Trial Outcomes & Findings for Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery (NCT NCT01754519)

NCT ID: NCT01754519

Last Updated: 2017-07-07

Results Overview

Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Up to 2 years
• Results posted on: 2017-07-07

Participant Flow

Participant milestones

Measure	Treatment (Radiation Therapy) Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery

Baseline characteristics by cohort

Measure	Treatment (Radiation Therapy) n=1 Participants Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Age, Continuous	65 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: All treated and eligible patients

Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.

Outcome measures

Measure	Treatment (Radiation Therapy) n=1 Participants Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
Number of Patients With Adverse Events as a Measure of Safety and Tolerability	1 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 2 years

Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 5 years

Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

The overall survival will be analyzed using Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.

The disease specific survival will be analyzed using Kaplan-Meier method.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Radiation Therapy)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment (Radiation Therapy) n=1 participants at risk Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. Therapeutic Conventional Surgery: Undergo wide local excision breast surgery Radiation Therapy: Undergo SFRT Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
General disorders Fibrosis	100.0% 1/1 • Number of events 1
General disorders Pain	100.0% 1/1 • Number of events 1
Injury, poisoning and procedural complications Contusion	100.0% 1/1 • Number of events 1
Injury, poisoning and procedural complications Seroma	100.0% 1/1 • Number of events 1
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 1/1 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	100.0% 1/1 • Number of events 1
Reproductive system and breast disorders Breast oedema	100.0% 1/1 • Number of events 1
Reproductive system and breast disorders Breast pain	100.0% 1/1 • Number of events 1

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Results disclosure agreements

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