical Well Being Chest

Group	Value	95% CI
Arm 1: IMRT to Temporary Expander	68	58 – 83
Arm 2: IMRT to Permanent Implant	60	55 – 67

Follow-up 1 Physical Well Being Chest-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)

Group	Value	95% CI
Arm 1: IMRT to Temporary Expander	61	50 – 74
Arm 2: IMRT to Permanent Implant	63	53 – 84

Follow-up 2 Physical Well Being Chest-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)

Group	Value	95% CI
Arm 1: IMRT to Temporary Expander	66	57 – 85
Arm 2: IMRT to Permanent Implant	72	58 – 81

Follow-up 3 Physical Well Being Chest-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)

Group	Value	95% CI
Arm 1: IMRT to Temporary Expander	68	50 – 88
Arm 2: IMRT to Permanent Implant	68	60 – 92

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IMRT to Temporary Expander

Serious: 3/42 (7%)

Deaths: 0/42

IMRT to Permanent Implant

Serious: 15/58 (26%)

Deaths: 8/58

Serious adverse events (15 terms)

Reaction	System	IMRT to Temporary Expander	IMRT to Permanent Implant
Breast infection	Infections and infestations	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Wound infection	Infections and infestations	—	—
Breast pain	Reproductive system and breast disorders	—	—
Chest pain - cardiac	Cardiac disorders	—	—
Chest wall pain	Musculoskeletal and connective tissue disorders	—	—
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Infections and infestations - Other, specify	Infections and infestations	—	—
Nausea	Gastrointestinal disorders	—	—
Non-cardiac chest pain	General disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—
Skin infection	Infections and infestations	—	—
Wound dehiscence	Injury, poisoning and procedural complications	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	IMRT to Temporary Expander	IMRT to Permanent Implant
Lymphocyte count decreased	Investigations	—	—
White blood cell decreased	Investigations	—	—
Neutrophil count decreased	Investigations	—	—
Anemia	Blood and lymphatic system disorders	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Blood bilirubin increased	Investigations	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—
Platelet count decreased	Blood and lymphatic system disorders	—	—

Most-reported serious reactions: Breast infection, Dyspnea, Wound infection, Breast pain, Chest pain - cardiac, Chest wall pain, Gastrointestinal disorders - Other, specify, Hypoxia.

Data from ClinicalTrials.gov NCT02086578 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.