Trial Outcomes & Findings for MRI-Based Preoperative Accelerated Partial Breast Irradiation (NCT NCT02728076)

NCT ID: NCT02728076

Last Updated: 2025-01-22

Results Overview

The number of subjects with one or more postoperative complications following preoperative accelerated partial breast irradiation within three months of surgery.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: 3 Months
• Results posted on: 2025-01-22

Participant Flow

Participant milestones

Measure	Radiation Therapy Followed by Lumpectom Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy Phase II - Preoperative Radiation followed by Lumpectomy.: Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.
Overall Study STARTED	39
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure

Radiation Therapy Followed by Lumpectom Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy Phase II - Preoperative Radiation followed by Lumpectomy.: Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.

Overall Study Physician Decision

4

Baseline Characteristics

MRI-Based Preoperative Accelerated Partial Breast Irradiation

Baseline characteristics by cohort

Measure	Radiation Therapy Followed by Lumpectom n=35 Participants Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy Phase II - Preoperative Radiation followed by Lumpectomy.: Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	63.4 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

The number of subjects with one or more postoperative complications following preoperative accelerated partial breast irradiation within three months of surgery.

Outcome measures

Measure

Radiation Therapy Followed by Lumpectom n=35 Participants Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy Phase II - Preoperative Radiation followed by Lumpectomy.: Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.

Postoperative Complications Following

4 Participants

SECONDARY outcome

Timeframe: 5 Years

Number of subjects with re-excision following surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 Years

The number of patients alive at five years.

Outcome measures

Outcome data not reported

Adverse Events

Radiation Therapy Followed by Lumpectom

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure

Radiation Therapy Followed by Lumpectom n=35 participants at risk Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy Phase II - Preoperative Radiation followed by Lumpectomy.: Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.

Vascular disorders Thromboembolic event other - specify

2.9% 1/35 • Number of events 1 • 5 years

Other adverse events

Measure	Radiation Therapy Followed by Lumpectom n=35 participants at risk Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy Phase II - Preoperative Radiation followed by Lumpectomy.: Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.
General disorders Edema limbs	2.9% 1/35 • Number of events 1 • 5 years
General disorders Fatigue	11.4% 4/35 • Number of events 4 • 5 years
General disorders Localized edema	2.9% 1/35 • Number of events 1 • 5 years
General disorders Non-cardiac chest pain	2.9% 1/35 • Number of events 2 • 5 years
Infections and infestations Breast infection	2.9% 1/35 • Number of events 1 • 5 years
Injury, poisoning and procedural complications Dermatitis radiation	8.6% 3/35 • Number of events 3 • 5 years
Injury, poisoning and procedural complications Fracture	5.7% 2/35 • Number of events 2 • 5 years
Reproductive system and breast disorders Breast tenderness	5.7% 2/35 • Number of events 2 • 5 years
Skin and subcutaneous tissue disorders Pruritus	5.7% 2/35 • Number of events 2 • 5 years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Oher, specify	2.9% 1/35 • Number of events 1 • 5 years
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.9% 1/35 • Number of events 1 • 5 years

Additional Information

Adam Currey, MD

Froedtert and the Medical college of Wisconsin

Phone: 414-805-4462

Email: acurrey@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place